drugset / Trial / NCT01424982

Combination Chemotherapy and Ponatinib Hydrochloride in Treating Patients With Acute Lymphoblastic Leukemia

NCT01424982

Phase 2 Active not recruiting 88 enrolled M.D. Anderson Cancer Center
NaSingle-groupOpen-labelTreatment

Summary

This phase II trial studies the side effects and how well combination chemotherapy and ponatinib hydrochloride work in treating patients with acute lymphoblastic leukemia. Drugs used in chemotherapy, such as cyclophosphamide, vincristine sulfate, doxorubicin hydrochloride, and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Ponatinib hydrochloride may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving combination chemotherapy and ponatinib hydrochloride may be an effective treatment for acute lymphoblastic leukemia.

Timeline

Start
2011-10-05
Primary completion
2027-10-31
Completion
2027-10-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Ponatinib Small molecule 15 mg Oral
Subject Ponatinib Small molecule 30 mg Oral
Subject Ponatinib Small molecule 45 mg Oral
Background Cyclophosphamide Other / unclassified Intravenous
Background Cytarabine Small molecule Intravenous
Background Dexamethasone Small molecule Intravenous
Background Doxorubicin Other / unclassified Intravenous
Background Methotrexate Small molecule Intravenous
Background Prednisone Other / unclassified 200 mg Oral
Background Rituximab Monoclonal antibody Intravenous
Background Vincristine Small molecule 2 mg Intravenous