RecruitingPhase 2NCT07153796

A Phase 2 Study to Assess the Safety and Efficacy of Subcutaneous Blinatumomab in Combination With Low Intensity Chemotherapy in Older Patients With Newly Diagnosed B-cell Acute Lymphoblastic Leukemia


Sponsor

M.D. Anderson Cancer Center

Enrollment

60 participants

Start Date

Jan 30, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This is a single arm open-label phase 2 trial to study the safety and efficacy of SC Blinatumomab in combination with low-intensity chemotherapy for older or unfit patients with B-ALL.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Phase 2 study is testing a combination of subcutaneous blinatumomab (an injectable immunotherapy) with low-intensity chemotherapy in older adults or medically unfit patients newly diagnosed with a type of leukemia called B-cell acute lymphoblastic leukemia (B-ALL) that does not have the Philadelphia chromosome. **You may be eligible if...** - You are 60 or older with newly diagnosed Ph-negative B-ALL, OR - You are between 18 and 59 with Ph-negative B-ALL but are not fit for intensive chemotherapy due to a significant health condition (e.g., heart or lung problems) - You have adequate organ function (kidney, liver) - You are willing to use contraception during and after treatment **You may NOT be eligible if...** - You are pregnant or breastfeeding - You are HIV-positive - You have active, untreated hepatitis B or C - You have Philadelphia chromosome-positive leukemia - You have a serious neurological or psychiatric condition (including prior severe reactions from CAR-T therapy) - You have had previous treatment with blinatumomab - You have active autoimmune disease - Your heart pumping function is below 40% 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 IV

DRUGMini-CVD

Given by IV

DRUGMTX/ARA-C

Given by IV


Locations(1)

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, United States

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NCT07153796


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