drugset
drugset / Trial / NCT01839240

Azacitidine, Cytarabine, and Mitoxantrone Hydrochloride in Treating Patients With High-Risk Acute Myeloid Leukemia

NCT01839240 ↗

Phase 1 Completed 50 enrolled University of Chicago National Cancer Institute (NCI) · collab
NaSingle-groupOpen-labelTreatment

Summary

This phase I trial studies the side effects and best dose of azacitidine when given together with cytarabine and mitoxantrone hydrochloride in treating patients with high-risk acute myeloid leukemia. Drugs used in chemotherapy, such as azacitidine, cytarabine, and mitoxantrone hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Azacitidine may also help cytarabine and mitoxantrone hydrochloride work better by making the cancer cells more sensitive to the drugs

Timeline

Start
2012-06-06
Primary completion
2019-08-16
Completion
2019-08-16

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Azacitidine Other / unclassified 37.5 mg/m2 Intravenous
Subject Azacitidine Other / unclassified 50 mg/m2 Intravenous
Subject Azacitidine Other / unclassified 75 mg/m2 Intravenous
Background Cytarabine Small molecule 3000 mg/m2 Intravenous
Background Mitoxantrone Small molecule 30 mg/m2 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 t(8;21)(q22;q22) translocation acute myeloid leukemia, del(5q31-q32) acute myeloid leukemia, inv(16)(p13.1;q22) acute myeloid leukemia, t(16;16)(p13.1;q22) acute myelomonocytic leukemia M4 adult acute monocytic leukemia