A Randomized, Double Blind, Multicenter Study Comparing Magrolimab in Combination with Azacitidine versus Azacitidine plus Placebo in Treatment-naive Patients with Higher Risk Myelodysplastic Syndrome
Dr. Carolyn Grove
This trial is for untreated patients with intermediate to high-risk myelodysplastic syndrome (MDS). Patients will be allocated into one of two arms by chance. In the experimental arm, patients will receive the study drug magrolimab and azacitidine. Magrolimab is a monoclonal antibody that activates immune cells to identify and destroy cancer cells. Azacitidine is a drug that switches off a protein that turns on genes to stop cancer cells from growing. Patients in the control arm will receive azacitidine and a placebo medication.
- Previously untreated patients with MDS with an IPSS-R prognostic risk category of intermediate, high or very high risk.
- Prior and concurrent therapy with hydroxyurea, oral etoposide, erythroid and/or myeloid growth factors is allowed.
- Male or female aged 18 years or above.
- ECOG performance of 0-2.
- Prior treatment with Cluster of Differentiation (CD) 47 or Signal-regulatory protein
- alpha (SIRPα)-targeting agents
- Any prior antileukemic therapy
- Contraindications to azacitidine
- Second malignancy, except treated basal cell or localized squamous skin carcinomas, localized prostate cancer or other malignancies for which patients are not on active anticancer therapy
- Clinical suspicion of active central nervous system involvement by MDS
- Pregnancy or active breastfeeding
- Known active or chronic hepatitis B or C infection or human immunodeficiency virus.