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)

MD Anderson Cancer Center

Houston, Texas, United States

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NCT06561074


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