NCT06393985RecruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 19 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 27 Apr 2024
- Start date
- 25 Apr 2024
- Primary completion date
- 25 Apr 2026
- Lead sponsor
- The First Affiliated Hospital of Soochow University
- Diseases
- Acute lymphoblastic leukaemia
- NCT number
- NCT06393985
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 30
- From 25 Apr 2024 to the primary completion date, 25 Apr 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- 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.
Who the study is looking for
- 1.Philadelphia chromosome-negative B-cell acute lymphoblastic leukemia who underwent an alloHSCT as follows:
- patients in CR1 with high-risk features,including adverse clinical features, cytogenetic or molecular alterations according to NCCN 2023.V3.
- patients lack of achievement of complete remission after standard induction chemotherapy.
- patients with detectable minimal residual disease pre-transplantation.
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of Soochow University Coordinator of this site? Confirm its status | Suzhou | China | Recruiting |
Related publications
- Immunotherapy in B-Cell Acute Lymphoblastic Leukemia.J Natl Compr Canc Netw · 2025 · PMID 41671463
This page is information, not medical advice. Discuss any trial with your doctor.