NCT06393985 Decitabine, Venetoclax and Blinatumomab for Maintenance Following HSCT in Patients With Ph-Negative B-ALL
| NCT ID | NCT06393985 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | The First Affiliated Hospital of Soochow University |
| Condition | B-cell Acute Lymphoblastic Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-04-25 |
| Primary Completion | 2026-04-25 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 30 participants in total. It began in 2024-04-25 with a primary completion date of 2026-04-25.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 1.Philadelphia chromosome-negative B-cell acute lymphoblastic leukemia who underwent an alloHSCT as follows: 1. patients in CR1 with high-risk features,including adverse clinical features, cytogenetic or molecular alterations according to NCCN 2023.V3. 2. patients lack of achievement of complete remission after standard induction chemotherapy. 3. patients with detectable minimal residual disease pre-transplantation. 4. patients in second and higher CR pre-transplantation. 2.Negative minimal residual disease prior to enrollment (FCM-MRD \<0.01% and fusion gene negative). 3.≥3 months post-transplantation. 4.hematopoietic reconstitution, i.e., ANC ≥0.5 x 109/L, and platelets \>20 x 109/L. 5.Eastern Cooperative Oncology Group (ECOG) score: 0-2. 6.Total serum bilirubin ≤ 3 x upper limit of normal (ULN), alanine aminotransferase (ALT) ≤ 5 x ULN, aspartate aminotransferase (AST) ≤ 5 x ULN. 7.Creatinine clearance ≥ 30 mL/min. 8.Provide informed consent. Exclusion Criteria: * 1.Patients with another malignant disease. 2.Patients with uncontrolled active infection. 3.Patients with left ventricular ejection fraction \< 0.5 by echocardiography or grade III/IV cardiovascular dysfunction according to the New York Heart Association Classification. 4.Detectable minimal residual disease post-transplantation 5.Active GVHD requiring systemic steroid therapy. 6.Patients with uncontrolled active bleeding. 7.Pregnant and lactating women; patients of childbearing potential should be willing to practice methods of contraception throughout the study period. 8.Patients with other commodities that the investigators considered not suitable for the enrollment.
Contact & Investigator
Xiaowen Tang, Ph.D
STUDY CHAIR
The First Affiliated Hospital of Soochow University
Frequently Asked Questions
Who can join the NCT06393985 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying B-cell Acute Lymphoblastic Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06393985 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06393985 currently recruiting?
Yes, NCT06393985 is actively recruiting participants. Contact the research team at xwtang1020@163.com for enrollment information.
Where is the NCT06393985 trial being conducted?
This trial is being conducted at Suzhou, China.
Who is sponsoring the NCT06393985 clinical trial?
NCT06393985 is sponsored by The First Affiliated Hospital of Soochow University. The principal investigator is Xiaowen Tang, Ph.D at The First Affiliated Hospital of Soochow University. The trial plans to enroll 30 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.