drugset / Trial / NCT03147612

Low-Intensity Chemotherapy, Ponatinib and Blinatumomab in Treating Patients With Philadelphia Chromosome-Positive and/or BCR-ABL Positive Acute Lymphoblastic Leukemia

NCT03147612

Phase 2 Active not recruiting 22 enrolled M.D. Anderson Cancer Center
NaSingle-groupOpen-labelTreatment

Summary

This phase II trial studies how well low-intensity chemotherapy and ponatinib work in treating patients with Philadelphia chromosome-positive and/or BCR-ABL positive acute lymphoblastic leukemia that may have come back or is not responding to treatment. Drugs used in chemotherapy, such as cyclophosphamide, vincristine, dexamethasone, methotrexate, and cytarabine, 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. Immunotherapy with rituximab and blinatumomab, may induce changes in body's immune system and may interfere with the ability of cancer cells to grow and spread. Ponatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Granulocyte colony stimulating factor helps the bone marrow make recover after treatment. Giving low-intensity chemotherapy, ponatinib, and blinatumomab may work better in treating patients with acute lymphoblastic leukemia.

Timeline

Start
2018-02-08
Primary completion
2027-02-28
Completion
2027-02-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Blinatumomab Monoclonal antibody
Subject Ponatinib Small molecule Oral
Background Cyclophosphamide Other / unclassified Intravenous
Background Cytarabine Small molecule Intrathecal
Background Methotrexate Small molecule Intrathecal
Background Pegfilgrastim Protein / enzyme biologic Subcutaneous
Background Rituximab Monoclonal antibody Intravenous
Background Vincristine Small molecule Intravenous
Background filgrastim Protein / enzyme biologic Subcutaneous