Flavopiridol in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, or Chronic Myelogenous Leukemia

Stopped early · Phase 1

Conditions studied: Adult Acute Basophilic Leukemia, Adult Acute Eosinophilic Leukemia, Adult Acute Megakaryoblastic Leukemia (M7), Adult Acute Minimally Differentiated Myeloid Leukemia (M0), Adult Acute Monoblastic Leukemia (M5a), Adult Acute Monocytic Leukemia (M5b), Adult Acute Myeloblastic Leukemia With Maturation (M2), Adult Acute Myeloblastic Leukemia Without Maturation (M1), Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Adult Acute Myelomonocytic Leukemia (M4), Adult Erythroleukemia (M6a), Adult Pure Erythroid Leukemia (M6b), Blastic Phase Chronic Myelogenous Leukemia, Recurrent Adult Acute Lymphoblastic Leukemia, Recurrent Adult Acute Myeloid Leukemia, Relapsing Chronic Myelogenous Leukemia

In brief

This phase I trial is studying the side effects and best dose of flavopiridol in treating patients with relapsed or refractory acute myeloid leukemia, acute lymphoblastic leukemia, or chronic myelogenous leukemia. Drugs used in chemotherapy, such as flavopiridol, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.

Key facts

Study ID

NCT00101231

Run by

National Cancer Institute (NCI)

People needed

88

Starts

2004-10-01

Last updated by the study team

2013-06-04

Who can join

Age: 1 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed diagnosis of one of the following:
• Acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) meeting 1 of the following criteria:
• Refractory to initial treatment (stratum 1)
• Recurrent disease after prior high-dose chemotherapy with or without stem cell support (stratum 1)
• High-risk refractory disease defined as failed ≥ 2 regimens for remission induction (i.e., twice induction failure) (stratum 2)
• High-risk relaspsed disease defined as disease in second or greater bone marrow relapse (stratum 2)
• Chronic myelogenous leukemia in blast crisis (stratum 1)
• Myeloid or lymphoid blast crisis that did not respond to or progressed after prior high-dose imatinib mesylate (600-800 mg/day for ≥ 2 weeks)
• No acute promyelocytic leukemia
• Ineligible for or unwilling to undergo potentially curative allogeneic or autologous stem cell transplantation
• Patients with relapsed AML that is refractory to re-induction therapy comprising an active, intensive salvage regimen are eligible
• CNS involvement allowed provided there are no residual leukemic cells in the cerebrospinal fluid after intrathecal chemotherapy or radiotherapy
• Performance status - ECOG ≥ 2 for patients > 10 years of age
• Performance status - Lansky 50-100% for patients ≤ 10 years of age
• At least 8 weeks
• Bilirubin ≤ 2 times upper limit of normal (ULN)* (unless due to Gilbert's syndrome)
• ALT and AST ≤ 5 times ULN*
• Creatinine ≤ 2.0 mg/dL* (stratum 1)
• Creatinine > 1.3 times ULN (stratum 2)
• LVEF ≥ 40% by echocardiogram or MUGA (stratum 1)
• Shortening fraction ≥ 28% by echocardiogram (stratum 2)
• No symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia
• Not pregnant or nursing

Where it is running

• Ohio State University Medical Center — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.