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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-001279-15 | EudraCT Number |
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Sponsor decision
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The primary objective of this study is to evaluate the safety of lanraplenib (LANRA) in combination with the FMS-like tyrosine kinase 3 (FLT3) inhibitor gilteritinib, in participants with relapsed or refractory (R/R) FLT3-mutated acute myeloid leukemia (AML).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LANRA 20 mg QD + Gilteritinib 120 mg QD | Experimental | Participants received LANRA 20 mg once daily (QD) as oral tablets in consecutive 28-day cycles starting from Cycle 1 Day 1. Participants also received gilteritinib 120 mg QD as oral tablets in consecutive 28-day cycles starting from Cycle 1 Day 2. Participants received treatment until progression/relapse or lack of at least a partial remission (PR) after 6 months of study treatment, intolerance, or withdrawal from treatment by the participant or study investigator. |
|
| LANRA 40 mg QD + Gilteritinib 120 mg QD | Experimental | Participants received LANRA 40 mg QD as oral tablets in consecutive 28-day cycles starting from Cycle 1 Day 1. Participants also received gilteritinib 120 mg QD as oral tablets in consecutive 28-day cycles starting from Cycle 1 Day 2. Participants received treatment until progression/relapse or lack of at least a PR after 6 months of study treatment, intolerance, or withdrawal from treatment by the participant or study investigator. |
|
| LANRA 60 mg QD + Gilteritinib 120 mg QD | Experimental | Participants received LANRA 60 mg QD as oral tablets in consecutive 28-day cycles starting from Cycle 1 Day 1. Participants also received gilteritinib 120 mg QD as oral tablets in consecutive 28-day cycles starting from Cycle 1 Day 2. Participants received treatment until progression/relapse or lack of at least a PR after 6 months of study treatment, intolerance, or withdrawal from treatment by the participant or study investigator. |
|
| LANRA 90 mg QD + Gilteritinib 120 mg QD |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lanraplenib | Drug | Orally via tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) | A TEAE was any unfavorable or unintended sign, symptom, laboratory abnormality or disease (new or exacerbated) temporally associated with the use of a study drug, whether considered causally related to the study drug or not that started after the first dose of the earliest study drug through the lesser of non-protocol anti-leukemic therapy initiation or end of treatment visit. A serious TEAE was defined as any TEAE that:
TEAEs were graded for severity based on the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 as follows:
| Cycle 1 Day 1 (each cycle was 28 days) to 30 days after last dose of either LANRA or gilteritinib or initiation of non-protocol antileukemic therapy, whichever was earlier (maximum duration of treatment was 183 days) |
| Number of Participants Who Experienced a Dose-limiting Toxicity (DLT) for LANRA | A DLT was defined as any of the following occurring within the DLT assessment period:
DLTs were graded for severity based on the NCI-CTCAE version 5.0 as follows:
| Cycle 1 Day 1 to pre-dose Cycle 2 Day 1 (each cycle was 28 days) |
| Maximally Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) of LANRA in Combination With Standard Doses of Gilteritinib | The MTD/RP2D was defined as the highest dose with either 0 of 3 or no more than 1 of 6 patients with LANRA-related DLTs. All decisions regarding dose escalation including declaration of the MTD/RP2D were made by the dose-escalation committee (DEC). |
| Measure | Description | Time Frame |
|---|---|---|
| Maximal Plasma Concentration (Cmax) of LANRA | Cmax was derived from plasma concentrations of LANRA using standard non-compartmental methods and actual sample times. | Cycle 1 Day 1 and Cycle 1 Day 15: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8 and 24 hours post-dose. |
| Time to Cmax (Tmax) of LANRA |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Los Angeles (UCLA) | Los Angeles | California | 990095 | United States | ||
| The Blood and Marrow Transplant Group of Georgia |
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A total of 35 participants were screened, of whom 24 participants were enrolled and received study treatment.
A total of 24 participants were enrolled at sites in the United States and Spain.
