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The purpose of phase 1 part in this study was to determine the maximum tolerated dose (MTD) and/or recommended expansion dose (RED) of ASP2215 concomitant with cytarabine/idarubicin as induction chemotherapy based on the status of the onset of dose-limiting toxicity (DLT) in newly diagnosed Acute Myeloid Leukemia (AML) subjects. Phase 1 part also evaluated safety and tolerability and characterized the pharmacokinetic (PK) parameters of ASP2215 concomitant with induction and consolidation chemotherapy as well as evaluated the PK parameters of cytarabine concomitant with ASP2215.
The purpose of phase 2 part was to evaluate efficacy of ASP2215 in combination with induction therapy. Phase 2 cohort also evaluated safety and characterized the PK parameters of ASP2215 in combination with induction and consolidation therapy followed by maintenance therapy in newly diagnosed FLT3-mutated AML subjects.
This study was composed of Phase 1 part (the dose-evaluation part and the expansion part) and Phase 2 part.
In the dose-evaluation part of Phase 1 part, at least 3 subjects received ASP2215 at each dose (low, middle, and high) for determination of MTD and/or RED. Treatment of AML in Phase 1 part was composed of 3 periods of therapy: remission induction, consolidation, and maintenance. The decision of whether or not to proceed to the next dose was made based on the occurrence of DLT during Cycle 1 of the induction period.
In the expansion part of Phase 1 part, a maximum of 3 subjects received ASP2215 at RED that had been recommended in the dose-evaluation part and the safety was assessed based on the onset of DLTs during Cycle 1 of the induction and consolidation periods.
In Phase 2 part, Subjects received ASP2215 at the recommended dose established in Phase 1 part. The target population was limited to newly diagnosed FLT3-mutated AML.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1: Dose Evaluation (DEv) | Experimental | Induction period: Participants received 120 milligrams (mg) gilteritinib (3 tablets of 40 mg) orally, once daily from day 4 to 17 combined with chemotherapy (idarubicin: 12 mg per square meters per day [mg/m^2/day] on days 1 to 3, cytarabine: 100 mg/m^2/day on days 1 to 7) via intravenous (IV) infusion; in cycles (C) 1 and 2 (1 cycle= 42 days). Consolidation period: Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once daily from day 1 to 14 combined with chemotherapy (cytarabine: 1500 mg/m^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3 (1 cycle= 28 days). Duration of infusion was determined by site clinical practice and local package insert in both induction and consolidation periods.. Maintenance period: Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once daily from days 1 to 28 in the maintenance period in C1 to 26 or untill discontinuation criterion is met (1 cycle= 28 days). |
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| Phase 1: Dose Expansion (DEx) | Experimental | Induction period: Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 4 to 17 in combination with chemotherapy (idarubicin: 12 mg/m^2/day on days 1 to 3, cytarabine: 100 mg/m^2/day on days 1 to 7) via IV infusion; in the induction period in C1 and 2 (1 cycle= 42 days). Consolidation period: Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 14 in combination with chemotherapy (cytarabine: 1500 mg/m^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3 (1 cycle= 28 days). Duration of infusion was determined based on site clinical practice and the local package insert in both induction and consolidation periods. Maintenance period: Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gilteritinib | Drug | Once-daily oral administration on 14 consecutive days in every cycle in each period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1 Part: Maximum Tolerated Dose (MTD) of Gilteritinib | The MTD was defined as the highest dose of gilteritinib at which the posterior mean of the DLT incidence during Cycle 1 of induction therapy was estimated to be closest to 33%. | Day 1 up to the end of Induction period cycle 1 (up to 42 days) |
| Phase 1 Part: Recommended Expansion Dose (RED) of Gilteritinib | RED was the recommended dose used in Phase 2 of the study that was decided by the sponsor's responsible person by comprehensively assessing the data obtained from the study. | Day 1 up to the end of Induction period cycle 1 (up to 42 days) |
| Phase 1 Part: Number of Participants With Dose Limiting Toxicities (DLTs) of Gilteritinib | DLTs were defined as: Any Grade ≥ 3 non-hematologic or extramedullary toxicity with the following exceptions:
DLT was assessed until cycle 1 of dose evaluation induction period and until cycle 1 of dose expansion consolidation period. | Day 1 up to the end of Consolidation Cycle 1 (approximately up to 4 months) |
| Phase 1 Part: Number of Participants With Treatment Emergent Adverse Events (TEAEs) | An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE could therefore be any unfavorable & unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. TEAE included both serious and non-serious AEs. TEAE for Phase 1 was defined as an AE observed after the date of first dose until 30 days after the last dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1 Part: Maximum Concentration (Cmax) of Gilteritinib Concomitant With Induction and Consolidation Chemotherapy | Cmax was derived from the PK samples collected. It was planned that standard deviation(SD) would only be calculated if there are more than 3 participants analyzed otherwise, SD was not calculated. | Induction period: Pre-dose, 1, 2, 4, 6, 10, and 24 hours post-dose on Cycle 1 Day 4 Consolidation period: Pre-dose, 1, 2, 4, 6, 10, and 24 hours post-dose on Cycle 1 Day 1 |
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Inclusion Criteria:
[Phase 1 part]
Subject is defined as having previously untreated de novo AML according to the World Health Organization (WHO) criteria (2008) within 28 days prior to study enrollment.
Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
Subject must meet all of the following criteria in the laboratory test at screening:
Subject is suitable for oral administration of ASP2215.
Female subject falls under the following:
Female subject agrees not to breastfeed starting at screening and throughout the study period and for 60 days after the final study drug administration.
Female subject agrees not to donate ova starting at screening and throughout the study period and for 60 days after the final study drug administration.
Male subject and his female spouse/partner who is of childbearing potential agrees to use an appropriate contraception starting at screening and throughout the study period and for 120 days after the final study drug administration.
Male subject agrees not to donate sperm starting at screening and throughout the study period and for 120 days after the final study drug administration.
Subject agrees not to participate in another interventional study while on study treatment.
Subject can be admitted during the induction period.
[Phase 2 part]
Subject has a diagnosis of previously-untreated de novo acute myeloid leukemia (AML) according to World Health Organization (WHO) classification (2017) documented within 28 days prior to enrollment.
Subject is positive for FLT3-ITD and/or TKD mutation in bone marrow or whole blood as determined by the central lab. Registration by the local lab result is not acceptable.
Subject has an ECOG performance status (PS) 0 to 1. Subject who has an ECOG PS 2 is eligible only if the primary disease related symptoms such as pneumonia and febrile neutropenia are the cause of PS score.
Subject is suitable for oral administration of ASP2215.
Female subject is not pregnant and at least 1 of the following conditions apply:
Female subject must agree not to breastfeed starting at screening and throughout the study period, and for 60 days after the final study drug administration.
Female subject must not donate ova starting at screening and throughout the study period, and for 180 days after the final study drug administration.
Male subject and their female partners who are of childbearing potential must be using highly effective contraception per locally accepted standards in addition to a barrier method starting at screening and continue throughout the study period and for 120 days after the final study drug administration.
Male subject must not donate sperm starting at screening and throughout the study period and for 120 days after the final study drug administration.
Male subject with pregnant partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy throughout the study period and for 120 days after the final study treatment administration.
Subject agrees not to participate in another interventional study while on treatment.
Subject must meet the following criteria as indicated on the clinical laboratory tests:
Exclusion Criteria:
[Phase 1 part]
Subject was diagnosed with acute promyelocytic leukemia (APL).
Subject has breakpoint cluster region-abelson (BCR-ABL)-positive leukemia (chronic myelogenous leukemia in blast crisis).
Subject has active malignant tumors other than AML or myelodysplastic syndrome (MDS).
Subject has received prior AML treatment except for the following:
Subject has clinically active central nervous system leukemia.
Subject has disseminated intravascular coagulation (DIC).
Subject has had major surgery within 28 days prior to the first study drug administration.
Subject has had radiation therapy within 28 days prior to the first study drug administration.
Subject has congestive heart failure of New York Heart Association (NYHA) class 3 or 4, or subject with a past history of congestive heart failure of NYHA class 3 or 4 and in whom echocardiogram (ECHO) or Multiple Gate Acquisition (MUGA) scan performed within 3 months prior to screening or at screening showed a left ventricular ejection fraction (LVEF) of < 45%.
Subject has cardiac impairment or a clinically significant cardiac disease, including any one of the following:
Subject requires treatment with concomitant drugs that are strong inducers of cytochrome P450 (CYP)3A.
Subject requires treatment with concomitant drugs that are strong inhibitors or inducers of P glycoprotein (P-gp) with the exception of drugs that are considered absolutely essential for the care of the subject.
Subject requires treatment with concomitant drugs that target serotonin 5HT1 or 5HT2B receptors or sigma receptors, with the exception of drugs that are considered absolutely essential for treatment of the subject.
Subject has an active uncontrollable infection.
Subject is known to have human immunodeficiency virus (HIV) infection.
Subject has active hepatitis B or C or other active hepatic disorders.
Subject has any condition that, in the investigator's or sub-investigator's opinion, makes the subject unsuitable for study participation.
