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Tyrosine Kinase Inhibitor
Blinatumomab + Asciminib for Acute Lymphoblastic Leukemia
Phase 2
Waitlist Available
Led By Nicholas Short, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; an average of 1 year.
Awards & highlights
Study Summary
"This trial is looking to see if using both blinatumomab and asciminib together can help manage Ph+ ALL."
Who is the study for?
This trial is for patients with a type of leukemia known as Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ ALL). Specific eligibility criteria are not provided, but typically participants would need to meet certain health standards and may be required to have tried other treatments first.Check my eligibility
What is being tested?
The study is testing the effectiveness of combining two drugs, Blinatumomab and Asciminib, in treating Ph+ ALL. It's a Phase II trial, which means it focuses on the treatment's efficacy and side effects in a larger group than initial trials.See study design
What are the potential side effects?
While specific side effects are not listed here, common ones for cancer treatments like Blinatumomab and Asciminib can include fatigue, fever, bleeding or bruising easily due to low blood cell counts, nausea or vomiting.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion; an average of 1 year.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; an average of 1 year.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety and adverse events (AEs)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Blinatumomab + AsciminibExperimental Treatment2 Interventions
Participants found to be eligible to take part in this study will receive 5 cycles of blinatumomab and asciminib, followed by asciminib alone for as long as it benefits the participant.
Participants will receive blinatumomab as a continuous (non-stop) infusion on Days 4-31 of Cycle 1 and on Days 1-28 of Cycles 2-5.
Participants will take asciminib by mouth 2 times every day during this study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Blinatumomab
2014
Completed Phase 3
~1210
Asciminib
2018
Completed Phase 1
~570
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,967 Previous Clinical Trials
1,804,762 Total Patients Enrolled
Novartis PharmaceuticalsIndustry Sponsor
2,855 Previous Clinical Trials
4,197,313 Total Patients Enrolled
Nicholas Short, MDPrincipal InvestigatorM.D. Anderson Cancer Center
5 Previous Clinical Trials
324 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any available openings for patients to participate in this study?
"As per information on clinicaltrials.gov, recruitment for this medical trial has ceased. The study was first listed on September 30th, 2024, and last updated on March 7th, 2024. Although this particular trial is no longer enrolling participants, there are currently 1494 other trials actively seeking patients."
Answered by AI
Has the combination of Blinatumomab and Asciminib received approval from the FDA?
"Based on our assessment at Power, the safety rating for Blinatumomab + Asciminib is marked as 2. This designation aligns with it being a Phase 2 trial where there are indications of safety but no evidence supporting efficacy yet."
Answered by AI
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