RecruitingPhase 2NCT06686108

Demethylating Agents Combined With Venetoclax for High-risk T-cell Lymphoblastic Lymphoma/Leukemia Post-Transplant Relapse Prevention

Safety and Efficacy Study of Demethylating Agents With Venetoclax in Preventing Recurrence of High-risk T-cell Lymphoblastic Lymphoma/Leukemia After Transplantation


Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Enrollment

59 participants

Start Date

Oct 30, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a prospective, phase II clinical trial with the primary objective of assessing the effectiveness of demethylating agents combined with venetoclax in the prevention of recurrence after allogeneic hematopoietic stem cell transplantation (allo-HSCT) of high risk T-lymphoblastic lymphoma/leukemia (T-LBL/ALL) patients.


Eligibility

Min Age: 14 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether giving a combination of DNA-demethylating drugs plus venetoclax (a targeted cancer drug) after a bone marrow transplant can prevent relapse in people who were treated for high-risk T-cell lymphoma or leukemia (T-LBL/ALL). **You may be eligible if...** - You are 14–55 years old - You have undergone an allogeneic bone marrow/stem cell transplant for T-cell lymphoblastic lymphoma or leukemia - You have at least one high-risk feature (such as older age at diagnosis, high white blood cell count, or specific genetic mutations) - Your blood counts are in the required range - You are in remission (no signs of disease returning) **You may NOT be eligible if...** - Your cancer came back before or was never in complete remission before the transplant - You are allergic to venetoclax or demethylating drugs - You have active graft-versus-host disease (a complication after transplants) at grade 2 or higher - You have poor organ function (kidneys, liver) - You are pregnant or breastfeeding 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

DRUGAzacitidine (AZA) Days 1 - 5

Azacitidine, ih, 32mg/m2/d, days 1-5 of each 28-day cycle

DRUGDecitabine (DAC)

decitabine, 5mg/m2/d, days 1-5 of each 28-day cycle.

DRUGVenetoclax

venetoclax, 400mg/d, days 1-7 of each 28-day cycle


Locations(1)

Shanghai General Hospital

Shanghai, China

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NCT06686108


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