A Phase 1/2 Study of Concurrent Inotuzumab and Subcutaneous Blinatumomab in Adult Patients With B-cell Acute Lymphoblastic Leukemia
Memorial Sloan Kettering Cancer Center
Summary
The purpose of this study is to find out whether combining inotuzumab and blinatumomab is a safe and effective treatment for participants with newly diagnosed B-cell acute lymphoblastic leukemia (B-ALL).
Eligibility
- Age range
- 18–55 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age ≥ 18 years of age. * Newly diagnosed CD19+ and CD22+ B-ALL with the following characteristics * Patients ≥55 years old, OR * Patients 18-54 years old who decline or are deemed unfit for conventional chemotherapy with at least one of the following criteria: * ECOG performance status of 2 or more * Severe cardiac comorbidity (including congestive heart failure requiring treatment) * Known pulmonary comorbidity (including DLCO ≤65% or FEV1 ≤65%) * Renal comorbidity (including creatinine clearance 30-45 mL/min) * Relapsed or refractory CD19+ and CD22+ B-ALL * Patien…
Interventions
- DrugBlinatumomab Injection
Blinatumomab given via subcutaneous injection
Location
- Memorial Sloan Kettering Cancer Center (All Protocol Activities)New York, New York