drugset
drugset / Trial / NCT00666588

Bortezomib and Combination Chemotherapy in Treating Younger Patients With Recurrent, Refractory, or Secondary Acute Myeloid Leukemia

NCT00666588 ↗

Phase 2 Completed 52 enrolled National Cancer Institute (NCI)
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This phase II trial is studying the side effects and best dose of bortezomib and to see how well it works when given together with combination chemotherapy in treating younger patients with recurrent, refractory, or secondary acute myeloid leukemia (AML). Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as idarubicin, cytarabine, and etoposide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) together with bortezomib may kill more cancer cells

Timeline

Start
2008-04
Primary completion
2012-12
Completion
2012-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Bortezomib Small molecule 1 mg/m2 Intravenous
Subject Bortezomib Small molecule 1.3 mg/m2 Intravenous
Subject Cytarabine Small molecule 30 mg Intravenous
Subject Cytarabine Small molecule 50 mg Intravenous
Subject Cytarabine Small molecule 70 mg Intravenous
Subject Cytarabine Small molecule 100 mg/m2 Intravenous
Subject Cytarabine Small molecule 1000 mg/m2 Intravenous
Background Etoposide Small molecule 150 mg/m2 Intravenous
Background Idarubicin Small molecule 12 mg/m2 Intravenous

Indications

acute basophilic leukemia acute erythroid leukemia acute myeloblastic leukemia with maturation acute myeloblastic leukemia without maturation acute myeloid leukemia with 11q23 abnormalities acute myeloid leukemia with minimal differentiation acute myeloid leukemia, del(5q31-q32) acute myeloid leukemia, t(16;16)(p13.1;q22) acute myelomonocytic leukemia M4 adult acute monocytic leukemia childhood acute megakaryoblastic leukemia childhood acute myeloid leukemia