Blinatumomab for Acute Lymphoblastic Leukemia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called blinatumomab for children under 12 with acute lymphoblastic leukemia (ALL). Researchers aim to determine if this treatment is safe and effective when administered as a shot under the skin. The trial targets children whose cancer has returned, hasn't responded to other treatments, or who have residual cancer cells after treatment. Children with frequent relapses or non-responsive cancer might be suitable for this trial. As a Phase 1/Phase 2 trial, the study seeks to understand how the treatment works and measure its effectiveness in a smaller group, offering early access to a potentially beneficial therapy.
Will I have to stop taking my current medications?
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.
Is there any evidence suggesting that blinatumomab is likely to be safe for children?
Research has shown that blinatumomab is generally safe and effective for treating acute lymphoblastic leukemia (ALL). Studies in both adults and children indicate it is well-tolerated. Some side effects, such as cytokine release syndrome (an immune system overreaction) and neurological symptoms (issues related to the brain or nerves), have been reported. However, these side effects are usually manageable. A meta-analysis, which combined results from several studies, focused on safety in children and confirmed that blinatumomab's safety is acceptable. Additionally, the FDA has approved blinatumomab for treating this type of leukemia in both adults and children, indicating it has met strict safety standards.12345
Why do researchers think this study treatment might be promising for leukemia?
Most treatments for acute lymphoblastic leukemia (ALL) involve chemotherapy or targeted therapies like tyrosine kinase inhibitors. However, blinatumomab is unique because it uses a bispecific T-cell engager (BiTE) technology, which links cancer cells to T-cells, directly engaging the immune system to attack the leukemia cells. Unlike traditional chemotherapy, which can have widespread effects on the body, blinatumomab is designed to specifically target and destroy cancerous cells. Researchers are excited about this treatment due to its potential to offer a more precise and less toxic option for patients, especially those with relapsed or refractory B-ALL.
What evidence suggests that blinatumomab might be an effective treatment for acute lymphoblastic leukemia?
Research has shown that blinatumomab effectively treats acute lymphoblastic leukemia (ALL), particularly in children. One study found that children receiving blinatumomab with chemotherapy had an 80% chance of remaining cancer-free for three years, compared to 64% for those not receiving blinatumomab. Another study demonstrated that blinatumomab outperformed traditional chemotherapy alone, with a 63% chance of staying cancer-free compared to 31.4%. In this trial, participants with relapsed or refractory B-cell ALL will receive blinatumomab to assess its effectiveness. Blinatumomab aids the immune system in identifying and destroying cancer cells, offering hope for those facing relapsed or difficult-to-treat B-cell ALL.6789
Who Is on the Research Team?
MD
Principal Investigator
Amgen
Are You a Good Fit for This Trial?
This trial is for children under 12 with B-cell precursor acute lymphoblastic leukemia (B-ALL) that has come back or hasn't responded to treatment, including stem cell transplant. They must have a certain level of activity and enough cancer cells in their bone marrow to qualify. Kids who've had CD19-directed therapy can join if it's been over 4 weeks without brain complications.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase 1b Treatment
Participants with R/R B-ALL receive blinatumomab as SC injection to determine the pediatric recommended Phase 2 dose
Phase 2 Treatment
Participants with R/R and MRD+ B-ALL receive blinatumomab as SC injection at RP2D
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Blinatumomab
Trial Overview
The study tests Blinatumomab given under the skin (subcutaneously) to see how safe and effective it is for these young patients. It aims to find out if this approach could help manage leukemia by targeting specific cancer cells without causing too much harm.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Participants with R/R B-ALL will receive blinatumomab as SC injection to determine the pediatric recommended Phase 2 dose (RP2D).
Participants with R/R B-ALL will receive blinatumomab as SC injection at RP2D.
Participants with MRD+ B-ALL will receive blinatumomab as SC injection at RP2D.
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
BeOne Medicines
Industry Sponsor
Citations
Efficacy of Blinatumomab in Pediatric Acute Lymphoblastic ...
The three-year relapse-free survival rate was 80% for the group receiving both blinatumomab and chemotherapy, compared to 64% for those ...
2.
ashpublications.org
ashpublications.org/blood/article/142/Supplement%201/5906/506260/A-Real-World-Evidence-on-Effectiveness-and-SafetyA Real-World Evidence on Effectiveness and Safety of ...
This study showed that using blinatumomab for remission induction and consolidation with one to five cycles was effective in the treatment of patients with B- ...
3.
stjude.org
stjude.org/research/progress/2024/blinatumomab-added-to-chemo-improves-survival-for-adults-with-all.htmlBlinatumomab added to chemotherapy improves survival ...
B-cell precursor acute lymphoblastic leukemia (B-ALL) has a cure rate exceeding 85% in children, but outcomes in adults are poor.
Blinatumomab consolidation in children with high-risk first ...
Blinatumomab was more effective than conventional chemotherapy in achieving higher relapse-free survival probability (63% vs 31.4%, p < 0.001) ( ...
Safety and efficacy of blinatumomab: a real world data
Treatment with blinatumomab is effective and tolerable in adult patients with relapsed/refractory B-ALL outside of a clinical trial stetting.
Safety and Efficacy of Blinatumomab- Real World Data
Safety data including cytokine release and neurological symptoms was collected. Efficacy outcome included overall and complete response rates, overall survival, ...
7.
ashpublications.org
ashpublications.org/blood/article/146/Supplement%201/6860/554360/Efficacy-and-safety-of-blinatumomab-as-frontlineEfficacy and safety of blinatumomab as frontline treatment for ...
Multiple center studies have demonstrated the favorable efficacy of blinatumomab in adult and pediatric ALL. We report the efficacy and safety ...
The safety of blinatumomab in pediatric patients with acute ...
The present meta-analysis aimed to assess the safety profile of blinatumomab in terms of serious adverse events, CRS, and neurologic events.
Pediatric & AYA 20120215 Study
BLINCYTO ® (blinatumomab) is indicated for the treatment of CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adult and pediatric patients ...
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