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The purpose of this study was to determine the safety and tolerability of gilteritinib given in combination with atezolizumab in participants with relapsed or treatment refractory FMS-like tyrosine kinase 3 (FLT3) mutated AML and to determine the composite complete remission (CRc) rate for participants who either discontinued the study or completed 2 cycles of gilteritinib given in combination with atezolizumab.
This study also evaluated pharmacokinetics (PK), response to treatment, remission and survival. Adverse events (AEs), clinical laboratory results, vital signs, electrocardiograms (ECGs), and Eastern Cooperative Oncology Group (ECOG) performance status scores were also assessed.
This study was planned to have 2 phases:
Phase 1:
The phase 1 portion of this study was to establish the recommended phase 2 dose (RP2D) of gilteritinib given in combination with atezolizumab.
Phase 2:
The phase 2 portion of the study was to treat participants with gilteritinib and atezolizumab at the RP2D and was to be enrolled in two stages. The first stage was to evaluate the remission rate and if a minimum rate was to be achieved, a second stage of enrollment was to be continued.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gilteritinib 120 mg + Atezolizumab 420 mg | Experimental | Participants received 120 milligrams (mg) giltertinib (3 tablets of 40 mg) orally, once a day in continuous 28-day cycles in combination with atezolizumab 420 mg adminstered by intravenous infusion (over 60 minutes) once every 2 weeks of 28-day cycle until the participant no longer received clinical benefit from therapy, unacceptable toxicity occurred or the participant met a treatment discontinuation criterion (Maximum treatment duration was 535 days for gilteritinib and 112 days for atezolizumab). |
|
| Gilteritinib 120 mg + Atezolizumab 840 mg | Experimental | Participants received 120 mg giltertinib (3 tablets of 40 mg) orally, once a day in continuous 28-day cycles in combination with atezolizumab 840 mg administered by intravenous infusion (over 60 minutes) once every 2 weeks of 28-day cycle until the participant no longer received clinical benefit from therapy, unacceptable toxicity occurred or the participant met a treatment discontinuation criterion (Maximum treatment duration was 126 days for gilteritinib and 70 days for atezolizumab). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gilteritinib | Drug | Oral tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Dose Limiting Toxicities (DLT) | DLTs were defined as:
| Day 1 up to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Composite Complete Remission (CRc) Rate | CRc was defined as rate of all complete and incomplete remissions i.e. CR + CR with incomplete platelet recovery (CRp) + CR with incomplete hematological recover (CRi). Participants were classified as: CR if they achieved morphologic leukemia-free state & their bone marrow was regenerating normal hematopoietic cells. If they had absolute neutrophil count (ANC) > 1 × 10^9/L, platelet count ≥ 100 × 10^9/L, normal marrow differential < 5% blasts, & were red blood cell (RBC) and platelet transfusion independent (defined as 1 week without RBC transfusion and platelet transfusion prior to disease assessment). There was also no evidence of extramedullary leukemia. CRp if they achieved CR with incomplete platelet recovery (< 100 × 10^9/L). CRi if they achieved CR with incomplete hematological recovery with residual neutropenia < 1 × 10^9/L, with or without complete platelet recovery. RBC and platelet transfusion independence was not required. Percentage of participants with CRc was reported. |
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Inclusion Criteria:
Subject is considered an adult according to local regulation at the time of signing informed consent form (ICF).
Subject has defined AML by the World Health Organization (WHO) criteria (2017) and fulfills one of the following:
Subject is positive for FLT3 mutation in bone marrow or blood after completion of the subject's last interventional treatment.
Subject has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 at screening.
Subject must meet the following criteria as indicated on the clinical laboratory tests:
Subject is suitable for oral administration of study drug.
A female subject is eligible to participate if she is not pregnant and at least one of the following conditions applies:
Female subject must agree not to breastfeed starting at screening and throughout the study period, and for at least 180 days after the final study drug administration.
Female subject must not donate ova starting at screening and throughout the study period, and for at least 180 days after the final study drug administration.
A male subject must not donate sperm starting at screening and throughout the treatment period, and for at least 120 days after the final study drug administration.
A male subject with female partner(s) of child-bearing potential must agree to use contraception during the treatment period, and for at least 120 days after the final study drug administration.
Male subject with a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy or time partner is breastfeeding throughout the treatment period, and for 120 days after the final study drug administration.