Potassium and magnesium levels of below institutional lower limit of normal in the laboratory test at screening.
[Phase 2 part]
Subject was diagnosed with acute promyelocytic leukemia (APL).
Subject has known BCR-ABL-positive leukemia (chronic myelogenous leukemia in blast crisis).
Subject has therapy-related AML.
Subject has active malignant tumors other than AML.
Subject has received previous therapy for AML, with the exception of the following:
Subject has QTcF interval > 450 ms (average of triplicate determinations based on central reading).
Subject with long QT syndrome.
Subject has clinically active central nervous system leukemia.
Subject has had major surgery within 4 weeks prior to the first study dose.
Subject has radiation therapy within 4 weeks prior to the first study dose.
Subject has immediate life-threatening, severe complications of leukemia such as severe uncontrolled bleeding and/or severe disseminated intravascular coagulation
Subject is known to have human immunodeficiency virus infection.
Subject has active hepatitis B or C.
Subject has an uncontrolled infection. An infection controlled with an approved or closely monitored antibiotic/antiviral/antifungal treatment is allowed.
Subject has uncontrolled angina, severe uncontrolled ventricular arrhythmias, electrocardiographic evidence of acute ischemia, congestive heart failure New York Heart Association (NYHA) class 3 or 4 or subject has a history of congestive heart failure of NYHA class 3 or 4 and echocardiogram (ECHO) or Multiple Gate Acquisition (MUGA) scan performed within 3 months prior to screening or at screening showed a left ventricular ejection fraction (LVEF) of < 45%.
Subject requires treatment with concomitant drugs that are strong inducers of cytochrome P450 (CYP) 3A.
Subject requires treatment with concomitant drugs that target serotonin 5HT2B receptors or sigma nonspecific receptors, with the exception of drugs that are considered absolutely essential for treatment of the subject.
Subject requires treatment with concomitant drugs that are strong inhibitors or inducers of P glycoprotein (P-gp) with the exception of drugs that are considered absolutely essential for the care of the subject.
Subject has prior malignancies, except resected basal cell carcinoma or treated cervical carcinoma in situ. Cancer treated with curative intent ≥ 5 years previously will be allowed. Cancer treated with curative intent < 5 years previously will not be allowed.
Subject has any condition which makes the subject unsuitable for study participation.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Astellas Pharma Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site JP81037 | Anjo | Aichi-ken | Japan | |||
| Site JP00003 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41835842 | Derived | Sawa M, Miyamoto T, Kim HJ, Hiramatsu Y, Cheong JW, Ikezoe T, Naoe T, Akashi K, Morita S, Kosako M, Shimura M, Terada W, Kadokura T, Hill J, Miyawaki S, Gill SC, Heinloth A, Hasabou N. A phase I/II study of gilteritinib in combination with chemotherapy in newly diagnosed patients with AML in Asia: final analysis. Ther Adv Hematol. 2026 Mar 11;17:20406207261419953. doi: 10.1177/20406207261419953. eCollection 2026. |
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Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
Participants who met all inclusion criteria and none of the exclusion criteria were enrolled in the study.
Participants with newly diagnosed acute myeloid leukemia (AML) and participants newly diagnosed FMS-like tyrosine kinase-3, FMS-related tyrosine kinase 3 (FLT3)-mutated AML; were enrolled in Phase 1 and Phase 2, respectively.
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase 1: Dose Evaluation (DEv) | Induction period (IP): Participants received 120 milligrams (mg) gilteritinib (3 tablets of 40 mg) orally, once a day from days 4 to 17 in combination with chemotherapy (idarubicin: 12 milligrams per square meters per day [mg/m^2/day] on days 1 to 3, cytarabine: 100 mg/m^2/day on days 1 to 7) via intravenous (IV) infusion; in the induction period in cycles (C) 1 and 2 (1 cycle= 42 days). Duration of infusion was determined based on site clinical practice and the local package insert. Consolidation period (CP): Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 14 in combination with chemotherapy (cytarabine: 1500 mg/m^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3 (1 cycle= 28 days). Duration of infusion was determined based on site clinical practice and the local package insert. Maintenance period (MP): Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Phase 1(DEv):IP (2 Cycles;42 Days/Cycle) |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 29, 2021 | Jul 3, 2025 |
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| Phase 2: FLT3-mutated AML | Experimental | Induction period: Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once daily from days 8 until blood recovery combined with chemotherapy (idarubicin: 12 mg/m^2/day on days 1 to 3, cytarabine: 100 mg/m^2/day on days 1 to 7) via IV infusion; in C1 and 2. Each cycle was extended until blood recovery was observed. Consolidation period: Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once daily from days 1 until blood recovery combined with chemotherapy (cytarabine: 1500 mg/m^2, twice daily on days 1, 3, and 5) via IV infusion; in C1 to 3. Each cycle was extended until blood recovery was observed. Duration of infusion was based on site clinical practice and the local package insert in both induction and consolidation periods. Maintenance period: Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once daily from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days). |
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| Idarubicin | Drug | Induction period: Once-daily intravenous injection of 12 mg/m^2 idarubicin on 3 consecutive days. |
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| Cytarabine | Drug | Induction period: Once-daily intravenous injection of 100 mg/m^2 cytarabine on 7 consecutive days. Consolidation period: Twice-daily intravenous injection of 1.5 g/m^2 cytarabine on Days 1, 3, and 5. |
|
| From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) |
| Phase 2 Part: Complete Remission (CR) Rate: Induction Period | Percentage of participants with CR was reported. CR was defined as a morphologically leukemia-free state at the post-baseline visit, having a neutrophil count of ≥ 1,000/mm3 and platelet count of ≥ 100,000/mm3, bone marrow blasts < 5%. No evidence of Auer rods and no evidence of extramedullary leukemia. The blast counts in peripheral blood was ≤ 2%. | From the date of first dose up to the start of Consolidation (approximately up to 4 months) |
| Phase 1 Part: Time to Attain Cmax (Tmax) of Gilteritinib Concomitant With Induction and Consolidation Chemotherapy | Tmax was derived from the PK samples collected. | Induction period: Pre-dose, 1, 2, 4, 6, 10, and 24 hours post-dose on Cycle 1 Day 4 Consolidation period: Pre-dose, 1, 2, 4, 6, 10, and 24 hours post-dose on Cycle 1 Day 1 |
| Phase 1 Part: Area Under Plasma Concentration-time Curve From Time 0 to 24 (AUC24) of Gilteritinib Concomitant With Induction and Consolidation Chemotherapy | AUC24 was derived from the PK samples collected. It was planned that standard deviation(SD) would only be calculated if there are more than 3 participants analyzed otherwise, SD was not calculated. | Induction period: Pre-dose, 1, 2, 4, 6, 10, and 24 hours post-dose on Cycle 1 Day 4 Consolidation period: Pre-dose, 1, 2, 4, 6, 10, and 24 hours post-dose on Cycle 1 Day 1 |
| Phase 1 Part: Area Under The Concentration-Time Curve From The Time Zero to The Last Measurable Concentration (AUClast) of Gilteritinib Concomitant With Induction and Consolidation Chemotherapy | AUClast was derived from the PK samples collected. It was planned that standard deviation(SD) would only be calculated if there are more than 3 participants analyzed otherwise, SD was not calculated. | Induction period: Pre-dose, 1, 2, 4, 6, 10, and 24 hours post-dose on Cycle 1 Day 4 Consolidation period: Pre-dose, 1, 2, 4, 6, 10, and 24 hours post-dose on Cycle 1 Day 1 |
| Phase 1 Part: Plasma Trough Concentration (Ctrough) of Gilteritinib Concomitant With Induction and Consolidation Chemotherapy | Ctrough is the plasma concentration prior to drug administration. It was planned that standard deviation(SD) would only be calculated if there are more than 3 participants analyzed otherwise, SD was not calculated. | Induction period: Pre-dose on Cycle 1 Day 8, 11, and 17 Consolidation period: Pre-dose on Cycle 1 Day 6 and 15 |
| Phase 1 Part: Plasma Trough Concentration of Cytarabine Concomitant With Gilteritinib With Induction and Consolidation Period | Ctrough is the plasma concentration prior to drug administration. It was planned that standard deviation(SD) would only be calculated if there are more than 3 participants analyzed otherwise, SD was not calculated. | Induction period: Predose on Cycle 1 Day 1, 3, and 8 Consolidation period: Predose on Cycle 1 Day 2 and 6 |
| Phase 2 Part: Plasma Trough Concentration of Gilteritinib Concomitant With Induction and Consolidation Chemotherapy | Ctrough is the plasma concentration prior to drug administration. | Induction period : Predose on Cycle 1 Day 15 and 21 Consolidation period: Predose on Cycle 1 Day 8 and 15 |
| Phase 2 Part: Overall Survival (OS) | Overall survival (OS) was defined as the time from the date of first dose of day 1 to the date of death due to any cause. Participants still alive or lost to follow up was censored at the time they were last known to be alive. Kaplan-Meier (KM) estimate was used for analysis. | From the date of first dose up to the date of death (maximum duration: approximately 4.4 years) |
| Phase 2 Part: Event Free Survival (EFS) | Event-free survival (EFS): time from date of first dose of study regimen until date of documented relapse, treatment failure or death from any cause, whichever occurred first. KM estimate was used for analysis. Relapse: reappearance of leukemic blasts in peripheral blood (>2%)/≥ 5% blasts in bone marrow aspirate (BMA)/reappearance of significant numbers of peripheral blasts and an increase in percentage of blasts in BMA to > 25%. Treatment failure: participants who failed to achieve composite complete remission (CRc) or who discontinued treatment due to "lack of efficacy" without previous response. CRc: rate of all complete & incomplete remissions i.e. CR + CR with incomplete platelet recovery (CRp) + CR with incomplete hematological recover (CRi). CRp: met all CR criteria at post-baseline visit, except unrecovered platelet count (< 100,000/mm^3). CRi: met all CR criteria at post-baseline visit, except unrecovered neutrophil count (< 1,000/mm^3). CR: defined in outcome measure #5. | From the date of first dose up to the date of documented relapse, treatment failure or death from any cause (maximum duration: approximately 4.4 years) |
