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| Name | Class |
|---|---|
| Fujian Medical University Union Hospital | OTHER |
| Zhongda Hospital | OTHER |
| The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | OTHER |
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To explore the efficacy and safty of Blinatumomab as a bridge to Allogeneic Hematopoietic Stem Cell Transplantation in High Risk Precursor B-cell Acute Lymphoblastic Leukemia
High Risk Precursor B-cell Acute Lymphoblastic Leukemia is a kind of leukemia with poor prognosis. Here, we want to explore the efficacy and safty of Blinatumomab as a bridge to Allogeneic Hematopoietic Stem Cell Transplantation in High Risk Precursor B-cell Acute Lymphoblastic Leukemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blinatumomab arm | Experimental | On the 1st to 3rd day, Blinatumomab should be continuous intravenous use for 24 hours with 9ug/ day for those whose weight are equal to or greater than 45kg, and 5ug/ m2 / day for those whose weight are less than 45kg (maximum dosage is 9ug/ day) per 24 hours. On the 4th to 14th day, for the patients who are equal to or greater than 45kg, they will receive Blinatumomab at the dose of 28ug/ day with continuous intravenous administration, and those below 45kg are given a 24h continuous infusion of 15ug/ m2 / day (maximum dose is 28ug/ day). Bucy-based myeloablative conditioning regimen will be performed on the 15th day. |
|
| Conventional therapy | Other | Bucy-based myeloablative conditioning regimen will be given to those patients are enrolled into control group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blinatumomab | Drug | Blinatumomab will be bridged to conventional BUCY conditioning regimen. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | The time from randomization to death from any cause. | From the 1st day to the 720th days after enrollment. |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients with negative minimal residual disease (MRD) | Negative MRD is defined as below 10-4 by flow cytometry. | From the 1st day to the 720th days after enrollment. |
| Progression-Free Survival (PFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huizhu Kang, MD | Contact | 18761925608 | khz11826@sina.com | |
| Meng Zhou, MD | Contact | 15606133002 | zhoumeng@suda.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Yue Han, MD/PhD | The First Affiliated Hospital of Soochow University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The first affiliated hospital of Soochow University | Recruiting | Suzhou | Jiangsu | 215000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29358182 | Background | Gokbuget N, Dombret H, Bonifacio M, Reichle A, Graux C, Faul C, Diedrich H, Topp MS, Bruggemann M, Horst HA, Havelange V, Stieglmaier J, Wessels H, Haddad V, Benjamin JE, Zugmaier G, Nagorsen D, Bargou RC. Blinatumomab for minimal residual disease in adults with B-cell precursor acute lymphoblastic leukemia. Blood. 2018 Apr 5;131(14):1522-1531. doi: 10.1182/blood-2017-08-798322. Epub 2018 Jan 22. | |
| 41671463 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Sep 20, 2021 | Sep 26, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D002051 | Burkitt Lymphoma |
| ID | Term |
|---|---|
| D020031 | Epstein-Barr Virus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| C510808 | blinatumomab |
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| The First People's Hospital of Changzhou |
| OTHER |
| Wuxi People's Hospital | OTHER |
| First Affiliated Hospital of Wannan Medical College | OTHER |
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| Conventional therapy | Other | Control group will be given conventional BUCY conditioning regimen. |
|
It is defined as the total survival of a patient after the hematopoietic stem cell transplantation, until the tumor recurrence or death from any cause.
| From the 1st day to the 720th days after enrollment. |
| Cumulative incidence of relapse (CIR) | From hematopoietic stem cell transplantation to recurrence, relapse-free death was considered a competing risk event. | From the 1st day to the 720th days after enrollment. |
| 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. |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |