Actively Recruiting
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
Led by M.D. Anderson Cancer Center · Updated on 2026-05-05
60
Participants Needed
1
Research Sites
400 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
A
Amgen
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 60 years or older with previously untreated Ph-negative B-ALL, allowing up to 2 prior therapy cycles
- Patients aged 18 to 59 with previously untreated Ph-negative B-ALL deemed medically unfit for intensive chemotherapy, allowing up to 2 prior therapy cycles
- Unfit patients defined by at least one: COG >2, severe cardiac disorder, severe pulmonary disorder, or hepatic disorder with bilirubin 1.5 times upper limit
- ECOG performance status of 0, 1, or 2
- Adequate organ function with creatinine clearance >50 mg/min/1.73m2, bilirubin ≤3.5 mg, ALT/AST ≤5 times upper limit
- Agreement to use adequate contraception for women of childbearing potential and men, including specific methods and abstinence, during study and follow-up
- Ability to understand and sign informed consent
You will not qualify if you...
- Pregnant or breastfeeding women
- Women of childbearing potential without negative pregnancy test
- Female participants unwilling or unable to use effective contraception during treatment and 4 months after last dose
- Prior therapy with subcutaneous Blinatumomab
- Philadelphia chromosome-positive B-ALL
- Known HIV-positive status
- Active inflammatory or infectious hepatitis, or chronic hepatitis with detectable viral load without suppression
- Active and uncontrolled infections or diseases
- Cardiac ejection fraction <40%
- Inability or unwillingness to sign informed consent
- Use of other investigational therapy within past 14 days
- Symptomatic central nervous system disease at enrollment
- History or presence of significant CNS disorders or severe CNS events
- Concurrent anti-leukemia therapy except specific tyrosine kinase inhibitors for Ph-like ALL
- Current uncontrolled autoimmune disease or history with CNS involvement
- Psychiatric or social conditions limiting study compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
E
Elias Jabbour, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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