NCT06339775RecruitingPhase 4
Blinatumomab for Relapsed Acute B Lymphoblastic Leukemia After Transplantation
Blinatumomab Sequential Donor Lymphocyte Infusion in Acute B Lymphocytic Leukemia Observation of Therapeutic Effect in Patients With Recurrence After Allogeneic Hematopoietic Stem Cell Transplantation
Source: ClinicalTrials.gov · Last updated 1 Apr 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
B-ALL patients received regular follow-up after allogeneic hematopoietic stem cell transplantation, and in case of recurrence, they were given Blinatumomab. Anti-treatment was followed by DLI, and the second course was performed 1-2 months after DLI. Patients with positive MRD were treated with Blinatumomab 28μg×5-15 days, followed by DLI treatment. (MNC infusion is about 5×10\^7/kg\~1×10\^8/kg). Patients with hematologic recurrence were given Blinatumomab 9μg D1-4,11.66μg d5-7,28μg Starting from d8 （8 to 21 days in total）, followed by DLI treatment (infusion of MNC approximately 5×10\^7/kg\~1×10\^8/kg). Objective To observe and analyze the efficacy and side effects of Blinatumomab followed by donor lymphocyte infusion in patients with relapsed acute B lymphoblastic leukemia after allogeneic hematopoietic stem cell transplantation in our hospital.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 18 Mar 2024
- Start date
- 1 Sept 2023
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Suping ZHANG
- NCT number
- NCT06339775
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 60
- From 1 Sept 2023 to the primary completion date, 31 Dec 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.
Other illness
- Complicated with severe infection
- Combined with grade Ⅱ-Ⅳ graft-versus-host disease
- Heart, liver, kidney and other organ failure
- Allergies to medications in the treatment regimen
Age
- Age \> 65 years old
Other
- Unstable vital signs
- Complicated with central nervous system leukemia
Who the study is looking for
- Age ≤65 years old
- Stable vital signs
- No severe infection
- There was no grade II-IV graft-versus-host disease
- No organ failure
Age in the registry: - 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 Zhengzhou University Coordinator of this site? Confirm its status | Zhenzhou | 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.