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Protocol # 21-374

Status

Recruiting

Description

The primary objective of this study is to compare the efficacy of magrolimab + azacitidine versus venetoclax + azacitidine in adults with previously untreated TP53 mutant acute myeloid leukemia (AML) who are appropriate for non-intensive therapy as measured by overall survival (OS).

Condition

  • Acute Myeloid Leukemia

Interventions

  • Magrolimab
  • Venetoclax
  • Azacitidine
  • Cytarabine
  • Daunorubicin
  • Idarubicin
  • Steroidal Eye Drops

Phase

Phase 3

Study Type

Interventional

Further Study Details

Primary Outcome:

  • Overall Survival (OS) in Participants Appropriate for Non-intensive Therapy

Secondary Outcome:

  • Overall Survival in All Participants
  • Event-Free Survival (EFS) in All Participants
  • Transfusion Independence Conversion Rate in All Participants
  • Rate of Complete Remission (CR) in All Participants
  • Rate of CR Without Minimal Residual Disease (CR MRD-) in All Participants
  • Time Until Meaningful Definitive Deterioration (TUDD) on the EORTC QLQ-C30 GHS/QoL Scale in All Participants
  • TUDD on the EORTC QLQ-C30 Physical Functioning Scale in All Participants
  • Rate of CR and Complete Remission with Partial Hematologic Recovery (CR+CRh) in All Participants
  • Duration of Complete Remission (DCR)
  • Duration of CR+CRh
  • 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
  • Serum Concentration of Magrolimab
  • Rate of Anti-Magrolimab Antibody Incidence

Enrollment

346

Study Start Date

July 1, 2021

Eligibility

  • Gender:     All
  • Minimum age:     18 Years
  • Maximum age:     N/A
  • Healthy volunteers:     No

Sponsors

Gilead Sciences

Source

Gilead Sciences

Official title

A Phase 3, Randomized, Open-Label Study Evaluating 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 Patients With TP53 Mutant Acute Myeloid Leukemia

Clinicaltrials.gov Identifier

NCT04778397

     

Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.