RecruitingPhase 2NCT02997761

Ibrutinib and Blinatumomab in Treating Patients With Relapsed or Refractory B Acute Lymphoblastic Leukemia

A Phase 2 Study of Ibrutinib and Blinatumomab in Relapsed and Refractory B-Cell Acute Lymphoblastic Leukemia


Sponsor

Brian Jonas

Enrollment

20 participants

Start Date

Jun 27, 2017

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trial studies how well ibrutinib and blinatumomab work in treating patients with B acute lymphoblastic leukemia that has come back or is not responding to treatment. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as blinatumomab, may interfere with the ability of cancer cells to grow and spread. Giving ibrutinib and blinatumomab may work better in treating patients with relapsed or refractory B acute lymphoblastic leukemia.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two targeted drugs — ibrutinib and blinatumomab — in patients with a type of blood cancer called B-cell acute lymphoblastic leukemia (B-ALL) that has come back or stopped responding to previous treatments. **You may be eligible if...** - You have been confirmed to have relapsed or refractory B-cell ALL (a cancer of immature white blood cells that has returned or is resistant to treatment) - Your cancer has measurable disease visible on bone marrow testing or imaging (CT/PET scan) - If your cancer has a gene change called Philadelphia chromosome (Ph+), you must have tried at least one second-generation targeted therapy and it must have failed - You have had a prior stem cell transplant (this is allowed) - Your organ function meets the minimum required levels **You may NOT be eligible if...** - You have active central nervous system (brain/spinal cord) involvement that is untreated - You have uncontrolled serious infections - You are pregnant or breastfeeding - You are taking certain blood-thinning or interacting medications that cannot be stopped 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

DRUGIbrutinib

Given PO


Locations(1)

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

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NCT02997761


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