| Phase 2 Part: Relapse Free Survival (RFS) | Relapse-free survival (RFS): time from date of achievement of first CRc until relapse or death from any cause. KM estimate was used for analysis. Relapse: reappearance of leukemic blasts in peripheral blood (>2%)/≥ 5% blasts in bone marrow aspirate (BMA)/reappearance of significant numbers of peripheral blasts and an increase in percentage of blasts in BMA to > 25%. CRc: rate of all complete & incomplete remissions i.e. CR + CR with incomplete platelet recovery (CRp) + CR with incomplete hematological recover (CRi). CRp: met all CR criteria at post-baseline visit, except unrecovered platelet count (< 100,000/mm^3). CRi: met all CR criteria at post-baseline visit, except unrecovered neutrophil count (< 1,000/mm^3). CR: morphologically leukemia-free state at post-baseline visit, having neutrophil count of ≥ 1,000/mm^3 and platelet count of ≥ 100,000/mm^3, bone marrow blasts < 5%. No evidence of Auer rods & extramedullary leukemia. Blast counts in peripheral blood was ≤ 2%. | From the date of achievement of first CRc up to the date of documented relapse or death from any cause (maximum duration: approximately 3.9 years) |
| Phase 2 Part: CR Rate After Consolidation and Maintenance Period | Percentage of participants with CR was reported. CR was defined as a morphologically leukemia-free state at the post-baseline visit, having a neutrophil count of ≥ 1,000/mm^3 and platelet count of ≥ 100,000/mm^3, bone marrow blasts < 5%. No evidence of Auer rods and no evidence of extramedullary leukemia. The blast counts in peripheral blood was ≤ 2%. Derived response assessment after the consolidation period refers to the best response from the start of treatment in the induction period until the end of the consolidation period and for the maintenance period refers to the best response from the start of treatment in the induction period until the end of the maintenance period. | CP: From date of first dose up to end of period (approximately 1.8 years), MP: From date of first dose up to the end of period (approximately 3.8 years) |
| Phase 2 Part: CR Rate Without Minimal Residual Disease (MRD) After Each Treatment Therapy Period | CR% without MRD reported. CR rate without MRD after each treatment therapy was defined similarly as CR rate after each treatment therapy. Responders achieve that the best response is CR and MRD status was negative. CR was defined as a morphologically leukemia-free state, having a neutrophil count of ≥ 1,000/mm^3 and platelet count of ≥ 100,000/mm^3, bone marrow blasts < 5%. No evidence of Auer rods and extramedullary leukemia. The blast counts in peripheral blood was ≤ 2%. Derived response assessment after the IP refers to the best response from the start of treatment in the IP until the end of the IP, after CP refers to the best response from the start of treatment in the IP until the end of the CP and for the MP refers to the best response from the start of treatment in the IP until the end of the MP. | IP: From date of first dose up to end of period (approximately 1.4 years), CP: From date of first dose up to end of period (approximately 1.8 years), MP: From date of first dose up to the end of period (approximately 3.8 years) |
| Phase 2 Part: CR With Partial Hematological Recovery (CRh) Rate After Each Treatment Therapy Period | Percentage of participants with CRh was reported. CRh was defined as a condition at the post baseline visit, having bone marrow blasts < 5%, partial hematologic recovery neutrophil count≥ 500/mm^3 and platelet count ≥ 50,000/mm^3, no evidence of extramedullary leukemia and could be classified as CR. The blast counts in peripheral blood was ≤ 2%. Derived response assessment after the IP refers to the best response from the start of treatment in the IP until the end of the IP, after CP refers to the best response from the start of treatment in the IP until the end of the CP and for the MP refers to the best response from the start of treatment in the IP until the end of the MP. | IP: From date of first dose up to end of period (approximately 1.4 years), CP: From date of first dose up to end of period (approximately 1.8 years), MP: From date of first dose up to the end of period (approximately 3.8 years) |
| Phase 2 Part: Composite CR (CRc) Rate After Each Treatment Therapy Period | Percentage of participants with CRc reported. CRc: rate of all complete & incomplete remissions i.e. CR + CR with incomplete platelet recovery (CRp) + CR with incomplete hematological recovery (CRi). CRp: met all CR criteria, except unrecovered platelet count (< 100,000/mm^3). CRi: met all CR criteria, except unrecovered neutrophil count (< 1,000/mm^3). CR: morphologically leukemia-free state, having neutrophil count of ≥ 1,000/mm^3 and platelet count of ≥ 100,000/mm^3, bone marrow blasts < 5%. No evidence of Auer rods & extramedullary leukemia. Blast counts in peripheral blood was ≤ 2%. Derived response assessment after the IP refers to the best response from the start of treatment in the IP until the end of the IP, after CP refers to the best response from the start of treatment in the IP until the end of the CP and for the MP refers to the best response from the start of treatment in the IP until the end of the MP. | IP: From date of first dose up to end of period (approximately 1.4 years), CP: From date of first dose up to end of period (approximately 1.8 years), MP: From date of first dose up to the end of period (approximately 3.8 years) |
| Phase 2 Part: CR/CRh Rate After Each Treatment Therapy Period | Percentage of participants with CR/CRh was reported. CR was defined as a morphologically leukemia-free state at the post-baseline visit, having a neutrophil count of ≥ 1,000/mm^3 and platelet count of ≥ 100,000/mm^3, bone marrow blasts < 5%. No evidence of Auer rods and no evidence of extramedullary leukemia. The blast counts in peripheral blood was ≤ 2%. CRh was defined as a condition at the post baseline visit, having bone marrow blasts < 5%, partial hematologic recovery neutrophil count≥ 500/mm^3 and platelet count ≥ 50,000/mm^3, no evidence of extramedullary leukemia and could be classified as CR. The blast counts in peripheral blood was ≤ 2%. Derived response assessment after the IP refers to the best response from the start of treatment in the IP until the end of the IP, after CP refers to the best response from the start of treatment in the IP until the end of the CP and for the MP refers to the best response from the start of treatment in the IP until the end of the MP. | IP: From date of first dose up to end of period (approximately 1.4 years), CP: From date of first dose up to end of period (approximately 1.8 years), MP: From date of first dose up to the end of period (approximately 3.8 years) |
| Phase 2 Part: Duration of CR | Duration of CR was defined as the time from the date of achieving first CR until the date of first documented relapse for participants who achieved CR. KM estimate was used for analysis. CR was defined as a morphologically leukemia-free state at the post-baseline visit, having a neutrophil count of ≥ 1,000/mm^3 and platelet count of ≥ 100,000/mm^3, bone marrow blasts < 5%. No evidence of Auer rods and no evidence of extramedullary leukemia. The blast counts in peripheral blood was ≤ 2%. Relapse: reappearance of leukemic blasts in peripheral blood (>2%)/≥ 5% blasts in BMA/reappearance of numbers of peripheral blasts and an increase in percentage of blasts in BMA to > 25%. | From the date of achieving CR up to the date of documented relapse (maximum duration: approximately 2.6 years) |
| Phase 2 Part: Duration of CR/CRh | Duration of CR/CRh is defined as the time from the date of achieving first CR/CRh until the date of first documented relapse for participants who achieved CR/CRh. KM estimate was used for analysis. CR was defined as a morphologically leukemia-free state at the post-baseline visit, having a neutrophil count of ≥ 1,000/mm^3 and platelet count of ≥ 100,000/mm^3, bone marrow blasts < 5%. No evidence of Auer rods and no evidence of extramedullary leukemia. The blast counts in peripheral blood was ≤ 2%. CRh was defined as a condition at the post baseline visit, having bone marrow blasts < 5%, partial hematologic recovery neutrophil count≥ 500/mm^3 and platelet count ≥ 50,000/mm^3, no evidence of extramedullary leukemia and could be classified as CR. The blast counts in peripheral blood was ≤ 2%. Relapse: reappearance of leukemic blasts in peripheral blood (>2%)/≥ 5% blasts in BMA/reappearance of numbers of peripheral blasts and an increase in percentage of blasts in BMA to > 25%. | From the date of achieving CR/CRh up to the date of documented relapse (maximum duration: approximately 2.6 years) |
| Phase 2 Part: Duration of CRh | Duration of CRh was defined as the time from date of achieving first CRh until date of first documented relapse for participants who achieved CRh. KM estimate was used for analysis. CRh was defined as a condition at the post baseline visit, having bone marrow blasts < 5%, partial hematologic recovery neutrophil count≥ 500/mm^3 and platelet count ≥ 50,000/mm^3, no evidence of extramedullary leukemia and could be classified as CR. The blast counts in peripheral blood was ≤ 2%. Relapse: reappearance of leukemic blasts in peripheral blood (>2%)/≥ 5% blasts in BMA/reappearance of numbers of peripheral blasts and an increase in percentage of blasts in BMA to > 25%. | From the date of achieving CRh up to the date of documented relapse (maximum duration: approximately 2.6 years) |
