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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07153796
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