Subject agrees not to participate in another investigational study while on treatment.
Exclusion Criteria:
Subject was diagnosed as acute promyelocytic leukemia.
Subject has BCR-ABL-positive leukemia (chronic myelogenous leukemia in blast crisis).
Subject has AML secondary to prior chemotherapy for other neoplasms (except for myelodysplastic syndrome).
Subject has clinically active central nervous system leukemia.
Subject has uncontrolled or significant cardiovascular disease, including:
Subject has baseline left ventricular ejection fraction that is ≥ 45%.
Subject has mean triplicate Fridericia-corrected QT interval (QTcF) > 450 ms at Screening based on central reading.
Subject has congenital or acquired Long QT Syndrome at screening.
Subject has hypokalemia and/or hypomagnesemia at screening.
Subject has been diagnosed with another malignancy that requires concurrent treatment or hepatic malignancy regardless of the need for treatment.
Subject has clinically significant coagulation abnormality unless secondary to AML.
Subject is receiving or plans to receive concomitant chemotherapy or immunotherapy.
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 requires treatment with concomitant drugs that are strong inducers of Cytochrome P450 (CYP3A).
Subject has known pulmonary disease with diffusion capacity of lung for carbon monoxide ≤ 65%, forced expiratory volume in the first second (FEV1) ≤ 65%, dyspnea at rest or requiring oxygen or any pleural neoplasm.
Subject with systemic fungal, bacterial, viral or other uncontrolled infection that is exhibiting ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics or other treatment. Subject needs to be off pressors and have negative blood cultures for 48 hours.
Subject has not recovered from any prior therapy related toxicities.
Subject is known to have human immunodeficiency virus infection.
Subject has active hepatitis B or C or other active hepatic disorder.
Subject has previously been treated with gilteritinib, quizartinib or crenolanib (will only apply to subjects enrolled in the phase 2 portion of the study).
Subject has active clinically significant graft-versus-host disease (GVHD) or is on treatment with systemic corticosteroids for GVHD.
Subject has relapsed after allogeneic hematopoietic stem cell transplant (HCST).
Subject has an active autoimmune disorder that makes the subject unsuitable for study treatment or participation.
Subject has any condition that makes the subject unsuitable for study participation.
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| Name | Affiliation | Role |
|---|---|---|
| Executive Medical Director | Astellas Pharma Global Development | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ronald Reagan UCLA Medical Center | Los Angeles | California | 90095 | United States | ||
| University of Chicago |
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| Label | URL |
|---|---|
| Link to results on the Astellas Clinical Study Results website. | View source |
| Link to plain language summary of the study on the Trial Results Summaries website | View source |
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Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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Participants with relapsed or treatment refractory FMS-like tyrosine kinase 3 (FLT3) mutated acute myeloid leukemia (AML) were enrolled in this study.
Study was planned for two phases, dose-escalation (phase 1) and dose expansion (phase 2). Sponsor decided not to open the phase 2 extension part of the study after completion of phase 1 dose escalation part.
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| ID | Title | Description |
|---|---|---|
| FG000 | Gilteritinib 120 mg + Atezolizumab 420 mg | Participants received 120 mg (milligrams) giltertinib (3 tablets of 40 mg) orally, once a day in continuous 28-day cycles in combination with atezolizumab 420 mg adminstered by intravenous infusion (over 60 minutes) once every 2 weeks of 28-day cycle until the participant no longer received clinical benefit from therapy, unacceptable toxicity occurred or the participant met a treatment discontinuation criterion (Maximum treatment duration was 535 days for gilteritinib and 112 days for atezolizumab). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Dec 9, 2020 | May 3, 2022 |
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| atezolizumab | Drug | Intravenous infusion |
|
| From the date of first dose up to end of treatment (Maximum treatment duration was 535 days for gilteritinib and 112 days for atezolizumab) |
