RecruitingPhase 2NCT06561074
A Phase 2 Study to Evaluate Efficacy of Calaspargase Pegol-mknl and Decitabine Combined With Venetoclax in Pediatric, Adolescent, and Young Adult Patients With Relapsed/Refractory T-cell Acute Lymphoblastic Leukemia (T-ALL) and T- Cell Lymphoblastic Lymphoma (T-LLy)
Sponsor
M.D. Anderson Cancer Center
Enrollment
22 participants
Start Date
Sep 25, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
To learn if giving the study drugs calaspargase pegol-mknl and decitabine in combination with venetoclax can help to control relapsed/refractory T-ALL and T-LLy. The safety of this drug combination will also be studied.
Eligibility
Min Age: 1 MonthMax Age: 21 Years
Plain Language Summary
Simplified for easier understanding
This study tests a combination of three drugs — calaspargase, decitabine, and venetoclax — for children, teenagers, and young adults (up to age 21) with T-cell leukemia or T-cell lymphoblastic lymphoma that has returned or stopped responding to treatment.
**You may be eligible if...**
- You are aged 1 month to 21 years with relapsed or treatment-resistant T-cell leukemia or T-cell lymphoblastic lymphoma
- You have adequate organ function and can swallow tablets
- You are at least 30 days past a prior stem cell transplant
**You may NOT be eligible if...**
- You have another active cancer
- You have severe uncontrolled infections or serious heart disease
- You have a history of severe allergic reaction to asparaginase
- You have a history of pancreatitis (grade 3 or severe anaphylaxis from asparaginase)
- You are pregnant or planning to become pregnant
Talk to your doctor to see if this trial is right for you.
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
DRUGDecitabine
Given by vein
DRUGVenetoclax
Given by mouth
DRUGCalaspargase pegol-mknl
Given by vein
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06561074
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