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Clinical Trial 20716

Cancer Type: Malignant Hematology
Study Type: Treatment
NCT#: NCT04313881

Phase: Phase III
Prinicipal Investigator: Sallman, David

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Overview

Study 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

Summary

The purpose of this study is to compare the effects, both good and bad, of magrolimab in combination with azacitidine, to those of azacitidine in combination with placebo, to find out which is better for treating patients with MDS.

Objective

The aim of this study is to evaluate the efficacy and safety of magrolimab + azacitidine compared to azacitidine + placebo in previously untreated patients with intermediate/high/very high risk MDS by IPSS-R prognostic risk categories.

Treatments

Therapies

Chemotherapy (NOS); Therapy (NOS)

Medications

Diphenhydramine (); Magrolimab/Placebo (); acetaminophen (); azacitidine (5-azacitidine)

Inclusion Criteria

> 18 years of age or older

  • Previously untreated individuals with intermediate to very high risk Myelodysplastic Syndrome (MDS) by Revised International Prognostic Scoring System (IPSS-R)
  • Adequate performance status and hematological, liver, and kidney function
  • Willing to undergo blood transfusions as deemed clinically necessary.
  • Pretreatment blood cross-match completed
  • Female patients of childbearing potential must be willing to use 1 highly effective method of contraception during the study and continue for 4 months after the last dose of study treatment
  • Male patients who are sexually active with a woman of childbearing potential (WOCBP) and who have not had vasectomies must be willing to use a barrier method of contraception (condom plus spermicidal gel) and refrain from sperm donation during the study and for 4 months after the last dose of study treatment. If the partner is pregnant, male patients must use barrier method contraception (condom) during the study and for 4 months after the last dose of study treatment to prevent fetal exposure to study treatment.
  • Willing to consent to mandatory pretreatment and on-treatment bone marrow biopsies (trephines), unless not feasible as determined by the Investigator and discussed with the Sponsor.
  • Other criteria may apply

  • Exclusion Criteria

    > Prior treatment with CD47 or SIRPα-targeting agents.

  • Any prior antileukemic therapy (excluding hydroxyurea or oral etoposide), prior treatment with hypomethylating agents and/or low dose cytarabine. NOTE: Localized non-central nervous system (CNS) radiotherapy, erythroid and/or myeloid growth factors, previous hormonal therapy with luteinizing hormone-releasing hormone (LHRH) agonists for prostate cancer, and treatment with bisphosphonates and receptor activator of nuclear factor kappa-B ligand (RANKL) inhibitors are not criteria for exclusion.
  • Contraindications to azacitidine, including advanced malignant hepatic tumors or known hypersensitivity to azacitidine or mannitol.
  • Known inherited or acquired bleeding disorders.
  • Previous SCT within 6 months prior to randomization, active graft-versus-host disease, or requiring transplant-related immunosuppression.
  • Clinical suspicion of active CNS involvement by MDS.
  • Significant medical diseases or conditions, as assessed by the Investigators and Sponsor, that would substantially increase the risk benefit ratio of participating in the study.
  • 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 as defined in Exclusion Criterion 2.
  • History of psychiatric illness or substance abuse likely to interfere with the ability to comply with protocol requirements or give informed consent.
  • Pregnancy or active breastfeeding.
  • Known active or chronic hepatitis B or C infection or human immunodeficiency virus.
  • Other exclusions apply

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