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-3 : A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Magrolimab Versus Placebo in Combination With Venetoclax and Azacitidine in Newly Diagnosed, Previously Untreated Patients With Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy

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,Treatment | Blood / Myeloma / LymphomaAcute Myeloid Leukaemia

Trial Overview Read MoreRead more

This phase III study is trying to understand the effectiveness of immunotherapy (magrolimab) versus placebo, in combination with targeted therapy and chemotherapy (venetoclax and azacitidine) in people with newly diagnosed, previously untreated acute myeloid leukaemia.
 

This trial is treating patients with 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.

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, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Magrolimab Versus Placebo in Combination With Venetoclax and Azacitidine in Newly Diagnosed, Previously Untreated Patients With Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy

Commercial Sponsor

Gilead Sciences, Inc.

Summary

Eligible participants will be randomly allocated to either the Experimental Arm or the Placebo Comparator Arm. In the Experimental Arm, participants will receive magrolimab + venetoclax + azacitidine. Magrolimab will be administered intravenously at a dose of 1mg/kg priming dose on Days 1 and 4; 15mg/kg on Day 8; and 30mg/kg on Days 11, 15 and then every week for 5 doses and every 2 weeks after that. Venetoclax will be administered orally at a dose of 100mg on Cycle 1 Day 1, 200mg on Cycle 1 Day 2, 400mg on Cycle 1 Day 3 and daily after that. Azacitidine will be administered either subcutaneously or intravenously, at a dose of 75mg/m^2 on Days 1-7 or Days 1-5 and 8-9 of each cycle. Each cycle is 28 days. In the Placebo Comparator Arm, participants will receive a magrolimab placebo + venetoclax + azacitidine. Magrolimab placebo will be given intravenously on Days 1, 4, 8, 11 and 15, then every week for 5 doses and every 2 weeks after that. Venetoclax and Azacitidine will be administered the same as in the Experimental Arm.

Recruiting Hospitals Read MoreRead more

Border Medical Oncology
Albury
Ms Kate Oates
koates@bordermedonc.com.au
02 6064 1499

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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