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| ID | Title | Description |
|---|---|---|
| FG000 | LANRA 20 mg QD + Gilteritinib 120 mg QD | Participants received LANRA 20 mg once daily (QD) as oral tablets in consecutive 28-day cycles starting from Cycle 1 Day 1. Participants also received gilteritinib 120 mg QD as oral tablets in consecutive 28-day cycles starting from Cycle 1 Day 2. Participants received treatment until progression/relapse or lack of at least a partial remission (PR) after 6 months of study treatment, intolerance, or withdrawal from treatment by the participant or study investigator. |
| 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 | May 30, 2023 | Jul 11, 2024 |
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| Experimental |
Participants received LANRA 90 mg QD as oral tablets in consecutive 28-day cycles starting from Cycle 1 Day 1. Participants also received gilteritinib 120 mg QD as oral tablets in consecutive 28-day cycles starting from Cycle 1 Day 2. Participants received treatment until progression/relapse or lack of at least a PR after 6 months of study treatment, intolerance, or withdrawal from treatment by the participant or study investigator. |
|
|
| Gilteritinib | Drug | Orally via tablets |
|
|
| Cycle 1 Day 1 to pre-dose Cycle 2 Day 1 (each cycle was 28 days) |
Tmax was derived from plasma concentrations of LANRA using standard non-compartmental methods and actual sample times. |
| Cycle 1 Day 1 and Cycle 1 Day 15: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8 and 24 hours post-dose. |
| Area of the Plasma Concentration x Time Curve From Hour 0 to the Last Measurable Time Point (AUC0-last) of LANRA | AUC0-last was derived from plasma concentrations of LANRA using standard non-compartmental methods and actual sample times. | Cycle 1 Day 1 and Cycle 1 Day 15: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8 and 24 hours post-dose. |
| Cmax of Gilteritinib | Cmax was derived from plasma concentrations of gilteritinib using standard non-compartmental methods and actual sample times. | Cycle 1 Day 15: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8 and 24 hours post-dose. |
| Tmax of Gilteritinib | Tmax was derived from plasma concentrations of gilteritinib using standard non-compartmental methods and actual sample times. | Cycle 1 Day 15: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8 and 24 hours post-dose. |
| AUC0-last of Gilteritinib | AUC0-last was derived from plasma concentrations of gilteritinib using standard non-compartmental methods and actual sample times. | Cycle 1 Day 15: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8 and 24 hours post-dose. |
| Composite Complete Remission (cCR) Rate Per European LeukemiaNet (ELN) 2017 Criteria | Percentage of participants with cCR included CR and CR with partial hematologic recovery (CRh). CR required all of the following, per ELN 2017 criteria:
CRh required all aforementioned CR criteria except for the below:
| Cycle 1 Day 1 until occurrence of documented CR or CRh (maximum duration of follow-up was 16.1 months). |
| Duration of Response (DOR) | DOR was defined as the time from first qualifying response (CR/CRh) until relapse or death from any cause, as assessed by study investigators. CR required all of the following:
CRh required all aforementioned CR criteria except for the below:
Relapse was defined as the reappearance of circulating blasts or ≥ 5% blasts in the bone marrow not attributable to any other cause or reappearance of cytologically or biopsy documented extramedullary disease. | From first qualifying response (CR/CRh) until relapse or death from any cause (maximum duration of follow-up was 16.1 months). |
| Event-free Survival (EFS) | EFS was defined as the time from treatment onset until treatment failure (ie, failure to achieve CR/CRh, relapse from CR/CRh, or death from any cause). CR required all of the following:
CRh required all aforementioned CR criteria except for the below:
Relapse was defined as the reappearance of circulating blasts or ≥ 5% blasts in the bone marrow not attributable to any other cause or reappearance of cytologically or biopsy documented extramedullary disease. | Cycle 1 Day 1 to treatment failure (ie, failure to achieve CR or CRh, relapse from CR/CRh or death from any cause) (maximum duration of follow-up was 16.1 months). |
| Overall Survival | Overall survival was defined as the time from enrollment until death from any cause. Overall survival was estimated using Kaplan-Meier methodology. | Enrollment until death from any cause (maximum duration of follow-up was 16.1 months). |
| Atlanta |
| Georgia |
| 30342 |
| United States |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| Texas Oncology - Baylor Charles A. Sammons Cancer Center | Dallas | Texas | 75246 | United States |
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Froedtert Hospital | Milwaukee | Wisconsin | 53226 | United States |
| Hospital Universitario 12 de Octubre | Madrid | Avenida de Córdoba Sin Número | 28041 | Spain |
| Hospital Germans Trias i Pujol | Barcelona | Badalona | 08916 | Spain |
| MD Anderson Cancer Center Madrid | Madrid | Calle de Arturo Soria | 270 | Spain |
| Hospital Universitari Vall d'Hebrón | Barcelona | 08035 | Spain |
| Institut Català d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet) | Barcelona | 08908 | Spain |
| Hospital Clínic de Barcelona | Barcelona | 170 | Spain |
| Hospital San Pedro de Alcantara | Cáceres | 10001 | Spain |
| Hospital Universitario Fundación Jiménez Díaz | Madrid | 28040 | Spain |
| Hospital Universitari i Politècnic La Fe | Valencia | 46026 | Spain |
| FG001 | LANRA 40 mg QD + Gilteritinib 120 mg QD | Participants received LANRA 40 mg QD as oral tablets in consecutive 28-day cycles starting from Cycle 1 Day 1. Participants also received gilteritinib 120 mg QD as oral tablets in consecutive 28-day cycles starting from Cycle 1 Day 2. Participants received treatment until progression/relapse or lack of at least a PR after 6 months of study treatment, intolerance, or withdrawal from treatment by the participant or study investigator. |
| FG002 | LANRA 60 mg QD + Gilteritinib 120 mg QD | Participants received LANRA 60 mg QD as oral tablets in consecutive 28-day cycles starting from Cycle 1 Day 1. Participants also received gilteritinib 120 mg QD as oral tablets in consecutive 28-day cycles starting from Cycle 1 Day 2. Participants received treatment until progression/relapse or lack of at least a PR after 6 months of study treatment, intolerance, or withdrawal from treatment by the participant or study investigator. |
| FG003 | LANRA 90 mg QD + Gilteritinib 120 mg QD | Participants received LANRA 90 mg QD as oral tablets in consecutive 28-day cycles starting from Cycle 1 Day 1. Participants also received gilteritinib 120 mg QD as oral tablets in consecutive 28-day cycles starting from Cycle 1 Day 2. Participants received treatment until progression/relapse or lack of at least a PR after 6 months of study treatment, intolerance, or withdrawal from treatment by the participant or study investigator. |
| COMPLETED |
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| NOT COMPLETED |
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Safety Population: Consisted of all participants who received ≥ 1 dose of either study drug and had at least 1 on-treatment safety-related observation.
