Study of Magrolimab in Combination With Azacitidine Versus Physician's Choice of Venetoclax in Combination With Azacitidine or Intensive Chemotherapy in Patients With TP53 Mutant Acute Myeloid Leukemia That Have Not Been Treated

Conditions

• Acute Myeloid Leukemia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Magrolimab — DRUG
  Administered intravenously (IV).
• Venetoclax — DRUG
  Administered orally at a dose of 100 milligrams (mg) on Day 1, 200 mg on Day 2, 400 mg on Days 3-28 during Cycle 1, followed by 400 mg on Days 1-28 during every cycle (Cycle=28 days).
• Azacitidine — DRUG
  Administered either subcutaneously (SC) or IV, 75 milligrams per square meter (mg/m\^2) on Days 1-7 or Days 1-5, 8 and 9 during every cycle (Cycle=28 days).
• Cytarabine — DRUG
  Induction: administered continuous infusion, 100 or 200 mg/m\^2 on Days 1-7 (7+3 induction) and if needed Days 1-5 (5+2 induction) during a cycle (Cycle=Up to 42 Days). Consolidation: administered IV, 1500 or 3000 mg/m\^2 on Days 1, 3, and 5 once every 12 hours for up to 4 cycles.
• Daunorubicin — DRUG
  Administered IV peripherally (IVP), 60 mg/m\^2 on Days 1-3 (7+3 induction) and if needed Days 1-2 (5+2 induction) during a cycle (Cycle=Up to 42 days).
• Idarubicin — DRUG
  Administered IV, 12 mg/m\^2 on Days 1-3 (7+3 induction) and if needed Days 1-2 (5+2 induction) during a cycle (Cycle=Up to 42 days).
• Steroidal Eye Drops — DRUG
  Administered per institutional standard during consolidation.

Study Details

The goal of this clinical study is to compare the effectiveness of the study drugs, magrolimab in combination with azacitidine, versus venetoclax in combination with azacitidine in participants with previously untreated TP53 mutant acute myeloid leukemia (AML).

Key Dates

Start date

Jul 1, 2021

Status verified

Feb 2025

Primary completion

Mar 25, 2024

Completion

Mar 25, 2024

Study Design

Enrollment

258 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Magrolimab + Azacitidine
  Participants will receive an escalating dose of magrolimab and a fixed dose of azacitidine.
• Active Comparator: Control Arm: Venetoclax + Azacitidine
  Participants who are appropriate for non-intensive therapy will receive an escalating dose of venetoclax and a fixed dose of azacitidine.
• Active Comparator: Control Arm: 7+3 Chemotherapy
  Participants who are appropriate for intensive therapy will receive 7+3 chemotherapy: 7 day treatment with cytarabine and 3 day treatment with daunorubicin or idarubicin during induction and high-dose cytarabine and steroidal eye drops during consolidation.

Primary Outcome Measure

Overall Survival (OS) in Participants Appropriate for Non-intensive Therapy [ Time Frame: Up to 2.1 years ]

Locations (36)

Find similar trials in Birmingham, AL

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