| Phase 2 Part: Duration of CRc | Duration of CRc is defined as the time from the date of achieving first CRc until the date of first documented relapse for participants who achieved CRc. KM estimate was used for analysis. CRc: rate of all complete & incomplete remissions i.e. CR + CR with incomplete platelet recovery (CRp) + CR with incomplete hematological recover (CRi). CRp: met all CR criteria at post-baseline visit, except unrecovered platelet count (< 100,000/mm^3). CRi: met all CR criteria at post-baseline visit, except unrecovered neutrophil count (< 1,000/mm^3). CR: morphologically leukemia-free state at post-baseline visit, having neutrophil count of ≥ 1,000/mm^3 and platelet count of ≥ 100,000/mm^3, bone marrow blasts < 5%. No evidence of Auer rods & extramedullary leukemia. Blast counts in peripheral blood was ≤ 2%. Relapse: reappearance of leukemic blasts in peripheral blood (>2%)/≥ 5% blasts in BMA/reappearance of numbers of peripheral blasts and an increase in percentage of blasts in BMA to > 25%. | From the date of achieving CRc up to the date of documented relapse (maximum duration: approximately 2.7 years) |
| Phase 2 Part: Duration of Response (DoR) | DoR: from first day of achieving CRc (CR+ CRp,+CRi)/partial remission (PR) to first day of relapse. KM estimate was used for analysis. CR: morphologically leukemia-free state at post-baseline visit, having neutrophil count of ≥ 1,000/mm^3 & platelet count of ≥ 100,000/mm^3, bone marrow blasts < 5%. No evidence of Auer rods & extramedullary leukemia. Peripheral blood blast counts was ≤ 2%. CRp: met all CR criteria at post-baseline visit, except unrecovered platelet count (< 100,000/mm^3). CRi: met all CR criteria at post-baseline visit, except unrecovered neutrophil count (< 1,000/mm^3). PR: condition with regeneration of normal hematopoietic cells in bone marrow, no detectable blasts, ≥ 50% decrease of blasts in BMA & total bone marrow blasts of 5-25%. No evidence of extramedullary leukemia. Relapse: reappearance of leukemic blasts in peripheral blood (>2%)/≥ 5% blasts in BMA/reappearance of numbers of peripheral blasts and an increase in percentage of blasts in BMA to > 25% | From the date of achieving CR, CRp, CRi/PR up to the date of documented relapse (maximum duration: approximately 2.7 years) |
| Phase 2 Part: Number of Participants With Treatment Emergent Adverse Events (TEAEs) | An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE could therefore be any unfavorable & unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. TEAE for Phase 2 was defined as an AE observed after the date of first dose until 30 days after the last dose. TEAE included both serious and non-serious AEs. | From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) |
| Nagoya |
| Aichi-ken |
| Japan |
| Site JP81003 | Nagoya | Aichi-ken | Japan |
| Site JP81027 | Nagoya | Aichi-ken | Japan |
| Site JP81038 | Toyohashi | Aichi-ken | Japan |
| Site JP81010 | Narita | Chiba | Japan |
| Site JP81039 | Matsuyama | Ehime | Japan |
| Site JP81007 | Yoshida-gun | Fukui | Japan |
| Site JP00002 | Maebashi | Gunma | Japan |
| Site JP81001 | Maebashi | Gunma | Japan |
| Site JP81026 | Fukuyama | Hiroshima | Japan |
| Site JP81018 | Ōtake | Hiroshima | Japan |
| Site JP81014 | Sapporo | Hokkaido | Japan |
| Site JP81015 | Sapporo | Hokkaido | Japan |
| Site JP81043 | Himeji | Hyōgo | Japan |
| Site JP00007 | Kobe | Hyōgo | Japan |
| Site JP81006 | Kobe | Hyōgo | Japan |
| Site JP81036 | Mito | Ibaraki | Japan |
| Site JP81023 | Tsukuba | Ibaraki | Japan |
| Site JP81020 | Kanazawa | Ishikawa-ken | Japan |
| Site JP81013 | Isehara | Kanagawa | Japan |
| Site JP00006 | Yokohama | Kanagawa | Japan |
| Site JP81005 | Yokohama | Kanagawa | Japan |
| Site JP81024 | Yokohama | Kanagawa | Japan |
| Site JP81035 | Sendai | Miyagi | Japan |
| SIte JP81011 | Ōmura | Nagasaki | Japan |
| Site JP81041 | Tenri | Nara | Japan |
| Site JP81022 | Shimono | Tochigi | Japan |
| Site JP81040 | Bunkyo-ku | Tokyo | Japan |
| Site JP00005 | Shinagawa-ku | Tokyo | Japan |
| Site JP81032 | Shinagawa-ku | Tokyo | Japan |
| Site JP81029 | Akita | Japan |
| Site JP81008 | Chiba | Japan |
| Site JP00001 | Fukuoka | Japan |
| Site JP81004 | Fukuoka | Japan |
| Site JP81025 | Fukuoka | Japan |
| Site JP81031 | Fukushima | Japan |
| Site JP81030 | Gifu | Japan |
| Site JP81033 | Kochi | Japan |
| Site JP81028 | Kumamoto | Japan |
| Site JP81016 | Kyoto | Japan |
| Site JP81012 | Nagasaki | Japan |
| Site JP81009 | Okayama | Japan |
| Site JP81019 | Osaka | Japan |
| Site JP81021 | Osaka | Japan |
| Site KR82005 | Busan | South Korea |
| Site KR82002 | Incheon | South Korea |
| Site KR82001 | Seoul | South Korea |
| Site KR82003 | Seoul | South Korea |
| Site KR82004 | Seoul | South Korea |
| Site KR82006 | Seoul | South Korea |
| Site TW88604 | Kaohsiung City | Taiwan |
| Site TW88602 | Taichung | Taiwan |
| Site TW88601 | Tainan | Taiwan |
| Site TW88603 | Taoyuan | Taiwan |
| FG001 | Phase 1: Dose Expansion (DEx) | Induction period: Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 4 to 17 in combination with chemotherapy (idarubicin: 12 mg/m^2/day on days 1 to 3, cytarabine: 100 mg/m^2/day on days 1 to 7) via IV infusion; in the induction period in C1 and 2 (1 cycle= 42 days). Duration of infusion was determined based on site clinical practice and the local package insert. Consolidation period: Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 14 in combination with chemotherapy (cytarabine: 1500 mg/m^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3 (1 cycle= 28 days). Duration of infusion was determined based on site clinical practice and the local package insert. Maintenance period: Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days). |
| FG002 | Phase 2: FLT3-mutated AML | Induction period: Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 8 until blood recovery in combination with chemotherapy (idarubicin: 12 mg/m^2/day on days 1 to 3, cytarabine: 100 mg/m^2/day on days 1 to 7) via IV infusion; in the induction period in C1 and 2. Each cycle was allowed to be extended until blood recovery was observed. Duration of infusion was determined based on site clinical practice and the local package insert. Consolidation period: Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 until blood recovery in combination with chemotherapy (cytarabine: 1500 mg/m^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3. Each cycle was allowed to be extended until blood recovery was observed. Duration of infusion was determined based on site clinical practice and the local package insert. Maintenance period: Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days). |
| COMPLETED |
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| NOT COMPLETED |
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| Phase 1(DEv):CP (3 Cycles;28 Days/Cycle) |
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| Phase 1(DEv):MP(26 Cycles;28 Days/Cycle) |
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| Phase 1(DEx):IP (2 Cycles;42 Days/Cycle) |
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| Phase 1(DEx):CP (3 Cycles;28 Days/Cycle) |
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| Phase 1(DEx):MP(26 Cycles;28 Days/Cycle) |
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| Phase 2:IP(2 Cycles;up to 56 Days/Cycle) |
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| Phase 2:CP(4 Cycles;up to 28 Days/Cycle) |
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| Phase 2:MP(26 Cycles; 28 Days/Cycle) |
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Safety Analysis Set (SAF): All participants who received at least 1 dose of study drug were included.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Phase 1: Dose Evaluation (DEv) | Induction period: Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 4 to 17 in combination with chemotherapy (idarubicin: 12 mg/m^2/day on days 1 to 3, cytarabine: 100 mg/m^2/day on days 1 to 7) via IV infusion; in the induction period in C1 and 2 (1 cycle= 42 days). Duration of infusion was determined based on site clinical practice and the local package insert. Consolidation period: Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 14 in combination with chemotherapy (cytarabine: 1500 mg/m^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3 (1 cycle= 28 days). Duration of infusion was determined based on site clinical practice and the local package insert. Maintenance period: Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days). |
| BG001 | Phase 1: Dose Expansion (DEx) | Induction period: Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 4 to 17 in combination with chemotherapy (idarubicin: 12 mg/m^2/day on days 1 to 3, cytarabine: 100 mg/m^2/day on days 1 to 7) via IV infusion; in the induction period in C1 and 2 (1 cycle= 42 days). Duration of infusion was determined based on site clinical practice and the local package insert. Consolidation period: Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 14 in combination with chemotherapy (cytarabine: 1500 mg/m^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3 (1 cycle= 28 days). Duration of infusion was determined based on site clinical practice and the local package insert. Maintenance period: Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days). |
| BG002 | Phase 2: FLT3-mutated AML | Induction period: Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 8 until blood recovery in combination with chemotherapy (idarubicin: 12 mg/m^2/day on days 1 to 3, cytarabine: 100 mg/m^2/day on days 1 to 7) via IV infusion; in the induction period in C1 and 2. Each cycle was allowed to be extended until blood recovery was observed. Duration of infusion was determined based on site clinical practice and the local package insert. Consolidation period: Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 until blood recovery in combination with chemotherapy (cytarabine: 1500 mg/m^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3. Each cycle was allowed to be extended until blood recovery was observed. Duration of infusion was determined based on site clinical practice and the local package insert. Maintenance period: Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days). |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Phase 1 Part: Maximum Tolerated Dose (MTD) of Gilteritinib | The MTD was defined as the highest dose of gilteritinib at which the posterior mean of the DLT incidence during Cycle 1 of induction therapy was estimated to be closest to 33%. | Dose-Determining Analysis Set (DDAS) Phase 1 part: Participants who received more than 80% of the intended dose of gilteritinib and safety was adequately assessed during DLT assessment period specified in each part were included. | Posted | Number | miligram (mg) | Day 1 up to the end of Induction period cycle 1 (up to 42 days) |