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| ID | Title | Description |
|---|---|---|
| BG000 | LANRA 20 mg QD + Gilteritinib 120 mg QD | Participants received LANRA 20 mg QD as oral tablets in consecutive 28-day cycles starting from Cycle 1 Day 1. Participants also received gilteritinib 120 mg QD as oral tablets in consecutive 28-day cycles starting from Cycle 1 Day 2. Participants received treatment until progression/relapse or lack of at least a PR after 6 months of study treatment, intolerance, or withdrawal from treatment by the participant or study investigator. |
| BG001 | LANRA 40 mg QD + Gilteritinib 120 mg QD | Participants received LANRA 40 mg QD as oral tablets in consecutive 28-day cycles starting from Cycle 1 Day 1. Participants also received gilteritinib 120 mg QD as oral tablets in consecutive 28-day cycles starting from Cycle 1 Day 2. Participants received treatment until progression/relapse or lack of at least a PR after 6 months of study treatment, intolerance, or withdrawal from treatment by the participant or study investigator. |
| BG002 | LANRA 60 mg QD + Gilteritinib 120 mg QD | Participants received LANRA 60 mg QD as oral tablets in consecutive 28-day cycles starting from Cycle 1 Day 1. Participants also received gilteritinib 120 mg QD as oral tablets in consecutive 28-day cycles starting from Cycle 1 Day 2. Participants received treatment until progression/relapse or lack of at least a PR after 6 months of study treatment, intolerance, or withdrawal from treatment by the participant or study investigator. |
| BG003 | LANRA 90 mg QD + Gilteritinib 120 mg QD | Participants received LANRA 90 mg QD as oral tablets in consecutive 28-day cycles starting from Cycle 1 Day 1. Participants also received gilteritinib 120 mg QD as oral tablets in consecutive 28-day cycles starting from Cycle 1 Day 2. Participants received treatment until progression/relapse or lack of at least a PR after 6 months of study treatment, intolerance, or withdrawal from treatment by the participant or study investigator. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| 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/Ethnicity, Customized | Count of Participants | Participants |
|
| 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 | Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) | A TEAE was any unfavorable or unintended sign, symptom, laboratory abnormality or disease (new or exacerbated) temporally associated with the use of a study drug, whether considered causally related to the study drug or not that started after the first dose of the earliest study drug through the lesser of non-protocol anti-leukemic therapy initiation or end of treatment visit. A serious TEAE was defined as any TEAE that:
TEAEs were graded for severity based on the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 as follows:
| Safety Population: Consisted of all participants who received ≥ 1 dose of either study drug and had at least 1 on-treatment safety-related observation. | Posted | Count of Participants | Participants | Cycle 1 Day 1 (each cycle was 28 days) to 30 days after last dose of either LANRA or gilteritinib or initiation of non-protocol antileukemic therapy, whichever was earlier (maximum duration of treatment was 183 days) |
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| Primary | Number of Participants Who Experienced a Dose-limiting Toxicity (DLT) for LANRA | A DLT was defined as any of the following occurring within the DLT assessment period:
DLTs were graded for severity based on the NCI-CTCAE version 5.0 as follows:
| Safety Population: Consisted of all participants who received ≥ 1 dose of either study drug and had at least 1 on-treatment safety-related observation. | Posted | Count of Participants | Participants | Cycle 1 Day 1 to pre-dose Cycle 2 Day 1 (each cycle was 28 days) |
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| Primary | Maximally Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) of LANRA in Combination With Standard Doses of Gilteritinib | The MTD/RP2D was defined as the highest dose with either 0 of 3 or no more than 1 of 6 patients with LANRA-related DLTs. All decisions regarding dose escalation including declaration of the MTD/RP2D were made by the dose-escalation committee (DEC). | The study was terminated before MTD/RP2D could be determined. | Posted | Cycle 1 Day 1 to pre-dose Cycle 2 Day 1 (each cycle was 28 days) |
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| Secondary | Maximal Plasma Concentration (Cmax) of LANRA | Cmax was derived from plasma concentrations of LANRA using standard non-compartmental methods and actual sample times. | Pharmacokinetic (PK) Population: Consisted of all participants with at least 1 post-dose LANRA plasma concentration with available data at each PK assessment time point. | Posted | Mean | Standard Deviation | ng/mL | Cycle 1 Day 1 and Cycle 1 Day 15: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8 and 24 hours post-dose. |
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| Secondary | Time to Cmax (Tmax) of LANRA | Tmax was derived from plasma concentrations of LANRA using standard non-compartmental methods and actual sample times. | PK Population: Consisted of all participants with at least 1 post-dose LANRA plasma concentration with available data at each PK assessment time point. | Posted | Mean | Standard Deviation | hours | Cycle 1 Day 1 and Cycle 1 Day 15: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8 and 24 hours post-dose. |
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| Secondary | Area of the Plasma Concentration x Time Curve From Hour 0 to the Last Measurable Time Point (AUC0-last) of LANRA | AUC0-last was derived from plasma concentrations of LANRA using standard non-compartmental methods and actual sample times. | PK Population: Consisted of all participants with at least 1 post-dose LANRA plasma concentration with available data at each PK assessment time point. | Posted | Mean | Standard Deviation | h*ng/mL | Cycle 1 Day 1 and Cycle 1 Day 15: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8 and 24 hours post-dose. |
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| Secondary | Cmax of Gilteritinib | Cmax was derived from plasma concentrations of gilteritinib using standard non-compartmental methods and actual sample times. | PK Population: Consisted of all participants with at least 1 post-dose gilteritinib plasma concentration with available data at each PK assessment time point. | Posted | Mean | Standard Deviation | ng/mL | Cycle 1 Day 15: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8 and 24 hours post-dose. |
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| Secondary | Tmax of Gilteritinib | Tmax was derived from plasma concentrations of gilteritinib using standard non-compartmental methods and actual sample times. | PK Population: Consisted of all participants with at least 1 post-dose gilteritinib plasma concentration with available data at each PK assessment time point. | Posted | Mean | Standard Deviation | hours | Cycle 1 Day 15: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8 and 24 hours post-dose. |
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| Secondary | AUC0-last of Gilteritinib | AUC0-last was derived from plasma concentrations of gilteritinib using standard non-compartmental methods and actual sample times. | PK Population: Consisted of all participants with at least 1 post-dose gilteritinib plasma concentration with available data at each PK assessment time point. | Posted | Mean | Standard Deviation | h*ng/mL | Cycle 1 Day 15: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8 and 24 hours post-dose. |
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| Secondary | Composite Complete Remission (cCR) Rate Per European LeukemiaNet (ELN) 2017 Criteria | Percentage of participants with cCR included CR and CR with partial hematologic recovery (CRh). CR required all of the following, per ELN 2017 criteria:
CRh required all aforementioned CR criteria except for the below:
| Efficacy Evaluable Population: Consisted of all participants who received ≥1 dose of either study drug and completed the first protocol-specified response assessment or discontinued study treatment for toxicity or died prior to the first response assessment. Participants with no post-baseline response assessments were considered non-responders. | Posted | Number | 95% Confidence Interval | percentage of participants | Cycle 1 Day 1 until occurrence of documented CR or CRh (maximum duration of follow-up was 16.1 months). |
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| Secondary | Duration of Response (DOR) | DOR was defined as the time from first qualifying response (CR/CRh) until relapse or death from any cause, as assessed by study investigators. CR required all of the following:
CRh required all aforementioned CR criteria except for the below:
Relapse was defined as the reappearance of circulating blasts or ≥ 5% blasts in the bone marrow not attributable to any other cause or reappearance of cytologically or biopsy documented extramedullary disease. | Efficacy Evaluable Population: Consisted of only participants who had a CR/CRh. | Posted | From first qualifying response (CR/CRh) until relapse or death from any cause (maximum duration of follow-up was 16.1 months). |
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| Secondary | Event-free Survival (EFS) | EFS was defined as the time from treatment onset until treatment failure (ie, failure to achieve CR/CRh, relapse from CR/CRh, or death from any cause). CR required all of the following:
CRh required all aforementioned CR criteria except for the below:
Relapse was defined as the reappearance of circulating blasts or ≥ 5% blasts in the bone marrow not attributable to any other cause or reappearance of cytologically or biopsy documented extramedullary disease. | Event free survival could not be estimated as no participants had a CR/CRh. | Posted | Cycle 1 Day 1 to treatment failure (ie, failure to achieve CR or CRh, relapse from CR/CRh or death from any cause) (maximum duration of follow-up was 16.1 months). |
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| Secondary | Overall Survival | Overall survival was defined as the time from enrollment until death from any cause. Overall survival was estimated using Kaplan-Meier methodology. | Safety Population: Consisted of all participants who received ≥ 1 dose of either study drug and had at least 1 on-treatment safety-related observation. Participants alive at last follow-up were censored at the date of last contact. | Posted | Median | 95% Confidence Interval | months | Enrollment until death from any cause (maximum duration of follow-up was 16.1 months). |
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Serious AEs and Other AEs: Cycle 1 Day 1 (each cycle was 28 days) to 30 days after last dose of either LANRA or gilteritinib or initiation of non-protocol antileukemic therapy, whichever was earlier (maximum duration of treatment was 183 days). All-cause mortality: Enrollment to end of study (maximum duration of follow-up was 16.1 months).
