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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.
Patients with acute B-cell lymphoblastic leukemia who relapsed after receiving allogeneic hematopoietic stem cell transplantation in our hospital and received sequential donor lymphocyte infusion (DLI) treatment after relapse. The patients with acute B-cell lymphoblastic leukemia who relapsed after receiving allogeneic hematopoietic stem cell transplantation in our hospital from September 2023 to December 2026 and received sequential donor lymphocyte infusion (DLI) treatment after relapse were enrolled.
Exclusion criteria
MRD-positive patients were given Blinatumomab 28μg×5-15 days, followed by DLI treatment (infusion of MNC is about 5×10^7/kg~1×10^8/kg).
Hematologic relapse patients were given Blinatumomab 9μg d1-4,11.66μg d5-7,28μg d8 (a total of 8 to 21 days), followed by DLI treatment (infusion of MNC is about 5×10^7/kg~1×10^8/kg). The duration of using Blinatumomab was determined according to the patient's tolerance, economic situation and other comprehensive factors.
Main observation and statistical indicators Overall survival after relapse, disease-free survival, incidence of cytokine release syndrome (CRS), incidence of acute/chronic graft-versus-host disease (GVHD) after treatment, incidence of infection, incidence of hematological adverse reactions, etc.Compared with patients receiving usual care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blinatumomab followed by donor lymphocyte infusion | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blinatumomab | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Survival time of patients with recurrence after treatment | three years |
| Disease-free survival | Disease-free survival time after treatment for relapsed patients | three years |
| Measure | Description | Time Frame |
|---|---|---|
| incidence of cytokine release syndrome (CRS) | Recurrent patients received treatment 2 weeks later | 2 weeks later |
| Incidence of acute/chronic graft-versus-host disease (GVHD) | Recurrent patients received treatment 100 days later. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Suping ZHANG | Contact | +8613523510641 | zsp198612@163.com | |
| Zhilei BIAN | Contact | 0371-66862272 |
| Name | Affiliation | Role |
|---|---|---|
| Zhilei BIAN | The First Affiliated Hospital of Zhengzhou University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Zhengzhou University | Recruiting | Zhenzhou | Henan | 450000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41671463 | Derived | Davis KL, Yao CC, Zimmerman JAO, Rau RE. Immunotherapy in B-Cell Acute Lymphoblastic Leukemia. J Natl Compr Canc Netw. 2025 Dec;23(12):e257067. doi: 10.6004/jnccn.2025.7067. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 15, 2023 | Mar 27, 2024 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 15, 2023 | Mar 19, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C510808 | blinatumomab |
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| 2 weeks later |
| hematological adverse reactions Incidence rate | Recurrent patients received treatment 2 weeks later. | 2 weeks later |