Flavopiridol and Vorinostat in Treating Patients With Relapsed or Refractory Acute Leukemia or Chronic Myelogenous Leukemia or Refractory Anemia
Blastic Phase Chronic Myelogenous Leukemia, Recurrent Adult Acute Lymphoblastic Leukemia, Recurrent Adult Acute Myeloid Leukemia
About this trial
This is an interventional treatment trial for Blastic Phase Chronic Myelogenous Leukemia
Eligibility Criteria
Inclusion Criteria: Diagnosis of one of the following: Relapsed or refractory acute leukemia (acute myeloid leukemia [AML], acute lymphoblastic leukemia [ALL], or acute leukemia unclassifiable) following at least one prior systemic treatment Acute leukemia in a patient 60 years or older (no requirement for prior treatment) Acute leukemia that has evolved from a prior myelodysplastic syndrome Chronic myelogenous leukemia (CML) in blast crisis following prior imatinib mesylate therapy Refractory anemia with excess blasts-2 (RAEB-2) No known CNS leukemia ECOG performance status 0-2 WBC < 50,000µL Hydroxyurea and/or leukaphereses may be used to lower WBC Creatinine =< 1.5 times upper limit of normal (ULN) OR creatinine clearance >= 50 mL/min Total bilirubin =< 2 times ULN AST/ALT =< 2.5 times ULN QTc interval =< 0.470 seconds Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after study participation No other condition that would preclude study participation At least 3 weeks since prior treatment (expect leukaphereses) No valproic acid therapy within the past 2 weeks No prior autologous or allogeneic bone marrow or stem cell transplantation No hydroxyurea use within the past 24 hours No concurrent treatment with other anti-cancer agents or investigational agents
Sites / Locations
- Virginia Commonwealth University
Arms of the Study
Arm 1
Experimental
Arm I
Patients will receive a 1-hour infusion of flavopiridol on 5 days in week 1 and vorinostat by mouth three times a day in weeks 1 and 2. Treatment may repeat every 3 weeks for as long as benefit is shown.