| Plasma Ctrough Concentration of Gilteritinib | Plasma Ctrough concentrations of gilteritinib was reported. One cycle = 28 days. C= cycle, D=day | Pre-dose on C1D1, C1D8, C1D15, C2D1,C2D15, C3D1, C3D15, C4D1, C4D15, C5D1, C5D15, C6D1, C6D15 |
| Complete Remission (CR) Rate | Participants were classified as CR if they achieved a morphologic leukemia-free state and their bone marrow was regenerating normal hematopoietic cells. In addition, these participants had ANC > 1 × 10^9/L, platelet count ≥ 100 × 10^9/L, normal marrow differential with < 5% blasts, and were RBC and platelet transfusion independent (defined as 1 week without RBC transfusion and 1 week without platelet transfusion prior to disease assessment). There was also no evidence of extramedullary leukemia. CR rate was defined as the number of participants with CR divided by the number of participants in the analysis population. Percentage of participants with CR was reported. | From the date of first dose up to end of treatment (Maximum treatment duration was 535 days for gilteritinib and 112 days for atezolizumab) |
| Complete Remission With Partial Hematologic Recovery (CRh) Rate | Participants were classified as CRh if they achieved CR with ANC level of > 0.5 × 10^9/L and platelet count of > 50 × 10^9/L. CRh rate was defined as the number of participants with CRh divided by the number of participants in the analysis population. Participants were classified as CR if they achieved a morphologic leukemia-free state and their bone marrow was regenerating normal hematopoietic cells. In addition, these participants had ANC > 1 × 10^9/L, platelet count ≥ 100 × 10^9/L, normal marrow differential with < 5% blasts, and were RBC and platelet transfusion independent (defined as 1 week without RBC transfusion and 1 week without platelet transfusion prior to disease assessment). There was also no evidence of extramedullary leukemia. Percentage of participants with CRh was reported. | From the date of first dose up to end of treatment (Maximum treatment duration was 535 days for gilteritinib and 112 days for atezolizumab) |
| Best Response Rate | Best response was defined as the best-measured response (CR, CRp, CRi or PR) post-treatment. Best response rate was defined as the number of participants with CR or CRp or CRi or PR divided by the number of participants in the analysis population (i.e., CR+ CRp + CRi + PR). Participants with unknown or missing response, or who provide no information on response at the end of study will be treated as non-responders and will be included in the denominator when calculating rates. CR, CRp and CRi were described in outcome measure 2#. Participants were classified as PR if their bone marrow was regenerating normal hematopoietic cells with evidence of peripheral recovery with no (or only a few regenerating) circulating blasts and a decrease of at least 50% in the percentage of blasts in the bone marrow aspirate/biopsy, with the total marrow blasts between 5% and 25%. Percentage of participants with best response was reported. | From the date of first dose up to end of treatment (Maximum treatment duration was 535 days for gilteritinib and 112 days for atezolizumab) |
| Duration of Remission (DoR) | DoR: duration of CRc, CR, CRi, CRp & response (CRc + PR). Duration of CRc/CR/CRi/CRp: time from date of first CRc/CR/CRi/CRp until date of documented relapse for participants who achieved CRc/CR/CRi/CRp. Duration of response: time from date of either first CRc or PR until date of documented relapse of any type for participants who achieved CRc or PR. CRc, CR, CRi, CRp were described in outcome measure #2 & PR was described in outcome measure #6. Relapse after CR, CRp or CRi: reappearance of leukemic blasts in peripheral blood or ≥ 5% blasts in bone marrow aspirate/biopsy not attributable to any other cause or reappearance or new appearance of extramedullary leukemia. Relapse after PR: reappearance of significant numbers of peripheral blasts & an increase in the percentage of blasts in the bone marrow aspirate/biopsy to > 25% not attributable to any other cause or reappearance or new appearance of extramedullary leukemia. Analysis was performed using Kaplan-Meier estimates. | From date of first response until the date of documented relapse (Maximum treatment duration was 535 days for gilteritinib and 112 days for atezolizumab) |