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| Primary | Phase 1 Part: Recommended Expansion Dose (RED) of Gilteritinib | RED was the recommended dose used in Phase 2 of the study that was decided by the sponsor's responsible person by comprehensively assessing the data obtained from the study. | Participants in the DDAS. | Posted | Number | mg | Day 1 up to the end of Induction period cycle 1 (up to 42 days) |
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| Primary | Phase 1 Part: Number of Participants With Dose Limiting Toxicities (DLTs) of Gilteritinib | DLTs were defined as: Any Grade ≥ 3 non-hematologic or extramedullary toxicity with the following exceptions:
DLT was assessed until cycle 1 of dose evaluation induction period and until cycle 1 of dose expansion consolidation period. | Participants in the DDAS. | Posted | Number | Participants | Day 1 up to the end of Consolidation Cycle 1 (approximately up to 4 months) |
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| Primary | Phase 1 Part: Number of Participants With Treatment Emergent Adverse Events (TEAEs) | An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE could therefore be any unfavorable & unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. TEAE included both serious and non-serious AEs. TEAE for Phase 1 was defined as an AE observed after the date of first dose until 30 days after the last dose. | SAF | Posted | Number | Participants | From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) |
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| Primary | Phase 2 Part: Complete Remission (CR) Rate: Induction Period | Percentage of participants with CR was reported. CR was defined as a morphologically leukemia-free state at the post-baseline visit, having a neutrophil count of ≥ 1,000/mm3 and platelet count of ≥ 100,000/mm3, bone marrow blasts < 5%. No evidence of Auer rods and no evidence of extramedullary leukemia. The blast counts in peripheral blood was ≤ 2%. | Participants in the Full Analysis Set (FAS) Phase 2 part: Participants who received at least 1 dose of study drug and had at least one post-baseline bone marrow assessment were included. | Posted | Number | 90% Confidence Interval | Percentage of participants | From the date of first dose up to the start of Consolidation (approximately up to 4 months) |
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| Secondary | Phase 1 Part: Maximum Concentration (Cmax) of Gilteritinib Concomitant With Induction and Consolidation Chemotherapy | Cmax was derived from the PK samples collected. It was planned that standard deviation(SD) would only be calculated if there are more than 3 participants analyzed otherwise, SD was not calculated. | Pharmacokinetics Analysis Set (PKAS): Participants who received the study drug, from whom samples for drug concentration measurement were collected for at least 1 time-point after the study drug administration, and from whom drug concentration measurement was obtained were included. PKAS with available data analyzed. | Posted | Mean | Standard Deviation | nanograms per milliliter (ng/mL) | Induction period: Pre-dose, 1, 2, 4, 6, 10, and 24 hours post-dose on Cycle 1 Day 4 Consolidation period: Pre-dose, 1, 2, 4, 6, 10, and 24 hours post-dose on Cycle 1 Day 1 |
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| Secondary | Phase 1 Part: Time to Attain Cmax (Tmax) of Gilteritinib Concomitant With Induction and Consolidation Chemotherapy | Tmax was derived from the PK samples collected. | PKAS with available data analyzed. | Posted | Median | Full Range | hours | Induction period: Pre-dose, 1, 2, 4, 6, 10, and 24 hours post-dose on Cycle 1 Day 4 Consolidation period: Pre-dose, 1, 2, 4, 6, 10, and 24 hours post-dose on Cycle 1 Day 1 |
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| Secondary | Phase 1 Part: Area Under Plasma Concentration-time Curve From Time 0 to 24 (AUC24) of Gilteritinib Concomitant With Induction and Consolidation Chemotherapy | AUC24 was derived from the PK samples collected. It was planned that standard deviation(SD) would only be calculated if there are more than 3 participants analyzed otherwise, SD was not calculated. | PKAS with available data analyzed. | Posted | Mean | Standard Deviation | ng*hr/mL | Induction period: Pre-dose, 1, 2, 4, 6, 10, and 24 hours post-dose on Cycle 1 Day 4 Consolidation period: Pre-dose, 1, 2, 4, 6, 10, and 24 hours post-dose on Cycle 1 Day 1 |
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| Secondary | Phase 1 Part: Area Under The Concentration-Time Curve From The Time Zero to The Last Measurable Concentration (AUClast) of Gilteritinib Concomitant With Induction and Consolidation Chemotherapy | AUClast was derived from the PK samples collected. It was planned that standard deviation(SD) would only be calculated if there are more than 3 participants analyzed otherwise, SD was not calculated. | PKAS with available data analyzed. | Posted | Mean | Standard Deviation | ng*hr/mL | Induction period: Pre-dose, 1, 2, 4, 6, 10, and 24 hours post-dose on Cycle 1 Day 4 Consolidation period: Pre-dose, 1, 2, 4, 6, 10, and 24 hours post-dose on Cycle 1 Day 1 |
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| Secondary | Phase 1 Part: Plasma Trough Concentration (Ctrough) of Gilteritinib Concomitant With Induction and Consolidation Chemotherapy | Ctrough is the plasma concentration prior to drug administration. It was planned that standard deviation(SD) would only be calculated if there are more than 3 participants analyzed otherwise, SD was not calculated. | PKAS with available data analyzed. | Posted | Mean | Standard Deviation | ng/mL | Induction period: Pre-dose on Cycle 1 Day 8, 11, and 17 Consolidation period: Pre-dose on Cycle 1 Day 6 and 15 |
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| Secondary | Phase 1 Part: Plasma Trough Concentration of Cytarabine Concomitant With Gilteritinib With Induction and Consolidation Period | Ctrough is the plasma concentration prior to drug administration. It was planned that standard deviation(SD) would only be calculated if there are more than 3 participants analyzed otherwise, SD was not calculated. | PKAS with available data analyzed. | Posted | Mean | Standard Deviation | ng/mL | Induction period: Predose on Cycle 1 Day 1, 3, and 8 Consolidation period: Predose on Cycle 1 Day 2 and 6 |
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| Secondary | Phase 2 Part: Plasma Trough Concentration of Gilteritinib Concomitant With Induction and Consolidation Chemotherapy | Ctrough is the plasma concentration prior to drug administration. | PKAS with available data analyzed. | Posted | Mean | Standard Deviation | ng/mL | Induction period : Predose on Cycle 1 Day 15 and 21 Consolidation period: Predose on Cycle 1 Day 8 and 15 |
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| Secondary | Phase 2 Part: Overall Survival (OS) | Overall survival (OS) was defined as the time from the date of first dose of day 1 to the date of death due to any cause. Participants still alive or lost to follow up was censored at the time they were last known to be alive. Kaplan-Meier (KM) estimate was used for analysis. | Time-to-Event-FAS (TTE-FAS): All participants who received at least 1 dose of gilteritinib with or without postbaseline bone marrow assessments. | Posted | Median | 95% Confidence Interval | Months | From the date of first dose up to the date of death (maximum duration: approximately 4.4 years) |
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| Secondary | Phase 2 Part: Event Free Survival (EFS) | Event-free survival (EFS): time from date of first dose of study regimen until date of documented relapse, treatment failure or death from any cause, whichever occurred first. KM estimate was used for analysis. Relapse: reappearance of leukemic blasts in peripheral blood (>2%)/≥ 5% blasts in bone marrow aspirate (BMA)/reappearance of significant numbers of peripheral blasts and an increase in percentage of blasts in BMA to > 25%. Treatment failure: participants who failed to achieve composite complete remission (CRc) or who discontinued treatment due to "lack of efficacy" without previous response. CRc: rate of all complete & incomplete remissions i.e. CR + CR with incomplete platelet recovery (CRp) + CR with incomplete hematological recover (CRi). CRp: met all CR criteria at post-baseline visit, except unrecovered platelet count (< 100,000/mm^3). CRi: met all CR criteria at post-baseline visit, except unrecovered neutrophil count (< 1,000/mm^3). CR: defined in outcome measure #5. | TTE-FAS | Posted | Median | 95% Confidence Interval | Months | From the date of first dose up to the date of documented relapse, treatment failure or death from any cause (maximum duration: approximately 4.4 years) |
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| Secondary | Phase 2 Part: Relapse Free Survival (RFS) | Relapse-free survival (RFS): time from date of achievement of first CRc until relapse or death from any cause. KM estimate was used for analysis. Relapse: reappearance of leukemic blasts in peripheral blood (>2%)/≥ 5% blasts in bone marrow aspirate (BMA)/reappearance of significant numbers of peripheral blasts and an increase in percentage of blasts in BMA to > 25%. CRc: rate of all complete & incomplete remissions i.e. CR + CR with incomplete platelet recovery (CRp) + CR with incomplete hematological recover (CRi). CRp: met all CR criteria at post-baseline visit, except unrecovered platelet count (< 100,000/mm^3). CRi: met all CR criteria at post-baseline visit, except unrecovered neutrophil count (< 1,000/mm^3). CR: morphologically leukemia-free state at post-baseline visit, having neutrophil count of ≥ 1,000/mm^3 and platelet count of ≥ 100,000/mm^3, bone marrow blasts < 5%. No evidence of Auer rods & extramedullary leukemia. Blast counts in peripheral blood was ≤ 2%. | FAS | Posted | Median | 95% Confidence Interval | Months | From the date of achievement of first CRc up to the date of documented relapse or death from any cause (maximum duration: approximately 3.9 years) |
