|Closed||Acute Myeloid Leukemia (AML)||Phase II||
RATIONALE: Drugs used in chemotherapy, such as alvocidib, cytarabine, and mitoxantrone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. It is not yet known which schedule of alvocidib is more effective when given together with cytarabine and mitoxantrone in treating patients with acute myeloid leukemia.
PURPOSE: This randomized phase II trial is studying two different schedules of alvocidib to compare how well they work when given together with cytarabine and mitoxantrone in treating patients with newly diagnosed acute myeloid leukemia.
|Ages Eligible for Study:||18 Years and older|
|Genders Eligible for Study:||Both|
|Accepts Healthy Volunteers:||No|
Pathologically confirmed newly diagnosed acute myeloid leukemia (AML) meeting the following criteria:
Subtypes M0, M1, M2, M4-7
- No acute promyelocytic leukemia (M3)
At least 50 years of age OR ≥ 18 years of age with ≥ 1 of the following poor-risk disease features:
- Antecedent hematologic disorder, including myelodysplastic syndromes (MDS)-related AML or prior myeloproliferative disorder (MPD)
- Treatment-related myeloid neoplasm (t-AML/t-MDS)
- Myeloid sarcoma, myeloid proliferations related to Down Syndrome, or blastic plasmacytoid dendritic cell neoplasm
- AML with trilineage dysplasia
- AML with adverse cytogenetics (defined as -5/-5q; -7/-7q; abnormal 3q, 9q, 11q, 20q, 21q, or 17p; t[6;9]; t[9;22]; trisomy 8; trisomy 13, complex karyotypes [≥ 3 unrelated abnormalities])
- No hyperleukocytosis with ≥ 50,000 blasts/uL (leukapheresis or hydroxyurea allowed for cytoreduction immediately prior to the first dose of alvocidib)
- No active CNS leukemia
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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