Safety Population: Consisted of all participants who received ≥ 1 dose of either study drug and had at least 1 on-treatment safety-related observation.
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 | LANRA 20 mg QD + Gilteritinib 120 mg QD | Participants received LANRA 20 mg QD as oral tablets in consecutive 28-day cycles starting from Cycle 1 Day 1. Participants also received gilteritinib 120 mg QD as oral tablets in consecutive 28-day cycles starting from Cycle 1 Day 2. Participants received treatment until progression/relapse or lack of at least a PR after 6 months of study treatment, intolerance, or withdrawal from treatment by the participant or study investigator. | 9 | 14 | 11 | 14 | 14 | 14 |
| EG001 | LANRA 40 mg QD + Gilteritinib 120 mg QD | Participants received LANRA 40 mg QD as oral tablets in consecutive 28-day cycles starting from Cycle 1 Day 1. Participants also received gilteritinib 120 mg QD as oral tablets in consecutive 28-day cycles starting from Cycle 1 Day 2. Participants received treatment until progression/relapse or lack of at least a PR after 6 months of study treatment, intolerance, or withdrawal from treatment by the participant or study investigator. | 3 | 3 | 3 | 3 | 3 | 3 |
| EG002 | LANRA 60 mg QD + Gilteritinib 120 mg QD | Participants received LANRA 60 mg QD as oral tablets in consecutive 28-day cycles starting from Cycle 1 Day 1. Participants also received gilteritinib 120 mg QD as oral tablets in consecutive 28-day cycles starting from Cycle 1 Day 2. Participants received treatment until progression/relapse or lack of at least a PR after 6 months of study treatment, intolerance, or withdrawal from treatment by the participant or study investigator. | 2 | 3 | 3 | 3 | 3 | 3 |
| EG003 | LANRA 90 mg QD + Gilteritinib 120 mg QD | Participants received LANRA 90 mg QD as oral tablets in consecutive 28-day cycles starting from Cycle 1 Day 1. Participants also received gilteritinib 120 mg QD as oral tablets in consecutive 28-day cycles starting from Cycle 1 Day 2. Participants received treatment until progression/relapse or lack of at least a PR after 6 months of study treatment, intolerance, or withdrawal from treatment by the participant or study investigator. | 4 | 4 | 4 | 4 | 3 | 4 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Pneumonia fungal | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Streptococcal bacteraemia | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Enterococcal bacteraemia | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Enterococcal infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Enterocolitis infectious | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Escherichia infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Klebsiella bacteraemia | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Pneumonia staphylococcal | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hyperleukocytosis | Blood and lymphatic system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Intracranial mass | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Neutropenic colitis | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Craniofacial fracture | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Subdural haemorrhage | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Acute febrile neutrophilic dermatosis | Skin and subcutaneous tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Superficial vein thrombosis | Vascular disorders | MedDRA (25.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chills | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Catheter site pain | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Facial pain | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Generalised oedema | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Localised oedema | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Bilirubin conjugated increased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Clostridium test positive | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Pantoea agglomerans test positive | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Troponin I increased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Enterococcal bacteraemia | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Catheter site infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Enterobacter infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Enterococcal infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Enterovirus infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Perichondritis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Pneumonia klebsiella | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Rhinovirus infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Splenic infarction | Blood and lymphatic system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hypoaesthesia oral | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Brain injury | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pulmonary alveolar haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Acute febrile neutrophilic dermatosis | Skin and subcutaneous tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Blister | Skin and subcutaneous tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Skin mass | Skin and subcutaneous tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Umbilical haematoma | Skin and subcutaneous tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Face injury | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Transfusion reaction | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Dysphoria | Psychiatric disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Renal haemorrhage | Renal and urinary disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Cholestasis | Hepatobiliary disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Acute graft versus host disease | Immune system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Differentiation syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (25.1) | Systematic Assessment |
|
In light of the Sponsor's decision to terminate the trial at completion of Phase 1b, all analyses were restricted to results from Phase 1b participants only. Phase 2 was not enrolled.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| VP, Corporate Affairs | Kronos Bio, Inc. | +16507815200 | media@kronosbio.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 15, 2024 | Jul 11, 2024 | SAP_001.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 |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Not Reported |
|
| Other |
|
| TESAEs |
|
| Grade 3 or Grade 4 TEAEs |
|
| AEs Leading to Death (Grade 5) |
|
| TEAEs Related to LANRA |
|
| TEAEs Related to Gilteritinib |
|
| TEAEs Leading to Dose Reduction of LANRA |
|
| TEAEs Leading to Dose Reduction of Gilteritinib |
|
| TEAEs Leading to LANRA Interruption |
|
| TEAEs Leading to Gilteritinib Interruption |
|
| TEAEs Leading to Treatment Discontinuation of LANRA |
|
| TEAEs Leading to Treatment Discontinuation of Gilteritinib |
|
| LANRA 40 mg QD + Gilteritinib 120 mg QD |
Participants received LANRA 40 mg QD as oral tablets in consecutive 28-day cycles starting from Cycle 1 Day 1. Participants also received gilteritinib 120 mg QD as oral tablets in consecutive 28-day cycles starting from Cycle 1 Day 2. Participants received treatment until progression/relapse or lack of at least a PR after 6 months of study treatment, intolerance, or withdrawal from treatment by the participant or study investigator. |
| OG002 | LANRA 60 mg QD + Gilteritinib 120 mg QD | Participants received LANRA 60 mg QD as oral tablets in consecutive 28-day cycles starting from Cycle 1 Day 1. Participants also received gilteritinib 120 mg QD as oral tablets in consecutive 28-day cycles starting from Cycle 1 Day 2. Participants received treatment until progression/relapse or lack of at least a PR after 6 months of study treatment, intolerance, or withdrawal from treatment by the participant or study investigator. |
| OG003 | LANRA 90 mg QD + Gilteritinib 120 mg QD | Participants received LANRA 90 mg QD as oral tablets in consecutive 28-day cycles starting from Cycle 1 Day 1. Participants also received gilteritinib 120 mg QD as oral tablets in consecutive 28-day cycles starting from Cycle 1 Day 2. Participants received treatment until progression/relapse or lack of at least a PR after 6 months of study treatment, intolerance, or withdrawal from treatment by the participant or study investigator. |
|
|
| OG002 | LANRA 60 mg QD + Gilteritinib 120 mg QD | Participants received LANRA 60 mg QD as oral tablets in consecutive 28-day cycles starting from Cycle 1 Day 1. Participants also received gilteritinib 120 mg QD as oral tablets in consecutive 28-day cycles starting from Cycle 1 Day 2. Participants received treatment until progression/relapse or lack of at least a PR after 6 months of study treatment, intolerance, or withdrawal from treatment by the participant or study investigator. |
| OG003 | LANRA 90 mg QD + Gilteritinib 120 mg QD | Participants received LANRA 90 mg QD as oral tablets in consecutive 28-day cycles starting from Cycle 1 Day 1. Participants also received gilteritinib 120 mg QD as oral tablets in consecutive 28-day cycles starting from Cycle 1 Day 2. Participants received treatment until progression/relapse or lack of at least a PR after 6 months of study treatment, intolerance, or withdrawal from treatment by the participant or study investigator. |
|
|
| OG002 | LANRA 60 mg QD + Gilteritinib 120 mg QD | Participants received LANRA 60 mg QD as oral tablets in consecutive 28-day cycles starting from Cycle 1 Day 1. Participants also received gilteritinib 120 mg QD as oral tablets in consecutive 28-day cycles starting from Cycle 1 Day 2. Participants received treatment until progression/relapse or lack of at least a PR after 6 months of study treatment, intolerance, or withdrawal from treatment by the participant or study investigator. |
