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Leukemia/MDS Clinical Trials

Showing 31-33 of 33 items
  • 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 four cohorts of patients will receive AG-120 to further evaluate the safety, tolerability, and clinical activity of the recommended Phase II dose. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.
  • Diagnoses: Leukemia/MDS
  • Status: Recruiting
  • Tipifarnib in Subjects With Transfusion-dependent, Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes
  • This two-stage study is designed to investigate the antitumor activity of tipifarnib in approximately 58 eligible subjects with very low, low or INT risk MDS who have no known curative treatment. Eligible subjects may have received no more than 2 prior systemic therapies. In the first stage, 44 eligible subjects will be enrolled and stratified in to one of four biomarker-defined strata (11 subjects per stratum) based on subject KIR2DS2 and KIR2DL2 positivity. Subjects will receive tipifarnib administered at a starting dose of 900 mg, orally with food, twice a day (bid) for 7 days in alternating weeks (Days 1-7 and 15-21) in 28 day cycles. At the discretion of the investigator, the dose of tipifarnib may be increased to 1200 mg bid if the subject has not experienced dose limiting toxicities at the 900 mg dose level. Determination of RBC tranfusion independence and disease response will be performed by the Investigator according to the MDS/MPN International Working Group (IWG) criteria. Similarly, disease progression will also be determined based on the MDS/MPN IWG criteria.
  • Diagnoses: Leukemia/MDS
  • Status: Recruiting
  • 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 31-33 of 33 items
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