Magrolimab + Azacitidine Versus Azacitidine + Placebo in Untreated Participants With Myelodysplastic Syndrome (MDS)
- Interventional
- Recruiting
- NCT04313881
Contact Information
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
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).
Gender
All
Age Group
18 Years and up
Accepting Healthy Volunteers?
No
Key Inclusion Criteria:
- 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:
- 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.
- 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:
- 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.