| Event Free Survival (EFS) | EFS was defined as time from date of first dose until date of documented relapse from CR, CRp or CRi, treatment failure or death from any cause, whichever occurred first. CRc, CR, CRi, CRp were described in Outcome measure #2. For a participant with none of these events, EFS was censored at date of last disease assessment. Relapse after CR, CRp or CRi was defined as reappearance of leukemic blasts in peripheral blood or ≥ 5% blasts in bone marrow aspirate/biopsy not attributable to any other cause or reappearance or new appearance of extramedullary leukemia. Relapse after PR was defined with reappearance of significant numbers of peripheral blasts & an increase in the percentage of blasts in the bone marrow aspirate/biopsy to > 25% not attributable to any other cause or reappearance or new appearance of extramedullary leukemia. Treatment failure was defined as lack of CR, CRp or CRi, & was determined at the end of treatment (EoT). Analysis was performed using Kaplan-Meier estimates. | From the date of first dose until the date of documented relapse from CR, CRp or CRi, treatment failure or death from any cause, whichever occurred first (Maximum treatment duration was 535 days for gilteritinib and 112 days for atezolizumab) |
| Overall Survival (OS) | OS was defined as the time from the date of first dose until the date of death from any cause. For a participant who was not known to have died by the end of study follow-up, overall survival was censored at the date of last contact. Analysis was performed using Kaplan-Meier estimates. | From the date of first dose until the date of death from any cause (Maximum treatment duration was 535 days for gilteritinib and 112 days for atezolizumab) |
| Number of Participants With Treatment-Emergent Adverse Events | An AE was any untoward medical occurrence in a participant administered study drug, & which did not necessarily have to have a causal relationship with this treatment. Abnormalities was defined as AE only if met 1 of the criteria:Induced clinical signs/symptoms, required active intervention, required interruption or discontinuation of ST, abnormality or investigational value was clinically significant. Serious AE:resulted in death, was life threatening, persistent or significant disability/incapacity or substantial disruption of ability to conduct normal life functions, congenital anomaly/birth defect, required hospitalization or prolongation of hospitalization, other medically important events. Any AE recorded on treatment including within 30 days from last study treatment was classified as treatment-emergent AE (TEAE). Grades(Gr) based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) (Gr 1=mild, Gr 2=moderate, Gr 3 =severe, Gr 4 =life threatening, Gr 5 =death). | Baseline to 30 days after last study treatment (Maximum treatment duration was 535 days for gilteritinib and 112 days for atezolizumab) |
| Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Score | ECOG performance status was measured on an 6 point scale. 0-Fully active, able to carry on all pre-disease performance without restriction.
| Baseline and end of treatment (EoT) (Maximum treatment duration was 535 days for gilteritinib and 112 days for atezolizumab) |
| Chicago |
| Illinois |
| 60037 |
| United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| University of Kentucky | Lexington | Kentucky | 40536 | United States |
| Roswell Park Cancer Institute (RPCI) | Buffalo | New York | 14263 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Weill Cornell Medical College | New York | New York | 10065 | United States |
| The Ohio State University Comprehensive Cancer Center (OSUCCC) | Columbus | Ohio | 43210 | United States |
| Vanderbilt Ingram Cancer Center | Nashville | Tennessee | 37232 | United States |
| Simmons Comprehensive Cancer Center | Dallas | Texas | 75390 | United States |
| University of Texas MD Anderson | Houston | Texas | 77030 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| FG001 | Gilteritinib 120 mg + Atezolizumab 840 mg | Participants received 120 mg giltertinib (3 tablets of 40 mg) orally, once a day in continuous 28-day cycles in combination with atezolizumab 840 mg adminstered by intravenous infusion (over 60 minutes) once every 2 weeks of 28-day cycle until the participant no longer received clinical benefit from therapy, unacceptable toxicity occurred or the participant met a treatment discontinuation criterion (Maximum treatment duration was 126 days for gilteritinib and 70 days for atezolizumab). |
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| NOT COMPLETED |
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The safety analysis set consisted of all participants who took at least 1 dose of study drug (gilteritinib or atezolizumab).
