Blinatumomab + Olverembatinib for Acute Lymphoblastic Leukemia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines whether two treatments, blinatumomab (a type of immunotherapy) and olverembatinib (a new potential drug), can help control acute lymphoblastic leukemia (ALL) that is Philadelphia chromosome-positive (Ph-positive) or BCR::ABL1-positive. The study evaluates the effectiveness of these treatments when combined to address this specific type of leukemia. Eligible participants may include individuals with Ph-positive ALL or chronic myeloid leukemia (CML) in a certain aggressive phase, who have already undergone some chemotherapy. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.
Do I have to stop taking my current medications to join the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss your specific medications with the trial team to get a clear answer.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the combination of blinatumomab and olverembatinib is promising in terms of safety. Studies have found that this combination works well and is generally easy for patients to handle, with most experiencing no severe side effects.
One study indicated that using these treatments without chemotherapy has been safe for patients. Olverembatinib alone has been linked to high rates of complete remission, where no cancer cells are found, which is a positive sign for its safety.
While the treatment is still being tested, current data suggest it is generally safe for people. However, as with any treatment, individual reactions can vary, so discussing any concerns with a healthcare provider is important.12345Why are researchers excited about this trial's treatments?
Most treatments for acute lymphoblastic leukemia (ALL) involve chemotherapy and targeted therapies like tyrosine kinase inhibitors. However, Blinatumomab and Olverembatinib offer something different. Researchers are excited because Blinatumomab is a bispecific T-cell engager that directs the body's immune cells to attack leukemia cells, providing a unique mechanism compared to traditional chemotherapy. Meanwhile, Olverembatinib is a potent second-generation tyrosine kinase inhibitor that targets specific mutations more effectively than earlier drugs. Together, these treatments promise a more targeted and potentially less toxic approach to battling ALL.
What evidence suggests that this trial's treatments could be effective for acute lymphoblastic leukemia?
Research has shown that the combination of blinatumomab and olverembatinib, which participants in this trial will receive, may effectively treat Ph-positive acute lymphoblastic leukemia (ALL), a type of blood cancer. In earlier studies, all patients achieved complete remission after the initial treatment, with no signs of cancer detected. After one treatment cycle, 72.7% of patients had no detectable cancer at the molecular level, increasing to 90.1% after two cycles. Another study found that 88.2% of patients were still alive after two years, and 62.9% had not experienced a recurrence of the cancer. These findings suggest that this treatment could be a strong option for controlling the disease.12367
Who Is on the Research Team?
Elias J Jabbour, MD
Principal Investigator
M.D. Anderson Cancer Center
Are You a Good Fit for This Trial?
This trial is for patients with Ph-positive and/or BCR::ABL1-positive ALL or certain phases of CML. They must have good liver, cardiac, and pancreatic function, be able to perform daily activities (ECOG ≤2), not be pregnant, agree to use contraception, and sign consent. Excluded are those with serious infections, other cancers except skin cancer, severe heart issues or recent heart events, uncontrolled blood pressure or bleeding disorders.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive subcutaneous blinatumomab and oral olverembatinib
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Blinatumomab
- Olverembatinib
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
Amgen
Industry 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
Ascentage Pharma Group Inc.
Industry Sponsor