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| Secondary | Phase 2 Part: CR Rate After Consolidation and Maintenance Period | Percentage of participants with CR was reported. CR was defined as a morphologically leukemia-free state at the post-baseline visit, having a neutrophil count of ≥ 1,000/mm^3 and platelet count of ≥ 100,000/mm^3, bone marrow blasts < 5%. No evidence of Auer rods and no evidence of extramedullary leukemia. The blast counts in peripheral blood was ≤ 2%. Derived response assessment after the consolidation period refers to the best response from the start of treatment in the induction period until the end of the consolidation period and for the maintenance period refers to the best response from the start of treatment in the induction period until the end of the maintenance period. | The analysis population consisted of FAS participants, regardless of whether they proceeded to consolidation or maintenance. CR rate after consolidation included participants from induction through consolidation and CR rate after maintenance included participants from induction through maintenance. | Posted | Number | 95% Confidence Interval | Percentage of participants | CP: From date of first dose up to end of period (approximately 1.8 years), MP: From date of first dose up to the end of period (approximately 3.8 years) |
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| Secondary | Phase 2 Part: CR Rate Without Minimal Residual Disease (MRD) After Each Treatment Therapy Period | CR% without MRD reported. CR rate without MRD after each treatment therapy was defined similarly as CR rate after each treatment therapy. Responders achieve that the best response is CR and MRD status was negative. CR was defined as a morphologically leukemia-free state, having a neutrophil count of ≥ 1,000/mm^3 and platelet count of ≥ 100,000/mm^3, bone marrow blasts < 5%. No evidence of Auer rods and extramedullary leukemia. The blast counts in peripheral blood was ≤ 2%. Derived response assessment after the IP refers to the best response from the start of treatment in the IP until the end of the IP, after CP refers to the best response from the start of treatment in the IP until the end of the CP and for the MP refers to the best response from the start of treatment in the IP until the end of the MP. | The analysis population consisted of FAS participants, regardless of whether they proceeded to induction, consolidation or maintenance. CR rate after: induction included participants from start of treatment through induction; consolidation included participants from induction through consolidation and maintenance included participants from induction through maintenance. | Posted | Number | 95% Confidence Interval | Percentage of participants | IP: From date of first dose up to end of period (approximately 1.4 years), CP: From date of first dose up to end of period (approximately 1.8 years), MP: From date of first dose up to the end of period (approximately 3.8 years) |
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| Secondary | Phase 2 Part: CR With Partial Hematological Recovery (CRh) Rate After Each Treatment Therapy Period | Percentage of participants with CRh was reported. CRh was defined as a condition at the post baseline visit, having bone marrow blasts < 5%, partial hematologic recovery neutrophil count≥ 500/mm^3 and platelet count ≥ 50,000/mm^3, no evidence of extramedullary leukemia and could be classified as CR. The blast counts in peripheral blood was ≤ 2%. Derived response assessment after the IP refers to the best response from the start of treatment in the IP until the end of the IP, after CP refers to the best response from the start of treatment in the IP until the end of the CP and for the MP refers to the best response from the start of treatment in the IP until the end of the MP. | The analysis population consisted of FAS participants, regardless of whether they proceeded to induction, consolidation or maintenance. CR rate after: induction included participants from start of treatment through induction; consolidation included participants from induction through consolidation and maintenance included participants from induction through maintenance. | Posted | Number | 95% Confidence Interval | Percentage of participants | IP: From date of first dose up to end of period (approximately 1.4 years), CP: From date of first dose up to end of period (approximately 1.8 years), MP: From date of first dose up to the end of period (approximately 3.8 years) |
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| Secondary | Phase 2 Part: Composite CR (CRc) Rate After Each Treatment Therapy Period | Percentage of participants with CRc reported. CRc: rate of all complete & incomplete remissions i.e. CR + CR with incomplete platelet recovery (CRp) + CR with incomplete hematological recovery (CRi). CRp: met all CR criteria, except unrecovered platelet count (< 100,000/mm^3). CRi: met all CR criteria, except unrecovered neutrophil count (< 1,000/mm^3). CR: morphologically leukemia-free state, having neutrophil count of ≥ 1,000/mm^3 and platelet count of ≥ 100,000/mm^3, bone marrow blasts < 5%. No evidence of Auer rods & extramedullary leukemia. Blast counts in peripheral blood was ≤ 2%. Derived response assessment after the IP refers to the best response from the start of treatment in the IP until the end of the IP, after CP refers to the best response from the start of treatment in the IP until the end of the CP and for the MP refers to the best response from the start of treatment in the IP until the end of the MP. | The analysis population consisted of FAS participants, regardless of whether they proceeded to induction, consolidation or maintenance. CR rate after: induction included participants from start of treatment through induction; consolidation included participants from induction through consolidation and maintenance included participants from induction through maintenance. | Posted | Number | 95% Confidence Interval | Percentage of participants | IP: From date of first dose up to end of period (approximately 1.4 years), CP: From date of first dose up to end of period (approximately 1.8 years), MP: From date of first dose up to the end of period (approximately 3.8 years) |
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| Secondary | Phase 2 Part: CR/CRh Rate After Each Treatment Therapy Period | Percentage of participants with CR/CRh was reported. CR was defined as a morphologically leukemia-free state at the post-baseline visit, having a neutrophil count of ≥ 1,000/mm^3 and platelet count of ≥ 100,000/mm^3, bone marrow blasts < 5%. No evidence of Auer rods and no evidence of extramedullary leukemia. The blast counts in peripheral blood was ≤ 2%. CRh was defined as a condition at the post baseline visit, having bone marrow blasts < 5%, partial hematologic recovery neutrophil count≥ 500/mm^3 and platelet count ≥ 50,000/mm^3, no evidence of extramedullary leukemia and could be classified as CR. The blast counts in peripheral blood was ≤ 2%. Derived response assessment after the IP refers to the best response from the start of treatment in the IP until the end of the IP, after CP refers to the best response from the start of treatment in the IP until the end of the CP and for the MP refers to the best response from the start of treatment in the IP until the end of the MP. | The analysis population consisted of FAS participants, regardless of whether they proceeded to induction, consolidation or maintenance. CR rate after: induction included participants from start of treatment through induction; consolidation included participants from induction through consolidation and maintenance included participants from induction through maintenance. | Posted | Number | 95% Confidence Interval | Percentage of participants | IP: From date of first dose up to end of period (approximately 1.4 years), CP: From date of first dose up to end of period (approximately 1.8 years), MP: From date of first dose up to the end of period (approximately 3.8 years) |
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| Secondary | Phase 2 Part: Duration of CR | Duration of CR was defined as the time from the date of achieving first CR until the date of first documented relapse for participants who achieved CR. KM estimate was used for analysis. CR was defined as a morphologically leukemia-free state at the post-baseline visit, having a neutrophil count of ≥ 1,000/mm^3 and platelet count of ≥ 100,000/mm^3, bone marrow blasts < 5%. No evidence of Auer rods and no evidence of extramedullary leukemia. The blast counts in peripheral blood was ≤ 2%. Relapse: reappearance of leukemic blasts in peripheral blood (>2%)/≥ 5% blasts in BMA/reappearance of numbers of peripheral blasts and an increase in percentage of blasts in BMA to > 25%. | FAS with available data analyzed. | Posted | Median | 95% Confidence Interval | Months | From the date of achieving CR up to the date of documented relapse (maximum duration: approximately 2.6 years) |
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| Secondary | Phase 2 Part: Duration of CR/CRh | Duration of CR/CRh is defined as the time from the date of achieving first CR/CRh until the date of first documented relapse for participants who achieved CR/CRh. KM estimate was used for analysis. CR was defined as a morphologically leukemia-free state at the post-baseline visit, having a neutrophil count of ≥ 1,000/mm^3 and platelet count of ≥ 100,000/mm^3, bone marrow blasts < 5%. No evidence of Auer rods and no evidence of extramedullary leukemia. The blast counts in peripheral blood was ≤ 2%. CRh was defined as a condition at the post baseline visit, having bone marrow blasts < 5%, partial hematologic recovery neutrophil count≥ 500/mm^3 and platelet count ≥ 50,000/mm^3, no evidence of extramedullary leukemia and could be classified as CR. The blast counts in peripheral blood was ≤ 2%. Relapse: reappearance of leukemic blasts in peripheral blood (>2%)/≥ 5% blasts in BMA/reappearance of numbers of peripheral blasts and an increase in percentage of blasts in BMA to > 25%. | FAS with available data analyzed. | Posted | Median | 95% Confidence Interval | Months | From the date of achieving CR/CRh up to the date of documented relapse (maximum duration: approximately 2.6 years) |
| |||||||||||||||||||||||||||
| Secondary | Phase 2 Part: Duration of CRh | Duration of CRh was defined as the time from date of achieving first CRh until date of first documented relapse for participants who achieved CRh. KM estimate was used for analysis. CRh was defined as a condition at the post baseline visit, having bone marrow blasts < 5%, partial hematologic recovery neutrophil count≥ 500/mm^3 and platelet count ≥ 50,000/mm^3, no evidence of extramedullary leukemia and could be classified as CR. The blast counts in peripheral blood was ≤ 2%. Relapse: reappearance of leukemic blasts in peripheral blood (>2%)/≥ 5% blasts in BMA/reappearance of numbers of peripheral blasts and an increase in percentage of blasts in BMA to > 25%. | FAS with available data analyzed. | Posted | Median | 95% Confidence Interval | Months | From the date of achieving CRh up to the date of documented relapse (maximum duration: approximately 2.6 years) |
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| Secondary | Phase 2 Part: Duration of CRc | Duration of CRc is defined as the time from the date of achieving first CRc until the date of first documented relapse for participants who achieved CRc. KM estimate was used for analysis. CRc: rate of all complete & incomplete remissions i.e. CR + CR with incomplete platelet recovery (CRp) + CR with incomplete hematological recover (CRi). CRp: met all CR criteria at post-baseline visit, except unrecovered platelet count (< 100,000/mm^3). CRi: met all CR criteria at post-baseline visit, except unrecovered neutrophil count (< 1,000/mm^3). CR: morphologically leukemia-free state at post-baseline visit, having neutrophil count of ≥ 1,000/mm^3 and platelet count of ≥ 100,000/mm^3, bone marrow blasts < 5%. No evidence of Auer rods & extramedullary leukemia. Blast counts in peripheral blood was ≤ 2%. Relapse: reappearance of leukemic blasts in peripheral blood (>2%)/≥ 5% blasts in BMA/reappearance of numbers of peripheral blasts and an increase in percentage of blasts in BMA to > 25%. | FAS with available data analyzed. | Posted | Median | 95% Confidence Interval | Months | From the date of achieving CRc up to the date of documented relapse (maximum duration: approximately 2.7 years) |
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| Secondary | Phase 2 Part: Duration of Response (DoR) | DoR: from first day of achieving CRc (CR+ CRp,+CRi)/partial remission (PR) to first day of relapse. KM estimate was used for analysis. CR: morphologically leukemia-free state at post-baseline visit, having neutrophil count of ≥ 1,000/mm^3 & platelet count of ≥ 100,000/mm^3, bone marrow blasts < 5%. No evidence of Auer rods & extramedullary leukemia. Peripheral blood blast counts was ≤ 2%. CRp: met all CR criteria at post-baseline visit, except unrecovered platelet count (< 100,000/mm^3). CRi: met all CR criteria at post-baseline visit, except unrecovered neutrophil count (< 1,000/mm^3). PR: condition with regeneration of normal hematopoietic cells in bone marrow, no detectable blasts, ≥ 50% decrease of blasts in BMA & total bone marrow blasts of 5-25%. No evidence of extramedullary leukemia. Relapse: reappearance of leukemic blasts in peripheral blood (>2%)/≥ 5% blasts in BMA/reappearance of numbers of peripheral blasts and an increase in percentage of blasts in BMA to > 25% | FAS with available data analyzed. | Posted | Median | 95% Confidence Interval | Months | From the date of achieving CR, CRp, CRi/PR up to the date of documented relapse (maximum duration: approximately 2.7 years) |
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| Secondary | Phase 2 Part: Number of Participants With Treatment Emergent Adverse Events (TEAEs) | An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE could therefore be any unfavorable & unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. TEAE for Phase 2 was defined as an AE observed after the date of first dose until 30 days after the last dose. TEAE included both serious and non-serious AEs. | SAF | Posted | Number | Participants | From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) |
|
Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase 1: Dose Evaluation (DEv) | Induction period (IP): Participants received 120 milligrams (mg) giltertinib (3 tablets of 40 mg) orally, once a day from days 4 to 17 in combination with chemotherapy (idarubicin: 12 milligrams per square meters per day [mg/m^2/day] on days 1 to 3, cytarabine: 100 mg/m^2/day on days 1 to 7) via intravenous (IV) infusion; in the induction period in cycles (C) 1 and 2 (1 cycle= 42 days). Duration of infusion was determined based on site clinical practice and the local package insert. Consolidation period (CP): Participants received 120 mg giltertinib (3 tablets of 40 mg) orally, once a day from days 1 to 14 in combination with chemotherapy (cytarabine: 1500 mg/m^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3 (1 cycle= 28 days). Duration of infusion was determined based on site clinical practice and the local package insert. Maintenance period (MP): Participants received 120 mg giltertinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days). | 0 | 3 | 2 | 3 | 3 | 3 |
| EG001 | Phase 1: Dose Expansion (DEx) | Induction period (IP): Participants received 120 mg giltertinib (3 tablets of 40 mg) orally, once a day from days 4 to 17 in combination with chemotherapy (idarubicin: 12 mg/m^2/day on days 1 to 3, cytarabine: 100 mg/m^2/day on days 1 to 7) via IV infusion; in the induction period in C1 and 2 (1 cycle= 42 days). Duration of infusion was determined based on site clinical practice and the local package insert. Consolidation period (CP): Participants received 120 mg giltertinib (3 tablets of 40 mg) orally, once a day from days 1 to 14 in combination with chemotherapy (cytarabine: 1500 mg/m^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3 (1 cycle= 28 days). Duration of infusion was determined based on site clinical practice and the local package insert. Maintenance period (MP): Participants received 120 mg giltertinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days). | 0 | 10 | 1 | 10 | 10 | 10 |
| EG002 | Phase 2: FLT3-mutated AML | Induction period (IP): Participants received 120 mg giltertinib (3 tablets of 40 mg) orally, once a day from days 8 until blood recovery in combination with chemotherapy (idarubicin: 12 mg/m^2/day on days 1 to 3, cytarabine: 100 mg/m^2/day on days 1 to 7) via IV infusion; in the induction period in C1 and 2. Each cycle was allowed to be extended until blood recovery was observed. Duration of infusion was determined based on site clinical practice and the local package insert. Consolidation period (CP): Participants received 120 mg giltertinib (3 tablets of 40 mg) orally, once a day from days 1 until blood recovery in combination with chemotherapy (cytarabine: 1500 mg/m^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3. Each cycle was allowed to be extended until blood recovery was observed. Duration of infusion was determined based on site clinical practice and the local package insert. Maintenance period (MP): Participants received 120 mg giltertinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days). | 25 | 84 | 45 | 84 | 84 | 84 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Stress cardiomyopathy | Cardiac disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Acute graft versus host disease | Immune system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Graft versus host disease | Immune system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| Bacterial sepsis | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| Brain abscess | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| Klebsiella sepsis | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| Liver abscess | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| Meningitis | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| Root canal infection | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| Splenic abscess | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA v23.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA v23.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA v23.0 | Systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA v23.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA v23.0 | Systematic Assessment |
| |
| Neuroendocrine tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | Systematic Assessment |
| |
| Brain stem infarction | Nervous system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Tubulointerstitial nephritis | Renal and urinary disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Cervical dysplasia | Reproductive system and breast disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Acquired antithrombin III deficiency | Blood and lymphatic system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Thrombotic microangiopathy | Blood and lymphatic system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Corneal perforation | Eye disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Mucosal disorder | General disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Chronic graft versus host disease | Immune system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Hypogammaglobulinaemia | Immune system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| Pneumonia fungal | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| Prostate infection | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| Electrocardiogram ST segment elevation | Investigations | MedDRA v23.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Steroid diabetes | Metabolism and nutrition disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA v23.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Thyroiditis chronic | Endocrine disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Aphthous ulcer | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Periodontal disease | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Proctitis | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Infusion site rash | General disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Hypogammaglobulinaemia | Immune system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| Cytomegalovirus infection | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| Enterococcal bacteraemia | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| Gingivitis | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| Pseudomembranous colitis | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| Allergic transfusion reaction | Injury, poisoning and procedural complications | MedDRA v23.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA v23.0 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA v23.0 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA v23.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA v23.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA v23.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA v23.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA v23.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA v23.0 | Systematic Assessment |
| |
