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CompletedLast updated: 7 February 2024

ENHANCE: This phase III trial is testing the addition of a targeted therapy drug to treatment for previously untreated patients with intermediate-very high risk myelodysplastic syndromes (MDS)A Randomized, Double-blind, Multicenter Study Comparing Magrolimab in Combination With Azacitidine Versus Azacitidine Plus Placebo in Treatment-naïve Patients With Higher Risk Myelodysplastic Syndrome

Clinical summary

Summary

Eligible patients will be randomised to receive magrolimab or a magrolimab-placebo, with 75mg/m^2 azacitidine administered on Days 1 to 7 (or Days 1 to 5 and 8 to 9) of each cycle. Magrolimab will be administered via the following dosing regimens - Cycle 1: 1mg/kg priming dose on Days 1 and 4; 15 mg/kg on Day 8; and 30 mg/kg on Days 11, 15, and 22. Cycle 2: weekly doses of 30 mg/kg on Days 1, 8, 15, and 22. Cycle 3 and onward: 30 mg/kg every 2 weeks on Days 1 and 15.

Conditions

This trial is treating patients with myelodysplastic syndrome

Cancer

Blood Cancers Haematological

Age

People18+

Phase

III

Trial Acronym

ENHANCE

More information

Trial Identifiers

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Trial sponsor

Gilead Sciences, Inc.

Scientific Title

A Randomized, Double-blind, Multicenter Study Comparing Magrolimab in Combination With Azacitidine Versus Azacitidine Plus Placebo in Treatment-naïve Patients With Higher Risk Myelodysplastic Syndrome

Eligibility

Inclusion

  • Participants with Myelodysplastic Syndrome (MDS) defined according to World Health Organization classification, with Revised International Prognostic Scoring System (IPSS-R) prognostic risk category of intermediate, high, or very high risk.
  • Adequate performance status and hematological, liver, and kidney function

Exclusion

  • Immediate eligibility for allogenic stem cell transplant (SCT), as determined by the investigator, with an available donor
  • Prior treatment with Cluster of Differentiation (CD) 47 or Signal-regulatory protein alpha (SIRPα)-targeting agents
  • Any prior antileukemic therapy for treatment of intermediate, high, very high risk MDS per IPSS-R
  • Second malignancy, except treated basal cell or localized squamous skin carcinomas, localized prostate cancer, or other malignancies for which participants are not on active anticancer therapies and have had no evidence of active malignancy for at least ≥ 1 year
  • Contraindications to azacitidine
  • Clinical suspicion of active central nervous system (CNS) involvement by MDS
  • Known active or chronic hepatitis B or C infection or human immunodeficiency virus in medical history
  • Active hepatitis B virus and/or active hepatitis C virus, and/or HIV following testing at screening
  • Pregnancy or active breastfeeding

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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