RecruitingPhase 2NCT06393985

Decitabine, Venetoclax and Blinatumomab for Maintenance Following HSCT in Patients With Ph-Negative B-ALL

A Multicenter, Prospective, Phase II Study of Decitabine, Venetoclax and Blinatumomab for Maintenance Following Allogeneic Hematopoietic Cell Transplantation in Patients With Ph-Negative B-Cell Acute Lymphoblastic Leukemia


Sponsor

The First Affiliated Hospital of Soochow University

Enrollment

30 participants

Start Date

Apr 25, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study aims to evaluate whether maintenance therapy with decitabine, venetoclax and blinatumomab could improve the 2-year progression free survival (PFS) of patients with philadelphia chromosome-negative B-cell acute lymphoblastic leukemia who had recently received an allogeneic stem cell transplant and in measurable residual disease-negative remission.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a maintenance therapy regimen — combining decitabine, venetoclax, and blinatumomab (three cancer drugs) — to prevent relapse after a stem cell transplant in people with Philadelphia chromosome-negative B-cell acute lymphoblastic leukemia (B-ALL), a type of blood cancer. **You may be eligible if...** - You have Ph-negative B-cell ALL and have undergone an allogeneic stem cell transplant (using a donor's cells) - You are at least 3 months post-transplant with your blood counts recovering - You have no detectable leukemia remaining (confirmed by sensitive blood tests) - You had high-risk features at diagnosis, did not achieve remission after initial chemotherapy, had detectable disease before transplant, or were in second or later remission - Your liver, kidney, and heart function are within acceptable limits **You may NOT be eligible if...** - You have another active cancer - You have an uncontrolled active infection - Your heart function (ejection fraction) is below 50% on echocardiogram 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGDecitabine, venetoclax and blinatumomab

Cycle1 and cycle3: Decitabine monotherapy,20 mg/m2 qd, d1-5,intravenous infusion; Cycle2 and cycle4: Venetoclax 200mg qd, d1-14, orally; Blinatumomab d4-17(Weight ≥45 kg, 9ug d4-6, 28ug d7-17; Weight \<45 kg, 5ug/m2 d4-6, 15ug/m2 d7-17;continuous intravenous infusion)


Locations(1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06393985


Related Trials