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| ID | Title | Description |
|---|---|---|
| BG000 | Gilteritinib 120 mg + Atezolizumab 420 mg | Participants received 120 mg giltertinib (3 tablets of 40 mg) orally, once a day in continuous 28-day cycles in combination with atezolizumab 420 mg adminstered by intravenous infusion (over 60 minutes) once every 2 weeks of 28-day cycle until the participant no longer received clinical benefit from therapy, unacceptable toxicity occurred or the participant met a treatment discontinuation criterion (Maximum treatment duration was 535 days for gilteritinib and 112 days for atezolizumab). |
| BG001 | Gilteritinib 120 mg + Atezolizumab 840 mg | Participants received 120 mg giltertinib (3 tablets of 40 mg) orally, once a day in continuous 28-day cycles in combination with atezolizumab 840 mg adminstered by intravenous infusion (over 60 minutes) once every 2 weeks of 28-day cycle until the participant no longer received clinical benefit from therapy, unacceptable toxicity occurred or the participant met a treatment discontinuation criterion (Maximum treatment duration was 126 days for gilteritinib and 70 days for atezolizumab). |
| BG002 | 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 | |||||||||||||||||||||||
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| Primary | Number of Participants With Dose Limiting Toxicities (DLT) | DLTs were defined as:
| Safety Population | Posted | Number | Participants | Day 1 up to 28 days |
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| Secondary | Composite Complete Remission (CRc) Rate | CRc was defined as rate of all complete and incomplete remissions i.e. CR + CR with incomplete platelet recovery (CRp) + CR with incomplete hematological recover (CRi). Participants were classified as: CR if they achieved morphologic leukemia-free state & their bone marrow was regenerating normal hematopoietic cells. If they had absolute neutrophil count (ANC) > 1 × 10^9/L, platelet count ≥ 100 × 10^9/L, normal marrow differential < 5% blasts, & were red blood cell (RBC) and platelet transfusion independent (defined as 1 week without RBC transfusion and platelet transfusion prior to disease assessment). There was also no evidence of extramedullary leukemia. CRp if they achieved CR with incomplete platelet recovery (< 100 × 10^9/L). CRi if they achieved CR with incomplete hematological recovery with residual neutropenia < 1 × 10^9/L, with or without complete platelet recovery. RBC and platelet transfusion independence was not required. Percentage of participants with CRc was reported. | The full analysis set (FAS) consisted of all participants who were enrolled in the study and took at least 1 dose of study drug (gilteritinib or atezolizumab). | Posted | Number | 95% Confidence Interval | Percentage of participants | From the date of first dose up to end of treatment (Maximum treatment duration was 535 days for gilteritinib and 112 days for atezolizumab) |
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| Secondary | Plasma Ctrough Concentration of Gilteritinib | Plasma Ctrough concentrations of gilteritinib was reported. One cycle = 28 days. C= cycle, D=day | The pharmacokinetic analysis set (PKAS) consisted of the administered population for which sufficient plasma concentration data was available to facilitate derivation of at least 1 PK parameter and for whom at least 1 plasma concentration datum was available and both the date and time of dosing on the day of PK sampling and the date and time of sampling were known. Participants with available data at specified time point were included. | Posted | Mean | Standard Deviation | Nanogram per milliliter | Pre-dose on C1D1, C1D8, C1D15, C2D1,C2D15, C3D1, C3D15, C4D1, C4D15, C5D1, C5D15, C6D1, C6D15 |
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| Secondary | Complete Remission (CR) Rate | Participants were classified as CR if they achieved a morphologic leukemia-free state and their bone marrow was regenerating normal hematopoietic cells. In addition, these participants had ANC > 1 × 10^9/L, platelet count ≥ 100 × 10^9/L, normal marrow differential with < 5% blasts, and were RBC and platelet transfusion independent (defined as 1 week without RBC transfusion and 1 week without platelet transfusion prior to disease assessment). There was also no evidence of extramedullary leukemia. CR rate was defined as the number of participants with CR divided by the number of participants in the analysis population. Percentage of participants with CR was reported. | FAS Population | Posted | Number | 95% Confidence Interval | Percentage of participants | From the date of first dose up to end of treatment (Maximum treatment duration was 535 days for gilteritinib and 112 days for atezolizumab) |
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| Secondary | Complete Remission With Partial Hematologic Recovery (CRh) Rate | Participants were classified as CRh if they achieved CR with ANC level of > 0.5 × 10^9/L and platelet count of > 50 × 10^9/L. CRh rate was defined as the number of participants with CRh divided by the number of participants in the analysis population. Participants were classified as CR if they achieved a morphologic leukemia-free state and their bone marrow was regenerating normal hematopoietic cells. In addition, these participants had ANC > 1 × 10^9/L, platelet count ≥ 100 × 10^9/L, normal marrow differential with < 5% blasts, and were RBC and platelet transfusion independent (defined as 1 week without RBC transfusion and 1 week without platelet transfusion prior to disease assessment). There was also no evidence of extramedullary leukemia. Percentage of participants with CRh was reported. | FAS Population | Posted | Number | 95% Confidence Interval | Percentage of participants | From the date of first dose up to end of treatment (Maximum treatment duration was 535 days for gilteritinib and 112 days for atezolizumab) |
