RecruitingPhase 1Phase 2NCT06287229

Phase Ib/II Study Assessing the Clinical Activity and Safety of Brexucabtagene Autoleucel as a Consolidation in Patients With Relapsed/Refractory (R/R) and Newly Diagnosed B-cell Acute Lymphocytic Leukemia (ALL) Post Cytoreduction With Mini-HCVD-inotuzumab-blinatumomab/HCVAD-inotuzumab-blinatumomab


Sponsor

M.D. Anderson Cancer Center

Enrollment

40 participants

Start Date

Jul 11, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

To learn about the safety of giving the drug brexucabtagene autoleucel to participants with relapsed/refractory B-cell ALL after treatment with inotuzumab ozogamicin, blinatumomab, and either hyper-CVAD or mini-hyper-CVD. Also, to learn if giving brexucabtagene autoleucel to patients with relapsed/refractory or high-risk, newly diagnosed B-cell ALL after treatment with inotuzumab ozogamicin, blinatumomab, and either hyper-CVAD or mini-hyper-CVD can help to control the disease.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a CAR-T cell therapy called brexucabtagene autoleucel as a consolidation treatment for adults with B-cell acute lymphoblastic leukemia (ALL) — a blood cancer — after initial chemotherapy has reduced the disease. **You may be eligible if...** - You are 18 or older with relapsed or refractory B-cell ALL - OR you have newly diagnosed high-risk B-cell ALL with specific genetic features - Your leukemia cells express the CD19 marker (more than 50% positive) - Your organ function (kidneys, liver, bilirubin) is within acceptable limits **You may NOT be eligible if...** - Your leukemia cells do not express CD19 - You have uncontrolled viral infections (e.g., Hepatitis B or C, HIV) - Your organ function is too poor to tolerate this therapy - You have had a prior CAR-T cell treatment targeting CD19 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

DRUGBlinatumomab

Given by Infusion

DRUGInotuzumab Ozogamicin

Given by IV

DRUGHyper-CVAD

Given by IV Participants younger than 60 years of age, you will receive hyper-CVAD.

DRUGMini-hyper-CVD

Given by IV Participants 60 years of age or older, you will receive mini-hyper-CVD


Locations(1)

MD Anderson Cancer Center

Houston, Texas, United States

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NCT06287229


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