RecruitingPhase 2NCT03263572

Blinatumomab, Methotrexate, Cytarabine, and Ponatinib in Treating Patients With Philadelphia Chromosome-Positive, or BCR-ABL Positive, or Relapsed/Refractory, Acute Lymphoblastic Leukemia

Phase II Study of the Combination of Blinatumomab and Ponatinib in Patients With Philadelphia Chromosome (Ph)-Positive and/or BCR-ABL Positive Acute Lymphoblastic Leukemia (ALL)


Sponsor

M.D. Anderson Cancer Center

Enrollment

90 participants

Start Date

Nov 29, 2017

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trial studies how well blinatumomab, methotrexate, cytarabine, and ponatinib work in treating patients with Philadelphia chromosome (Ph)-positive, or BCR-ABL positive, or acute lymphoblastic leukemia that has come back or does not respond to treatment. Immunotherapy with monoclonal antibodies, such as blinatumomab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as 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. Ponatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving blinatumomab, methotrexate, cytarabine, and ponatinib may work better in treating patients with acute lymphoblastic leukemia.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of four drugs — blinatumomab, methotrexate, cytarabine, and ponatinib — to treat a form of acute lymphoblastic leukemia (blood cancer) that is linked to a specific genetic change called the Philadelphia chromosome (BCR-ABL), including newly diagnosed patients and those whose cancer has returned or stopped responding to treatment. **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of Philadelphia chromosome-positive (BCR-ABL+) ALL, or with leukemia that has relapsed or become resistant to previous treatment - You are in reasonably good physical condition (ECOG 0–2) - Your liver, kidney, and heart function meet the required levels **You may NOT be eligible if...** - You have a history of pancreatitis or alcohol abuse - You have uncontrolled high blood pressure, recent heart attack or stroke, or severe heart failure - You have active HIV, hepatitis B, or hepatitis C - You have had a significant seizure disorder or serious brain condition (not including active brain leukemia, which is allowed) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALBlinatumomab

Given IV

DRUGCytarabine

Given intrathecally via spinal tap

DRUGMethotrexate

Given intrathecally via spinal tap

DRUGPonatinib

Given PO


Locations(1)

M D Anderson Cancer Center

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT03263572


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