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A Phase 3, Randomized, Open-Label Study Evaluating the Safety and Efficacy of Magrolimab in Combination With Azacitidine Versus Physician's Choice of Venetoclax in Combination With Azacitidine or Intensive Chemotherapy in Previously Untreated Patients With TP53 Mutant Acute Myeloid Leukemia (ENHANCE-2)
Rochester, Minn.,
Jacksonville, Fla.
The primary objective of this study is to compare the effectiveness of magrolimab + azacitidine versus venetoclax + azacitidine in adults with previously untreated TP53 mutant acute myeloid leukemia (AML) who are appropriate for non-intensive therapy as measured by overall survival (OS).
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MC200805, Phase II Study to Determine the Efficacy and Safety of Luspatercept (ACE-536) in Patients with Myelodysplastic/Myeloproliferative Neoplasms with Ring Sideroblasts and Thrombocytosis (MDS/MPN-RS-T) and Myelodysplastic/Myeloproliferative Neoplasms, Unclassifiable with Ring Sideroblasts (MDS/MPN-U with RS)
Rochester, Minn.,
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to document the erythroid response rate assessed as per the 2015 International Working Group (IWG) MDS/MPN response criteria.
In this study we want to find out more about the side effects of a new drug combination for MDS/MPN-RS-T and MDS/MPN-U with RS, luspatercept with or without hydroxyurea and what doses of this combination are safe for people to take and how the disease responds to the treatment. There are 2 groups of patients being studied in this trial. One group of patients will receive luspatercept. The other group will receive luspatercept and hydroxyurea. Your study doctor will let you know which group you will be in. Your study doctor may also ask you to take aspirin
Luspatercept is approved by the U.S. Food and Drug Administration (FDA) for patients with anemia who require RBC blood transfusions with very low- to intermediate-risk MDS-RS or with MDS/MPN-RS-T. Hydroxyurea is FDA approved for treatment of resistant chronic myeloid leukemia. Aspirin is the current recommended treatment for risk of cardiac events such as stroke and heart attacks, and to stop blood clots from forming. This drug combination is still experimental and isn’t approved by the U.S. Food and Drug Administration (FDA). However, the FDA has allowed the use of this drug combination in this research study.
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