Magrolimab + Azacitidine Versus Azacitidine + Placebo in Untreated Participants With Myelodysplastic Syndrome (MDS)

Trial ID or NCT#

NCT04313881

Status

not recruiting iconNOT RECRUITING

Purpose

The primary objective of this study is to evaluate the efficacy of magrolimab in combination with azacitidine compared to that of azacitidine plus placebo in previously untreated participants with intermediate/high/very high risk myelodysplastic syndrome (MDS) by Revised International Prognostic Scoring System (IPSS-R) as measured by complete remission (CR) and overall survival (OS).

Official Title

ENHANCE: 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 Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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 Key
Exclusion Criteria:
  1. - 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.
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Investigator(s)

Peter Greenberg
Peter Greenberg
Hematologist-Oncologist
Professor of Medicine (Hematology), Emeritus

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Contact

Jack Taw
650-723-2781

View on ClinicalTrials.gov