Clinical trials are an important way to improve treatment for people with cancer. While most are continuing during the COVID-19 pandemic, the period of time that clinical trials are available and recruiting may change quickly. If you would like to get involved in a clinical trial, speak to your treatment team or the health service where the clinical trial is being undertaken, to confirm it is open and appropriate for you. For cancer information and support, call Cancer Council's experienced cancer nurses on 13 11 20 Monday to Friday from 9am-5pm.

ENHANCE-2 : 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

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

ThreePhase Three

18+Age Over 18

Blood<br/>CancersCancer LocationBlood
Cancers

Systemic therapy | Blood / Myeloma / LymphomaAcute Myeloid Leukaemia

Trial Overview Read MoreRead more

This phase III trial is comparing the effectiveness of three different treatments in people with previously untreated, TP53 mutant, acute myeloid leukaemia: a new targeted therapy (magrolimab) combined with a hypomethylating agent which reduces the number of abnormal blood cells (azacitidine); a different targeted therapy (venetoclax) combined with the hypomethylating agent (azacitidine); and an intensive chemotherapy regimen (including cytarabine, and daunorubicin or idarubicin).
 

This trial is treating patients with TP53 Mutant Acute Myeloid Leukaemia.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You are able to swallow medication by mouth.
  • You have been diagnosed with cancer, but have not received any treatment.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific 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

Commercial Sponsor

Gilead Sciences, Inc.

Summary

This is a randomised, open-label trial with one Experimental Arm and two Active Comparator Arms. In the Experimental Arm, participants will receive an escalating dose of magrolimab (administered intravenously [via IV]) and a fixed dose of azacitidine (administered either via an injection or via IV, 75mg/m^2 on Days 1-7 or Days 1-5,8 and 9 during every cycle). The first Active Comparator Arm will consist of participants who are appropriate for non-invasive therapy. They will receive an escalating dose of venetoclax (administered orally, 100mg on Day 1, 200mg on Day 2, 400mg on Days 3-28 during Cycle 1, followed by 400mg on Days 1-28 during every cycle thereafter), and a fixed dose of azacitidine (administered the same as in the Experimental Arm). The second Active Comparator Arm will consist of participants who are appropriate for intensive therapy. They will receive 7+3 chemotherapy: 7 day treatment with cytarabine and a 3 day treatment with daunorubicin or idarubicin during induction and high-dose cytarabine and steroidal eye drops during consolidation. Cytarabine will be administered (during induction) as a continuous infusion, 100 or 200mg/m^2 on Days 1-7 (7+3 induction) and if needed Days 1-5 (5+2 induction) during a cycle. Cytarabine will be administered (during consolidation) via IV, 3000mg/m^2 on Days 1, 3 and 5 once every 12 hours for up to 4 cycles. Daunorubicin will be administered via IV peripherally, 60mg/m^2 on Days 1-3 (7+3 induction) and if needed Days 1-2 (5+2 induction) during a cycle. Idarubicin will be administered via IV, 12mg/m^2 on Days 1-3 (7+3 induction) and if needed Days 1-2 (5+2 induction) during a cycle.

Recruiting Hospitals Read MoreRead more

Alfred Hospital, Malignant Haematology & Stem Cell Transplantation Service
Prahran
Ms Mary Lane
m.lane@alfred.org.au
03 9076 5281

Barwon Health, University Hospital Geelong
Geelong
Haematology Team
HaematologyTrials@barwonhealth.org.au

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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