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| Secondary | Best Response Rate | Best response was defined as the best-measured response (CR, CRp, CRi or PR) post-treatment. Best response rate was defined as the number of participants with CR or CRp or CRi or PR divided by the number of participants in the analysis population (i.e., CR+ CRp + CRi + PR). Participants with unknown or missing response, or who provide no information on response at the end of study will be treated as non-responders and will be included in the denominator when calculating rates. CR, CRp and CRi were described in outcome measure 2#. Participants were classified as PR if their bone marrow was regenerating normal hematopoietic cells with evidence of peripheral recovery with no (or only a few regenerating) circulating blasts and a decrease of at least 50% in the percentage of blasts in the bone marrow aspirate/biopsy, with the total marrow blasts between 5% and 25%. Percentage of participants with best response was reported. | FAS Population | Posted | Number | 95% Confidence Interval | Percentage of participants | From the date of first dose up to end of treatment (Maximum treatment duration was 535 days for gilteritinib and 112 days for atezolizumab) |
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| Secondary | Duration of Remission (DoR) | DoR: duration of CRc, CR, CRi, CRp & response (CRc + PR). Duration of CRc/CR/CRi/CRp: time from date of first CRc/CR/CRi/CRp until date of documented relapse for participants who achieved CRc/CR/CRi/CRp. Duration of response: time from date of either first CRc or PR until date of documented relapse of any type for participants who achieved CRc or PR. CRc, CR, CRi, CRp were described in outcome measure #2 & PR was described in outcome measure #6. Relapse after CR, CRp or CRi: reappearance of leukemic blasts in peripheral blood or ≥ 5% blasts in bone marrow aspirate/biopsy not attributable to any other cause or reappearance or new appearance of extramedullary leukemia. Relapse after PR: reappearance of significant numbers of peripheral blasts & an increase in the percentage of blasts in the bone marrow aspirate/biopsy to > 25% not attributable to any other cause or reappearance or new appearance of extramedullary leukemia. Analysis was performed using Kaplan-Meier estimates. | FAS Population | Posted | Median | 95% Confidence Interval | Days | From date of first response until the date of documented relapse (Maximum treatment duration was 535 days for gilteritinib and 112 days for atezolizumab) |
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| Secondary | Event Free Survival (EFS) | EFS was defined as time from date of first dose until date of documented relapse from CR, CRp or CRi, treatment failure or death from any cause, whichever occurred first. CRc, CR, CRi, CRp were described in Outcome measure #2. For a participant with none of these events, EFS was censored at date of last disease assessment. Relapse after CR, CRp or CRi was defined as reappearance of leukemic blasts in peripheral blood or ≥ 5% blasts in bone marrow aspirate/biopsy not attributable to any other cause or reappearance or new appearance of extramedullary leukemia. Relapse after PR was defined with reappearance of significant numbers of peripheral blasts & an increase in the percentage of blasts in the bone marrow aspirate/biopsy to > 25% not attributable to any other cause or reappearance or new appearance of extramedullary leukemia. Treatment failure was defined as lack of CR, CRp or CRi, & was determined at the end of treatment (EoT). Analysis was performed using Kaplan-Meier estimates. | FAS Population | Posted | Median | 95% Confidence Interval | Days | From the date of first dose until the date of documented relapse from CR, CRp or CRi, treatment failure or death from any cause, whichever occurred first (Maximum treatment duration was 535 days for gilteritinib and 112 days for atezolizumab) |
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| Secondary | Overall Survival (OS) | OS was defined as the time from the date of first dose until the date of death from any cause. For a participant who was not known to have died by the end of study follow-up, overall survival was censored at the date of last contact. Analysis was performed using Kaplan-Meier estimates. | FAS Population | Posted | Median | 95% Confidence Interval | Days | From the date of first dose until the date of death from any cause (Maximum treatment duration was 535 days for gilteritinib and 112 days for atezolizumab) |
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| Secondary | Number of Participants With Treatment-Emergent Adverse Events | An AE was any untoward medical occurrence in a participant administered study drug, & which did not necessarily have to have a causal relationship with this treatment. Abnormalities was defined as AE only if met 1 of the criteria:Induced clinical signs/symptoms, required active intervention, required interruption or discontinuation of ST, abnormality or investigational value was clinically significant. Serious AE:resulted in death, was life threatening, persistent or significant disability/incapacity or substantial disruption of ability to conduct normal life functions, congenital anomaly/birth defect, required hospitalization or prolongation of hospitalization, other medically important events. Any AE recorded on treatment including within 30 days from last study treatment was classified as treatment-emergent AE (TEAE). Grades(Gr) based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) (Gr 1=mild, Gr 2=moderate, Gr 3 =severe, Gr 4 =life threatening, Gr 5 =death). | Safety Population | Posted | Number | Participants | Baseline to 30 days after last study treatment (Maximum treatment duration was 535 days for gilteritinib and 112 days for atezolizumab) |
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| Secondary | Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Score | ECOG performance status was measured on an 6 point scale. 0-Fully active, able to carry on all pre-disease performance without restriction.
