Trial Outcomes & Findings for GLAD-AML - Glasdegib (Pf-04449913) With Two Standard Decitabine Regimens for Older Patients With Poor-risk Acute Myeloid Leukemia (NCT NCT04051996)
NCT ID: NCT04051996
Last Updated: 2021-10-15
Results Overview
The complete remission (CR) and complete remission with incomplete count recovery (CRi) combined rate will be defined by the 2017 European LeukemiaNet (ELN) AML response criteria.
TERMINATED
PHASE2
1 participants
Up to 2 years
2021-10-15
Participant Flow
Participant milestones
| Measure |
DAC5
Glasdegib will be administered at the starting dose of 100 mg orally once daily and continuously in combination with either DAC5 (decitabine 20 mg/m2 IV on a 5-day schedule) or DAC10 (decitabine 20 mg/m2 IV on a 10-day schedule) as per randomization. Treatment will be administered in 28-day cycles.
Glasdegib: Glasdegib will be administered at the starting dose of 100 mg orally once daily.
Decitabine: Decitabine will be administered per local label and will be administered by IV infusion at a dose of 20 mg/m2/day for either 5 days or 10 days as determined by randomization. Each cycle will be every 28 days.
|
DAC10
Glasdegib will be administered at the starting dose of 100 mg orally once daily and continuously in combination with either DAC5 (decitabine 20 mg/m2 IV on a 5-day schedule) or DAC10 (decitabine 20 mg/m2 IV on a 10-day schedule) as per randomization. Treatment will be administered in 28-day cycles.
Glasdegib: Glasdegib will be administered at the starting dose of 100 mg orally once daily.
Decitabine: Decitabine will be administered per local label and will be administered by IV infusion at a dose of 20 mg/m2/day for either 5 days or 10 days as determined by randomization. Each cycle will be every 28 days.
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Overall Study
STARTED
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1
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0
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Overall Study
COMPLETED
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1
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0
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Overall Study
NOT COMPLETED
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0
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
GLAD-AML - Glasdegib (Pf-04449913) With Two Standard Decitabine Regimens for Older Patients With Poor-risk Acute Myeloid Leukemia
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: Up to 2 yearsPopulation: Only 1 patient was enrolled in the study prior to termination and therefore would be identified through presenting these characteristics.
The complete remission (CR) and complete remission with incomplete count recovery (CRi) combined rate will be defined by the 2017 European LeukemiaNet (ELN) AML response criteria.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Only 1 patient was enrolled in the study prior to termination and therefore would be identified through presenting these characteristics.
Overall survival (OS) is defined as the time from date of first study treatment to date of death due to any cause.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Only 1 patient was enrolled in the study prior to termination and therefore would be identified through presenting these characteristics.
Event-free survival (EFS) will be monitored up to 2 years.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Only 1 patient was enrolled in the study prior to termination and therefore would be identified through presenting these characteristics.
Relapse-free survival (RFS) will be monitored up to 2 years.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Only 1 patient was enrolled in the study prior to termination and therefore would be identified through presenting these characteristics.
The time to complete remission (CR) and complete remission with incomplete count recovery (CRi) will be collected as a secondary outcome.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Only 1 patient was enrolled in the study prior to termination and therefore would be identified through presenting these characteristics.
The duration of complete remission (CR) and complete remission with incomplete count recovery (CRi) will be collected as a secondary outcome.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Only 1 patient was enrolled in the study prior to termination and therefore would be identified through presenting these characteristics.
Bone marrow mutational clearance of frequently-mutated genes in AML (e.g. NPM1, CEBPA, DNMT3A, RUNX1, TET2, IDH1/2) via next-generation DNA sequencing will be monitored up to 2 years.
Outcome measures
Outcome data not reported
Adverse Events
DAC5
DAC10
Serious adverse events
| Measure |
DAC5
n=1 participants at risk
Glasdegib will be administered at the starting dose of 100 mg orally once daily and continuously in combination with either DAC5 (decitabine 20 mg/m2 IV on a 5-day schedule) or DAC10 (decitabine 20 mg/m2 IV on a 10-day schedule) as per randomization. Treatment will be administered in 28-day cycles.
Glasdegib: Glasdegib will be administered at the starting dose of 100 mg orally once daily.
Decitabine: Decitabine will be administered per local label and will be administered by IV infusion at a dose of 20 mg/m2/day for either 5 days or 10 days as determined by randomization. Each cycle will be every 28 days.
|
DAC10
Glasdegib will be administered at the starting dose of 100 mg orally once daily and continuously in combination with either DAC5 (decitabine 20 mg/m2 IV on a 5-day schedule) or DAC10 (decitabine 20 mg/m2 IV on a 10-day schedule) as per randomization. Treatment will be administered in 28-day cycles.
Glasdegib: Glasdegib will be administered at the starting dose of 100 mg orally once daily.
Decitabine: Decitabine will be administered per local label and will be administered by IV infusion at a dose of 20 mg/m2/day for either 5 days or 10 days as determined by randomization. Each cycle will be every 28 days.
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|---|---|---|
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Respiratory, thoracic and mediastinal disorders
Dyspnea
|
100.0%
1/1 • Number of events 1 • Up to 2 years
There was only 1 patient enrolled in the study before termination and therefore there was only 1 treatment arm utilized.
|
—
0/0 • Up to 2 years
There was only 1 patient enrolled in the study before termination and therefore there was only 1 treatment arm utilized.
|
|
Injury, poisoning and procedural complications
Acute Kidney Injury
|
100.0%
1/1 • Number of events 1 • Up to 2 years
There was only 1 patient enrolled in the study before termination and therefore there was only 1 treatment arm utilized.
|
—
0/0 • Up to 2 years
There was only 1 patient enrolled in the study before termination and therefore there was only 1 treatment arm utilized.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place