| OG003 | LANRA 90 mg QD + Gilteritinib 120 mg QD | Participants received LANRA 90 mg QD as oral tablets in consecutive 28-day cycles starting from Cycle 1 Day 1. Participants also received gilteritinib 120 mg QD as oral tablets in consecutive 28-day cycles starting from Cycle 1 Day 2. Participants received treatment until progression/relapse or lack of at least a PR after 6 months of study treatment, intolerance, or withdrawal from treatment by the participant or study investigator. |
|
|
| OG002 | LANRA 60 mg QD + Gilteritinib 120 mg QD | Participants received LANRA 60 mg QD as oral tablets in consecutive 28-day cycles starting from Cycle 1 Day 1. Participants also received gilteritinib 120 mg QD as oral tablets in consecutive 28-day cycles starting from Cycle 1 Day 2. Participants received treatment until progression/relapse or lack of at least a PR after 6 months of study treatment, intolerance, or withdrawal from treatment by the participant or study investigator. |
| OG003 | LANRA 90 mg QD + Gilteritinib 120 mg QD | Participants received LANRA 90 mg QD as oral tablets in consecutive 28-day cycles starting from Cycle 1 Day 1. Participants also received gilteritinib 120 mg QD as oral tablets in consecutive 28-day cycles starting from Cycle 1 Day 2. Participants received treatment until progression/relapse or lack of at least a PR after 6 months of study treatment, intolerance, or withdrawal from treatment by the participant or study investigator. |
|
|
| OG002 | LANRA 60 mg QD + Gilteritinib 120 mg QD | Participants received LANRA 60 mg QD as oral tablets in consecutive 28-day cycles starting from Cycle 1 Day 1. Participants also received gilteritinib 120 mg QD as oral tablets in consecutive 28-day cycles starting from Cycle 1 Day 2. Participants received treatment until progression/relapse or lack of at least a PR after 6 months of study treatment, intolerance, or withdrawal from treatment by the participant or study investigator. |
| OG003 | LANRA 90 mg QD + Gilteritinib 120 mg QD | Participants received LANRA 90 mg QD as oral tablets in consecutive 28-day cycles starting from Cycle 1 Day 1. Participants also received gilteritinib 120 mg QD as oral tablets in consecutive 28-day cycles starting from Cycle 1 Day 2. Participants received treatment until progression/relapse or lack of at least a PR after 6 months of study treatment, intolerance, or withdrawal from treatment by the participant or study investigator. |
|
|
| OG002 | LANRA 60 mg QD + Gilteritinib 120 mg QD | Participants received LANRA 60 mg QD as oral tablets in consecutive 28-day cycles starting from Cycle 1 Day 1. Participants also received gilteritinib 120 mg QD as oral tablets in consecutive 28-day cycles starting from Cycle 1 Day 2. Participants received treatment until progression/relapse or lack of at least a PR after 6 months of study treatment, intolerance, or withdrawal from treatment by the participant or study investigator. |
| OG003 | LANRA 90 mg QD + Gilteritinib 120 mg QD | Participants received LANRA 90 mg QD as oral tablets in consecutive 28-day cycles starting from Cycle 1 Day 1. Participants also received gilteritinib 120 mg QD as oral tablets in consecutive 28-day cycles starting from Cycle 1 Day 2. Participants received treatment until progression/relapse or lack of at least a PR after 6 months of study treatment, intolerance, or withdrawal from treatment by the participant or study investigator. |
|
|
| OG002 | LANRA 60 mg QD + Gilteritinib 120 mg QD | Participants received LANRA 60 mg QD as oral tablets in consecutive 28-day cycles starting from Cycle 1 Day 1. Participants also received gilteritinib 120 mg QD as oral tablets in consecutive 28-day cycles starting from Cycle 1 Day 2. Participants received treatment until progression/relapse or lack of at least a PR after 6 months of study treatment, intolerance, or withdrawal from treatment by the participant or study investigator. |
| OG003 | LANRA 90 mg QD + Gilteritinib 120 mg QD | Participants received LANRA 90 mg QD as oral tablets in consecutive 28-day cycles starting from Cycle 1 Day 1. Participants also received gilteritinib 120 mg QD as oral tablets in consecutive 28-day cycles starting from Cycle 1 Day 2. Participants received treatment until progression/relapse or lack of at least a PR after 6 months of study treatment, intolerance, or withdrawal from treatment by the participant or study investigator. |
|
|
| OG001 | LANRA 40 mg QD + Gilteritinib 120 mg QD | Participants received LANRA 40 mg QD as oral tablets in consecutive 28-day cycles starting from Cycle 1 Day 1. Participants also received gilteritinib 120 mg QD as oral tablets in consecutive 28-day cycles starting from Cycle 1 Day 2. Participants received treatment until progression/relapse or lack of at least a PR after 6 months of study treatment, intolerance, or withdrawal from treatment by the participant or study investigator. |