| Safety population with available data at specified timepoint | Posted | Number | Participants | Baseline and end of treatment (EoT) (Maximum treatment duration was 535 days for gilteritinib and 112 days for atezolizumab) |
|
Baseline to 30 days after last study treatment (Maximum treatment duration was 535 days for giltertinib and 112 days for atezolizumab)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Gilteritinib 120 mg + Atezolizumab 420 mg | Participants received 120 mg giltertinib (3 tablets of 40 mg) orally, once a day in continuous 28-day cycles in combination with atezolizumab 420 mg adminstered by intravenous infusion (over 60 minutes) once every 2 weeks of 28-day cycle until the participant no longer received clinical benefit from therapy, unacceptable toxicity occurred or the participant met a treatment discontinuation criterion (Maximum treatment duration was 535 days for gilteritinib and 112 days for atezolizumab). | 2 | 3 | 3 | 3 | 3 | 3 |
| EG001 | Gilteritinib 120 mg + Atezolizumab 840 mg | Participants received 120 mg giltertinib (3 tablets of 40 mg) orally, once a day in continuous 28-day cycles in combination with atezolizumab 840 mg adminstered by intravenous infusion (over 60 minutes) once every 2 weeks of 28-day cycle until the participant no longer received clinical benefit from therapy, unacceptable toxicity occurred or the participant met a treatment discontinuation criterion (Maximum treatment duration was 126 days for gilteritinib and 70 days for atezolizumab). | 4 | 8 | 7 | 8 | 8 | 8 |
| 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 |
| |
| Myocarditis | Cardiac disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| Enterocolitis infectious | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| Urinary tract infection pseudomonal | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA v23.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA v23.0 | Systematic Assessment |
| |
| Subdural haematoma | 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 |
| |
| Platelet count decreased | Investigations | MedDRA v23.0 | Systematic Assessment |
| |
| Adult failure to thrive | Metabolism and nutrition disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Laryngeal oedema | Respiratory, thoracic and mediastinal 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 |
| |
| Arrhythmia supraventricular | Cardiac disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Supraventricular extrasystoles | Cardiac disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Ear discomfort | Ear and labyrinth disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Eye haemorrhage | Eye disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Oral disorder | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Paraesthesia oral | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Localised oedema | General disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Nodule | General disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Hepatomegaly | Hepatobiliary disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Ocular icterus | Hepatobiliary disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Bacterial disease carrier | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| Candida infection | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| Clostridium bacteraemia | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| Endocarditis | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| Enterococcal infection | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| Post procedural cellulitis | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| Streptococcal bacteraemia | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| Urinary tract infection enterococcal | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| Contusion | 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 |
| |
| Alanine aminotransferase increased | Investigations | MedDRA v23.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA v23.0 | Systematic Assessment |
| |
| Bacterial test positive | Investigations | MedDRA v23.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA v23.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA v23.0 | Systematic Assessment |
| |
| Blood corticotrophin decreased | Investigations | MedDRA v23.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA v23.0 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA v23.0 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA v23.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA v23.0 | Systematic Assessment |
| |
| Respiratory syncytial virus test positive | Investigations | MedDRA v23.0 | Systematic Assessment |
| |
| Serum ferritin increased | Investigations | MedDRA v23.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA v23.0 | Systematic Assessment |
| |
| Acidosis | 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 |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Hypomagnesaemia | 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 |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Chloroma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | Systematic Assessment |
| |
| Aphasia | Nervous system 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 |
| |
