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
M.D. Anderson Cancer Center
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.
Description
Primary Objective: a) To evaluate event-free survival (EFS, time from treatment initiation to relapse or death) of SC Blinatumomab in combination with low-intensity chemotherapy in older and unfit patients with newly diagnosed Ph-negative B-cell ALL Secondary Objectives: 1. Determine efficacy of SC Blinatumomab in combination with low-intensity chemotherapy in older and unfit patients with newly diagnosed Ph-negative B-cell ALL through the overall response rate (complete remission \[CR\] + complete remission with incomplete count recovery \[CRi\]) 2. Determine overall survival (OS, time fro…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 fract…
Interventions
- DrugBlinatumomab
Given by IV
- DrugMini-CVD
Given by IV
- DrugMTX/ARA-C
Given by IV
Location
- The University of Texas M. D. Anderson Cancer CenterHouston, Texas