Phase 2 Study on Calaspargase Pegol-mknl, Decitabine, and Venetoclax for Treating Relapsed or Hard-to-Treat T-Cell Leukemia and Lymphoma in Young Patients
Sponsor: M.D. Anderson Cancer Center
ClinicalTrials ID:NCT06561074
This clinical trial is testing a combination of three drugs—calaspargase pegol-mknl, decitabine, and venetoclax—to see if they can help control T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LLy) in children, teens, and young adults whose cancer has returned or is not responding to treatment.
Patient Parameters
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Program Overview
The study aims to find out if the combination of calaspargase pegol-mknl, decitabine, and venetoclax can effectively treat relapsed or refractory T-ALL and T-LLy in young patients. Researchers will also study the safety of this drug combination and how well it works in terms of complete response rates, survival, and the ability to proceed to stem cell transplant. The study will also look at how the drugs are processed in the body and their effects on the disease.
Description
This study is focused on evaluating the effectiveness and safety of a drug combination for young patients with T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LLy) that has come back or is not responding to treatment. The main goal is to see how well the drugs work together to achieve a complete response, which means no signs of cancer. Researchers will also look at overall survival, event-free survival, and the rate of minimal residual disease negativity, which indicates how much cancer is left after treatment.
The study will also monitor any side effects and how severe they are, as well as how the treatment affects the possibility of moving on to a stem cell transplant. Additionally, the study will explore how the drugs are absorbed and processed in the body and their impact on treatment outcomes.
Participants will be children, teens, and young adults who meet specific health criteria. The study will involve taking the study drugs and undergoing regular health checks to monitor progress and any side effects.
Eligibility Criteria
Inclusion Criteria
- Children, teens, or young adults with relapsed or hard-to-treat T-cell leukemia or lymphoma.
- Must be between 1 month and 21 years old.
- Must be in good general health, with specific performance scores based on age.
- Can have asymptomatic central nervous system (CNS) disease.
- Must have good organ function and specific lab results within normal ranges.
- Females of childbearing age must have a negative pregnancy test and agree to use effective birth control during the study and for 3 months after.
- Males must agree to use condoms and not donate sperm during the study and for 90 days after.
- Must be able to swallow tablets or use oral dispersible tablets.
- Must have had at least 30 days since any previous stem cell transplant.
Exclusion Criteria
- History of other cancers, except for certain non-threatening types.
- Uncontrolled CNS conditions like epilepsy or severe brain injuries.
- Recent major surgery or significant injury.
- Uncontrolled infections or serious heart conditions.
- Pregnant or breastfeeding women, or those planning to become pregnant soon.
- Currently in another clinical trial with investigational products.
- Severe liver disease or alcohol abuse.
- Unable to comply with study requirements.
- History of severe allergic reactions to similar treatments.
- Blood clotting disorders or recent thromboembolic events.
- Recent use of certain medications or foods that interact with the study drugs.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| MD Anderson Cancer Center | 77090 | Houston | Texas |
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