| Lethargy | Nervous system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Device leakage | Product Issues | MedDRA v23.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Oropharyngeal pain | 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 |
| |
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Rales | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Sinus pain | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Hyperhidrosis | 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 |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA v23.0 | Systematic Assessment |
|
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 trial Disclosure | Astellas Pharma Global Development, Inc | 800-888-7704 | astellas.resultsdisclosure@astellas.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 20, 2021 | May 3, 2022 | SAP_001.pdf |
Not provided
| 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 |
| C000594389 | atezolizumab |
Not provided
Not provided
Not provided
| 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 |
|
| OG001 | Gilteritinib 120 mg + Atezolizumab 840 mg | Participants received 120 mg giltertinib (3 tablets of 40 mg) orally, once a day in continuous 28-day cycles in combination with atezolizumab 840 mg adminstered by intravenous infusion (over 60 minutes) once every 2 weeks of 28-day cycle until the participant no longer received clinical benefit from therapy, unacceptable toxicity occurred or the participant met a treatment discontinuation criterion (Maximum treatment duration was 126 days for gilteritinib and 70 days for atezolizumab). |
|
|
|
|
Participants received 120 mg giltertinib (3 tablets of 40 mg) orally, once a day in continuous 28-day cycles in combination with atezolizumab 840 mg adminstered by intravenous infusion (over 60 minutes) once every 2 weeks of 28-day cycle until the participant no longer received clinical benefit from therapy, unacceptable toxicity occurred or the participant met a treatment discontinuation criterion (Maximum treatment duration was 126 days for gilteritinib and 70 days for atezolizumab). |
|
|
| OG001 | Gilteritinib 120 mg + Atezolizumab 840 mg | Participants received 120 mg giltertinib (3 tablets of 40 mg) orally, once a day in continuous 28-day cycles in combination with atezolizumab 840 mg adminstered by intravenous infusion (over 60 minutes) once every 2 weeks of 28-day cycle until the participant no longer received clinical benefit from therapy, unacceptable toxicity occurred or the participant met a treatment discontinuation criterion (Maximum treatment duration was 126 days for gilteritinib and 70 days for atezolizumab). |
|
|
| OG001 | Gilteritinib 120 mg + Atezolizumab 840 mg | Participants received 120 mg giltertinib (3 tablets of 40 mg) orally, once a day in continuous 28-day cycles in combination with atezolizumab 840 mg adminstered by intravenous infusion (over 60 minutes) once every 2 weeks of 28-day cycle until the participant no longer received clinical benefit from therapy, unacceptable toxicity occurred or the participant met a treatment discontinuation criterion (Maximum treatment duration was 126 days for gilteritinib and 70 days for atezolizumab). |
|
|
| OG001 | Gilteritinib 120 mg + Atezolizumab 840 mg | Participants received 120 mg giltertinib (3 tablets of 40 mg) orally, once a day in continuous 28-day cycles in combination with atezolizumab 840 mg adminstered by intravenous infusion (over 60 minutes) once every 2 weeks of 28-day cycle until the participant no longer received clinical benefit from therapy, unacceptable toxicity occurred or the participant met a treatment discontinuation criterion (Maximum treatment duration was 126 days for gilteritinib and 70 days for atezolizumab). |
|
|
| OG001 | Gilteritinib 120 mg + Atezolizumab 840 mg | Participants received 120 mg giltertinib (3 tablets of 40 mg) orally, once a day in continuous 28-day cycles in combination with atezolizumab 840 mg adminstered by intravenous infusion (over 60 minutes) once every 2 weeks of 28-day cycle until the participant no longer received clinical benefit from therapy, unacceptable toxicity occurred or the participant met a treatment discontinuation criterion (Maximum treatment duration was 126 days for gilteritinib and 70 days for atezolizumab). |
|
|
|
|
| OG001 | Gilteritinib 120 mg + Atezolizumab 840 mg | Participants received 120 mg giltertinib (3 tablets of 40 mg) orally, once a day in continuous 28-day cycles in combination with atezolizumab 840 mg adminstered by intravenous infusion (over 60 minutes) once every 2 weeks of 28-day cycle until the participant no longer received clinical benefit from therapy, unacceptable toxicity occurred or the participant met a treatment discontinuation criterion (Maximum treatment duration was 126 days for gilteritinib and 70 days for atezolizumab). |
|
|
Participants received 120 mg giltertinib (3 tablets of 40 mg) orally, once a day in continuous 28-day cycles in combination with atezolizumab 840 mg adminstered by intravenous infusion (over 60 minutes) once every 2 weeks of 28-day cycle until the participant no longer received clinical benefit from therapy, unacceptable toxicity occurred or the participant met a treatment discontinuation criterion (Maximum treatment duration was 126 days for gilteritinib and 70 days for atezolizumab). |
|
|