| Body temperature increased | Investigations | MedDRA v23.0 | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA v23.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA v23.0 | Systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA v23.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA v23.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA v23.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA v23.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA v23.0 | Systematic Assessment |
| |
| Alkalosis | Metabolism and nutrition disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Purpura | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Vasculitis | Vascular disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Myelosuppression | Blood and lymphatic system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Anal haemorrhage | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Graft versus host disease | Immune system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| Pneumonia fungal | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Systematic Assessment |
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Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript prior to publication for review and comment as specified in the Investigator Agreement.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Transparency | Astellas Pharma Inc. | 800-888-7704 | astellas.resultsdisclosure@astellas.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 16, 2021 | Jul 3, 2025 | SAP_003.pdf |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000609080 | gilteritinib |
| D015255 | Idarubicin |
| D003561 | Cytarabine |
| ID | Term |
|---|---|
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
Not provided
Not provided
| There is no CR, CRp, or CRi after 2 Cycles of Therapy |
|
| Disease Relapse |
|
| Physician Decision |
|
| Withdrawal by Subject |
|
| Lack of Efficacy |
|
| Death |
|
| Adverse Event |
|
| Physician Decision |
|
| Adverse Event |
|
| Death |
|
| Physician Decision |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Units | Counts |
|---|
| Participants |
|
|
| OG001 | Phase 1: Dose Expansion (DEx) | Induction period: Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 4 to 17 in combination with chemotherapy (idarubicin: 12 mg/m^2/day on days 1 to 3, cytarabine: 100 mg/m^2/day on days 1 to 7) via IV infusion; in the induction period in C1 and 2 (1 cycle= 42 days). Duration of infusion was determined based on site clinical practice and the local package insert. Consolidation period: Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 14 in combination with chemotherapy (cytarabine: 1500 mg/m^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3 (1 cycle= 28 days). Duration of infusion was determined based on site clinical practice and the local package insert. Maintenance period: Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days). |
|
|
| OG001 | Phase 1: Dose Expansion (DEx) | Induction period: Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 4 to 17 in combination with chemotherapy (idarubicin: 12 mg/m^2/day on days 1 to 3, cytarabine: 100 mg/m^2/day on days 1 to 7) via IV infusion; in the induction period in C1 and 2 (1 cycle= 42 days). Duration of infusion was determined based on site clinical practice and the local package insert. Consolidation period: Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 14 in combination with chemotherapy (cytarabine: 1500 mg/m^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3 (1 cycle= 28 days). Duration of infusion was determined based on site clinical practice and the local package insert. Maintenance period: Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days). |
|
|
|
|
| OG001 | Phase 1: Dose Expansion (DEx) | Induction period: Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 4 to 17 in combination with chemotherapy (idarubicin: 12 mg/m^2/day on days 1 to 3, cytarabine: 100 mg/m^2/day on days 1 to 7) via IV infusion; in the induction period in C1 and 2 (1 cycle= 42 days). Duration of infusion was determined based on site clinical practice and the local package insert. Consolidation period: Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 14 in combination with chemotherapy (cytarabine: 1500 mg/m^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3 (1 cycle= 28 days). Duration of infusion was determined based on site clinical practice and the local package insert. Maintenance period: Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days). |
|
|
Induction period: Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 4 to 17 in combination with chemotherapy (idarubicin: 12 mg/m^2/day on days 1 to 3, cytarabine: 100 mg/m^2/day on days 1 to 7) via IV infusion; in the induction period in C1 and 2 (1 cycle= 42 days). Duration of infusion was determined based on site clinical practice and the local package insert. Consolidation period: Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 14 in combination with chemotherapy (cytarabine: 1500 mg/m^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3 (1 cycle= 28 days). Duration of infusion was determined based on site clinical practice and the local package insert. Maintenance period: Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days). |
|
|
| OG001 | Phase 1: Dose Expansion (DEx) | Induction period: Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 4 to 17 in combination with chemotherapy (idarubicin: 12 mg/m^2/day on days 1 to 3, cytarabine: 100 mg/m^2/day on days 1 to 7) via IV infusion; in the induction period in C1 and 2 (1 cycle= 42 days). Duration of infusion was determined based on site clinical practice and the local package insert. Consolidation period: Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 14 in combination with chemotherapy (cytarabine: 1500 mg/m^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3 (1 cycle= 28 days). Duration of infusion was determined based on site clinical practice and the local package insert. Maintenance period: Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days). |
|
|
| OG001 | Phase 1: Dose Expansion (DEx) | Induction period: Participants received 120 mg giltertinib (3 tablets of 40 mg) orally, once a day from days 4 to 17 in combination with chemotherapy (idarubicin: 12 mg/m^2/day on days 1 to 3, cytarabine: 100 mg/m^2/day on days 1 to 7) via IV infusion; in the induction period in C1 and 2 (1 cycle= 42 days). Duration of infusion was determined based on site clinical practice and the local package insert. Consolidation period: Participants received 120 mg giltertinib (3 tablets of 40 mg) orally, once a day from days 1 to 14 in combination with chemotherapy (cytarabine: 1500 mg/m^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3 (1 cycle= 28 days). Duration of infusion was determined based on site clinical practice and the local package insert. Maintenance period: Participants received 120 mg giltertinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days). |
|
|
| Phase 1: Dose Expansion (DEx) |
Induction period: Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 4 to 17 in combination with chemotherapy (idarubicin: 12 mg/m^2/day on days 1 to 3, cytarabine: 100 mg/m^2/day on days 1 to 7) via IV infusion; in the induction period in C1 and 2 (1 cycle= 42 days). Duration of infusion was determined based on site clinical practice and the local package insert. Consolidation period: Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 14 in combination with chemotherapy (cytarabine: 1500 mg/m^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3 (1 cycle= 28 days). Duration of infusion was determined based on site clinical practice and the local package insert. Maintenance period: Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days). |
|
|
| Phase 1: Dose Expansion (DEx) |
Induction period: Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 4 to 17 in combination with chemotherapy (idarubicin: 12 mg/m^2/day on days 1 to 3, cytarabine: 100 mg/m^2/day on days 1 to 7) via IV infusion; in the induction period in C1 and 2 (1 cycle= 42 days). Duration of infusion was determined based on site clinical practice and the local package insert. Consolidation period: Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 14 in combination with chemotherapy (cytarabine: 1500 mg/m^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3 (1 cycle= 28 days). Duration of infusion was determined based on site clinical practice and the local package insert. Maintenance period: Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days). |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Induction period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 8 until blood recovery in combination with chemotherapy (idarubicin: 12 mg/m^2/day on days 1 to 3, cytarabine: 100 mg/m^2/day on days 1 to 7) via IV infusion; in the induction period in C1 and 2. Each cycle was allowed to be extended until blood recovery was observed. Duration of infusion was determined based on site clinical practice and the local package insert.
Consolidation period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 until blood recovery in combination with chemotherapy (cytarabine: 1500 mg/m^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3. Each cycle was allowed to be extended until blood recovery was observed. Duration of infusion was determined based on site clinical practice and the local package insert.
Maintenance period:
Participants received 120 mg giltertinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days).
|
|
Induction period: Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 8 until blood recovery in combination with chemotherapy (idarubicin: 12 mg/m^2/day on days 1 to 3, cytarabine: 100 mg/m^2/day on days 1 to 7) via IV infusion; in the induction period in C1 and 2. Each cycle was allowed to be extended until blood recovery was observed. Duration of infusion was determined based on site clinical practice and the local package insert. Consolidation period: Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 until blood recovery in combination with chemotherapy (cytarabine: 1500 mg/m^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3. Each cycle was allowed to be extended until blood recovery was observed. Duration of infusion was determined based on site clinical practice and the local package insert. Maintenance period: Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days). |
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