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Active Not Recruiting
NCT07153796
A Phase 1b/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
Conditions: B-cell Acute Lymphoblastic Leukemia
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1, PHASE2
Enrollment: 3
Sponsor: M.D. Anderson Cancer Center
Location: The University of Texas M. D. Anderson Cancer Center Houston Texas
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 Criteria
Inclusion Criteria:
* Patients 60 years or older with previously untreated Ph-negative B-ALL. Patients may have received minimal prior therapy before (up to 2 cycles of previous therapy)
* Patients 18 to 59 years of age with previously untreated Ph-negative B-ALL who are deemed medically unfit for intensive chemotherapy. Patients may have received minimal prior therapy (up to 2 cycles of previous therapy)
* Unfit patients are defined as having at least one of the below comorbidities:
1. COG \>2
2. Severe cardiac disorder (e.g., congestive heart failure requiring treatment, ejection fraction \
Source: ClinicalTrials.gov (NCT07153796). StuddyBuddy aggregates publicly available trial information.
