Blinatumomab and Chemotherapy for Acute Lymphoblastic Leukemia
Trial Summary
What is the purpose of this trial?
The safety run-in part of the study aims to evaluate the safety and tolerability of blinatumomab alternating with low-intensity chemotherapy. The phase 3 part of the study aims to compare event-free survival (EFS) and overall survival (OS) of participants receiving blinatumomab alternating with low-intensity chemotherapy to EFS and (OS) of participants receiving standard of care (SOC) chemotherapy.
Do I need to stop my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
What data supports the effectiveness of the drug Blinatumomab for treating acute lymphoblastic leukemia?
Blinatumomab has been shown to improve survival and remission rates in patients with relapsed or refractory acute lymphoblastic leukemia (ALL). In a study, patients receiving Blinatumomab had a higher complete remission rate (34%) compared to those receiving standard chemotherapy (16%), and a longer median survival time (7.7 months vs. 4.0 months).12345
Is Blinatumomab safe for humans?
Blinatumomab has been used in clinical trials for acute lymphoblastic leukemia and is generally considered safe, but it can cause side effects like cytokine release syndrome (a severe immune reaction) and neurological issues such as tremors and depression. It has a favorable safety profile compared to standard chemotherapy, with less risk of severe blood-related side effects.12367
How is the drug Blinatumomab different from other treatments for acute lymphoblastic leukemia?
Research Team
MD
Principal Investigator
Amgen
Eligibility Criteria
Adults aged 55+ with newly diagnosed Philadelphia-negative B-cell precursor acute lymphoblastic leukemia (ALL) can join. Those 40-54 with severe comorbidities may also qualify. Participants need an ECOG performance status ≤2, adequate kidney and liver function, and a heart ejection fraction ≥50%. Exclusions include active CNS leukemia, autoimmune diseases affecting the CNS, HIV/Hepatitis B or C infections, uncontrolled chronic infections, or prior cancer chemotherapy for ALL.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Safety Run-in
Evaluate the safety and tolerability of blinatumomab alternating with low-intensity chemotherapy
Phase 3 Treatment
Participants receive blinatumomab alternating with low-intensity chemotherapy or standard of care chemotherapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Blinatumomab
- Low-intensity chemotherapy regimen
- SOC chemotherapy regimen
Blinatumomab is already approved in European Union, United States for the following indications:
- Relapsed or refractory B-cell precursor acute lymphoblastic leukemia (BCP-ALL)
- High-risk first relapse BCP-ALL
- Relapsed or refractory B-cell precursor acute lymphoblastic leukemia (BCP-ALL)
- First or second complete remission with minimal residual disease (MRD)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Amgen
Lead Sponsor
Robert A. Bradway
Amgen
Chief Executive Officer since 2012
MBA from Harvard Business School
Paul Burton
Amgen
Chief Medical Officer since 2023
MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London