Immunotherapy for Infant Leukemia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a treatment called blinatumomab, a type of immunotherapy, to determine if it can clear leukemia in infants. Blinatumomab targets a molecule called CD19 found on leukemia cells. The trial aims to improve upon previous treatments for persistent leukemia. Infants diagnosed with CD19 positive acute lymphoblastic leukemia (ALL) or a similar type of leukemia, who have had only limited prior treatment, might be a good fit for this study. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but it does mention that only limited prior therapy is allowed. It's best to discuss your current medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that blinatumomab is generally safe for children with leukemia. Studies found that serious side effects occurred in about 28% of patients, but no deaths were linked to the treatment. A review of multiple studies also found that blinatumomab has fewer severe side effects compared to other treatments. Overall, the safety profile of blinatumomab aligns with existing knowledge, suggesting it is usually well-tolerated.12345
Why are researchers excited about this possible treatment for leukemia?
Blinatumomab is unique because it leverages a novel mechanism called bispecific T-cell engager (BiTE) technology to treat infant leukemia. Unlike standard treatments that typically involve chemotherapy, Blinatumomab connects T-cells directly to cancer cells, prompting the immune system to attack the leukemia more efficiently. Researchers are excited about this treatment as it represents a more targeted approach, potentially leading to fewer side effects and improved outcomes for young patients.
What evidence suggests that blinatumomab might be an effective treatment for infant leukemia?
Research has shown that blinatumomab, which participants in this trial will receive, can help treat certain types of childhood leukemia. Studies have found that it improves outcomes for children with relapsed B-cell acute lymphoblastic leukemia (ALL). Specifically, one study found that 39% of patients went into complete remission, with no cancer cells detected in their blood. Additionally, using blinatumomab with standard chemotherapy improved the chances of staying disease-free. These findings suggest that blinatumomab could be a promising option for targeting leukemia cells.13678
Who Is on the Research Team?
Tanja A Gruber, MD, PhD
Principal Investigator
Stanford University
Are You a Good Fit for This Trial?
This trial is for infants up to 1 year old with a new diagnosis of CD19 positive acute lymphoblastic leukemia or related conditions, with limited prior treatment. They must have more than 25% leukemia cells in their bone marrow and can have some previous short-term treatments like hydroxyurea or glucocorticoids.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Remission Induction
Participants receive initial treatment to induce remission using a combination of chemotherapy and immunotherapy
Induction Intensification
Participants undergo intensified treatment to clear persistent leukemia, including the use of blinatumomab
Consolidation I
Participants receive treatment to consolidate remission and prevent relapse
Reinduction Block I
Participants undergo reinduction therapy to further reduce leukemia cells
Reinduction Block II
Participants undergo a second reinduction therapy to ensure minimal residual disease
Consolidation II
Participants receive additional consolidation therapy to maintain remission
Maintenance
Participants receive maintenance therapy to prevent relapse over a long-term period
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Blinatumomab
Find a Clinic Near You
Who Is Running the Clinical Trial?
Tanja Andrea Gruber
Lead Sponsor
Stanford University
Lead Sponsor
Lucile Packard Children's Hospital Foundation
Collaborator
Kura Oncology
Collaborator
United States Department of Defense
Collaborator
Cannonball Kid's Cancer
Collaborator
Kura Oncology, Inc.
Industry 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
Pediatric Oncology Experimental Therapeutics Investigators' Consortium
Collaborator
Lucile Packard Foundation for Children's Health
Collaborator