| OG002 | LANRA 60 mg QD + Gilteritinib 120 mg QD | Participants received LANRA 60 mg QD as oral tablets in consecutive 28-day cycles starting from Cycle 1 Day 1. Participants also received gilteritinib 120 mg QD as oral tablets in consecutive 28-day cycles starting from Cycle 1 Day 2. Participants received treatment until progression/relapse or lack of at least a PR after 6 months of study treatment, intolerance, or withdrawal from treatment by the participant or study investigator. |
| OG003 | LANRA 90 mg QD + Gilteritinib 120 mg QD | Participants received LANRA 90 mg QD as oral tablets in consecutive 28-day cycles starting from Cycle 1 Day 1. Participants also received gilteritinib 120 mg QD as oral tablets in consecutive 28-day cycles starting from Cycle 1 Day 2. Participants received treatment until progression/relapse or lack of at least a PR after 6 months of study treatment, intolerance, or withdrawal from treatment by the participant or study investigator. |
|
|
| LANRA 40 mg QD + Gilteritinib 120 mg QD |
Participants received LANRA 40 mg QD as oral tablets in consecutive 28-day cycles starting from Cycle 1 Day 1. Participants also received gilteritinib 120 mg QD as oral tablets in consecutive 28-day cycles starting from Cycle 1 Day 2. Participants received treatment until progression/relapse or lack of at least a PR after 6 months of study treatment, intolerance, or withdrawal from treatment by the participant or study investigator. |
| OG002 | LANRA 60 mg QD + Gilteritinib 120 mg QD | Participants received LANRA 60 mg QD as oral tablets in consecutive 28-day cycles starting from Cycle 1 Day 1. Participants also received gilteritinib 120 mg QD as oral tablets in consecutive 28-day cycles starting from Cycle 1 Day 2. Participants received treatment until progression/relapse or lack of at least a PR after 6 months of study treatment, intolerance, or withdrawal from treatment by the participant or study investigator. |
| OG003 | LANRA 90 mg QD + Gilteritinib 120 mg QD | Participants received LANRA 90 mg QD as oral tablets in consecutive 28-day cycles starting from Cycle 1 Day 1. Participants also received gilteritinib 120 mg QD as oral tablets in consecutive 28-day cycles starting from Cycle 1 Day 2. Participants received treatment until progression/relapse or lack of at least a PR after 6 months of study treatment, intolerance, or withdrawal from treatment by the participant or study investigator. |
|
| OG001 |
| LANRA 40 mg QD + Gilteritinib 120 mg QD |
Participants received LANRA 40 mg QD as oral tablets in consecutive 28-day cycles starting from Cycle 1 Day 1. Participants also received gilteritinib 120 mg QD as oral tablets in consecutive 28-day cycles starting from Cycle 1 Day 2. Participants received treatment until progression/relapse or lack of at least a PR after 6 months of study treatment, intolerance, or withdrawal from treatment by the participant or study investigator. |
| OG002 | LANRA 60 mg QD + Gilteritinib 120 mg QD | Participants received LANRA 60 mg QD as oral tablets in consecutive 28-day cycles starting from Cycle 1 Day 1. Participants also received gilteritinib 120 mg QD as oral tablets in consecutive 28-day cycles starting from Cycle 1 Day 2. Participants received treatment until progression/relapse or lack of at least a PR after 6 months of study treatment, intolerance, or withdrawal from treatment by the participant or study investigator. |
| OG003 | LANRA 90 mg QD + Gilteritinib 120 mg QD | Participants received LANRA 90 mg QD as oral tablets in consecutive 28-day cycles starting from Cycle 1 Day 1. Participants also received gilteritinib 120 mg QD as oral tablets in consecutive 28-day cycles starting from Cycle 1 Day 2. Participants received treatment until progression/relapse or lack of at least a PR after 6 months of study treatment, intolerance, or withdrawal from treatment by the participant or study investigator. |
|
| OG002 | LANRA 60 mg QD + Gilteritinib 120 mg QD | Participants received LANRA 60 mg QD as oral tablets in consecutive 28-day cycles starting from Cycle 1 Day 1. Participants also received gilteritinib 120 mg QD as oral tablets in consecutive 28-day cycles starting from Cycle 1 Day 2. Participants received treatment until progression/relapse or lack of at least a PR after 6 months of study treatment, intolerance, or withdrawal from treatment by the participant or study investigator. |
| OG003 | LANRA 90 mg QD + Gilteritinib 120 mg QD | Participants received LANRA 90 mg QD as oral tablets in consecutive 28-day cycles starting from Cycle 1 Day 1. Participants also received gilteritinib 120 mg QD as oral tablets in consecutive 28-day cycles starting from Cycle 1 Day 2. Participants received treatment until progression/relapse or lack of at least a PR after 6 months of study treatment, intolerance, or withdrawal from treatment by the participant or study investigator. |
|
|
| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
|