Study Summary
This trial will compare the effectiveness of two different combinations of drugs for people with a certain type of leukemia who are not healthy enough for intensive treatment. The goal is to see which combination leads to better overall survival rates.
Eligible Conditions
- Acute Myeloid Leukemia
Treatment Effectiveness
Effectiveness Progress
This is further along than 85% of similar trials
Study Objectives
1 Primary · 16 Secondary · Reporting Duration: First CR or CRh achieved within 6 months for the Magrolimab + Azacitidine; Control Arm: Venetoclax + Azacitidine arm, and 2 months for Control Arm: 7+3 Chemotherapy up to the end of study (up to 27 months)
Month 6
Neoplasm, Residual
Rate of CR and Complete Remission with Partial Hematologic Recovery (CR+CRh) in All Participants
Rate of Complete Remission (CR) in All Participants
Month 24
TUDD on the EORTC QLQ-C30 Physical Functioning Scale in All Participants
Time Until Meaningful Definitive Deterioration (TUDD) on the EORTC QLQ-C30 GHS/QoL Scale in All Participants
Month 27
Duration of Complete Remission (DCR)
Month 27
Duration of CR+CRh
Month 24
Platelet Transfusion Independence Conversion Rate in All Participants
Red Blood Cell (RBC) Transfusion Independence Conversion Rate in All Participants
Transfusion Independence Conversion Rate in All Participants
Month 24
Percentage of Participants Experiencing Grade ≥ 3 Treatment-Emergent Adverse Events (TEAEs) According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0
Percentage of Participants Experiencing Grade ≥ 3 Treatment-Emergent Laboratory Abnormalities According to the NCI CTCAE Version 5.0
Month 27
Overall Survival (OS) in Participants Appropriate for Non-intensive Therapy
Overall Survival in All Participants
Month 27
Event-Free Survival (EFS) in All Participants
Month 24
Rate of Anti-Magrolimab Antibody Incidence
Month 24
Serum Concentration of Magrolimab
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Trial Design
3 Treatment Groups
Control Arm: Venetoclax + Azacitidine
1 of 3
Control Arm: 7+3 Chemotherapy
1 of 3
Magrolimab + Azacitidine
1 of 3
Active Control
Experimental Treatment
346 Total Participants · 3 Treatment Groups
Primary Treatment: Azacitidine · No Placebo Group · Phase 3
Magrolimab + AzacitidineExperimental Group · 2 Interventions: Azacitidine, Magrolimab · Intervention Types: Drug, Biological
Control Arm: Venetoclax + AzacitidineActiveComparator Group · 2 Interventions: Azacitidine, Venetoclax · Intervention Types: Drug, Drug
Control Arm: 7+3 ChemotherapyActiveComparator Group · 4 Interventions: Cytarabine, Daunorubicin, Steroidal Eye Drops, Idarubicin · Intervention Types: Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Azacitidine
FDA approved
Magrolimab
Not yet FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: first cr or crh achieved within 6 months for the magrolimab + azacitidine; control arm: venetoclax + azacitidine arm, and 2 months for control arm: 7+3 chemotherapy up to the end of study (up to 27 months)
Who is running the clinical trial?
Gilead SciencesLead Sponsor
1,016 Previous Clinical Trials
659,595 Total Patients Enrolled
Gilead Study DirectorStudy DirectorGilead Sciences
320 Previous Clinical Trials
180,630 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You are eligible for this study if you are 18 years or older, have a white blood cell count of 20×10^3/μL or less, and have not received a blood transfusion within the previous 30 days.
You have a hemoglobin level of ≥ 9 g/dL prior to initial dose of study treatment.
You are willing and able to comply with clinic visits and procedure outlined in the study protocol.
You have no congestive heart failure and no ischemic heart disease.
You have a left ventricular ejection fraction of at least 50% for individuals appropriate for intensive therapy.
Aspartate aminotransferase (AST) is between 3.0 and 10.
References
- Daver N, Vyas P, Kambhampati S, Malki MA, Larson R, Asch A, Mannis G, Chai-Ho W, Tanaka T, Bradley T, Jeyakumar D, Wang E, Xing G, Chao M, Ramsingh G, Renard C, Lal I, Zeidner J, Sallman D. AML-464 Tolerability and Efficacy of the First-In-Class Anti-CD47 Antibody Magrolimab Combined With Azacitidine in Frontline Patients With TP53-Mutated Acute Myeloid Leukemia (AML): Phase 1b Results. Clin Lymphoma Myeloma Leuk. 2022 Oct;22 Suppl 2:S253-S254. doi: 10.1016/S2152-2650(22)01300-3.
- 2021. "Study to Evaluate the Safety and Efficacy of Magrolimab in Combination With Azacitidine Versus Physician's Choice of Venetoclax in Combination With Azacitidine or Intensive Chemotherapy in Previously Untreated Adults With TP53 Mutant Acute Myeloid Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04778397.
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Conditions
Cancer Related
Treatments