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ACTIVE NOT RECRUITING
NCT03147612
PHASE2

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

Sponsor: M.D. Anderson Cancer Center

View on ClinicalTrials.gov

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.

Official title: Phase II Study of the Sequential Combination of Low-Intensity Chemotherapy and Ponatinib Followed by Blinatumomab and Ponatinib in Patients With Philadelphia Chromosome (Ph)-Positive and/or BCR-ABL Positive Acute Lymphoblastic Leukemia (ALL)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

22

Start Date

2018-02-08

Completion Date

2027-02-28

Last Updated

2026-02-17

Healthy Volunteers

No

Interventions

BIOLOGICAL

Blinatumomab

Given via central catheter

DRUG

Cyclophosphamide

Given IV

DRUG

Cytarabine

Given intrathecally or IV

BIOLOGICAL

Filgrastim

Given SC

DRUG

Methotrexate

Given intrathecally or IV

BIOLOGICAL

Pegfilgrastim

Given SC

DRUG

Ponatinib

Given PO

BIOLOGICAL

Rituximab

Given IV

DRUG

Vincristine

Given IV

Locations (1)

M D Anderson Cancer Center

Houston, Texas, United States