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Leukemia/MDS Clinical Trials

Showing 31-35 of 35 items
31.
  • Study of Orally Administered AG-120 in Subjects With Advanced Hematologic Malignancies With an IDH1 Mutation
  • The purpose of this Phase I, multicenter study is to evaluate the safety, pharmacokinetics, pharmacodynamics and clinical activity of AG-120 in advanced hematologic malignancies that harbor an IDH1 mutation. The first portion of the study is a dose escalation phase where cohorts of patients will receive ascending oral doses of AG-120 to determine maximum tolerated dose (MTD) and/or the recommended Phase II dose. The second portion of the study is a dose expansion phase where three cohorts of patients will receive AG-120 to further evaluate the safety, tolerability, and clinical activity of the MTD. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.
  • Diagnoses: Leukemia/MDS
  • Status: Recruiting
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  • Safety Study of AG-120 or AG-221 in Combination With Induction and Consolidation Therapy in Patients With Newly Diagnosed Acute Myeloid Leukemia With an IDH1 and/or IDH2 Mutation
  • The purpose of this Phase I, multicenter, clinical trial is to evaluate the safety of AG-120 and AG-221 when given in combination with standard AML induction and consolidation therapy. The study plans to evaluate 1 dose level of AG-120 in patients with an IDH1 mutation and 2 dose levels of AG-221 in patients with an IDH2 mutation. AG-120 or AG-221 will be administered with 2 types of AML induction therapies (cytarabine with either daunorubicin or idarubicin) and 2 types of AML consolidation therapies (mitoxantrone with etoposide [ME] or cytarabine). After consolidation therapy, patients may continue on maintenance therapy and receive daily treatment of AG-120 or AG-221 for up to 1 year from Day 1 of the first induction cycle, or until relapse, development of an unacceptable toxicity, or hematopoietic stem cell transplant (HSCT).
  • Diagnoses: Leukemia/MDS
  • Status: Recruiting
Showing 31-35 of 35 items
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