drugset
drugset / Trial / NCT00795002

Alvocidib, Cytarabine, and Mitoxantrone in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia

NCT00795002 ↗

Phase 2 Completed 78 enrolled National Cancer Institute (NCI)
RandomizedParallel-groupOpen-labelTreatment

Summary

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. 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.

Timeline

Start
2008-11
Primary completion
2010-11
Completion
2012-09

Drugs

EvaluationDrugModalityDoseRoute
Subject alvocidib Small molecule — Intravenous
Background Cytarabine Small molecule — Intravenous
Background Mitoxantrone Small molecule — Intravenous

Indications

acute erythroid leukemia acute megakaryoblastic leukemia in adult acute myeloblastic leukemia with maturation acute myeloblastic leukemia without maturation acute myeloid leukemia with 11q23 abnormalities acute myeloid leukemia with abnormal bone marrow eosinophils inv(16)(p13q22) or t(16;16)(p13;q22) acute myeloid leukemia with minimal differentiation acute myeloid leukemia with multilineage dysplasia acute myeloid leukemia with t(8;21)(q22;q22) translocation acute myeloid leukemia, del(5q31-q32) acute myeloid leukemia, t(16;16)(p13.1;q22) acute myelomonocytic leukemia M4 adult acute monocytic leukemia