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

NOT ENROLLING
Protocol # :
20-363
Conditions
Myelodysplastic Syndromes
Phase
III
Disease Sites
Other Hematopoietic
Principal Investigator
DeAngelo, Daniel, J
Site Research Nurses
Ramos, Aura
Som, Tina
Vartanian, Megan

Trial Description

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).

Eligibility Requirements

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.

20-363