Anti-CD19 CAR-T Therapy Bridging to HSCT for CD19+ B-Cell Malignancies
NCT ID: NCT03366350
Last Updated: 2019-05-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
50 participants
INTERVENTIONAL
2016-04-15
2021-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Consolidative allo-HSCT following CAR-T therapy
Patients who had achieved MRD-negative complete remissions through CAR-T therapy (NCT02965092) will, on their own accord, receive allo-HSCT if there are no previous HSCT, contraindications, and other restrictions.
Allogeneic hematological stem cell transplantation
Patients receive allogeneic hematological stem cell transplantation after they achieve MRD- CR through CAR-T therapy.
Interventions
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Allogeneic hematological stem cell transplantation
Patients receive allogeneic hematological stem cell transplantation after they achieve MRD- CR through CAR-T therapy.
Eligibility Criteria
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Inclusion Criteria
2. B cell hematological malignancies include the following three categories:
* B-cell acute lymphocytic leukemia (B-ALL);
* Indolent B-cell lymphoma (CLL, FL, MZL, LPL);
* Aggressive B-cell lymphoma (DLBCL, BL, MCL);
3. \< 70 years old;
4. Expected survival time \> 6 months;
5. Female patients around childbearing age, negative pregnancy test before trial, and agreed to take effective contraceptive measures during the trial until the last visit;
6. Voluntarily participate in this experiment and sign informed consent by themselves, or legally authorized representative.
Exclusion Criteria
2. Previous allogeneic hematopoietic stem cell transplantation;
3. The presence of clinically significant cardiovascular disease, such as uncontrolled or symptomatic arrhythmias, congestive heart failure or myocardial infarction within recent six months, or heart disease with cardiac function in any grade 3 (moderate) or 4 ( severe) (according to the New York Heart Association (NYHA) Functional Classification System);
4. Pregnant or lactating women (safety of this therapy for the unborn child is unknown);
5. Not curable active infection;
6. Patients with active hepatitis B or hepatitis C virus infection;
7. Combined use of systemic steroids within two weeks (except use of inhaled steroid recently or currently);
8. Creatinine\> 2.5 mg / dl (221.0 umol/L); ALT / AST\> 3 X the normal amount; Bilirubin\> 2.0 mg / dl (34.2 umol/L);
9. Patients suffering from other uncontrolled diseases, and researchers believe that the patient is not suitable for trial;
10. Patients with HIV-infection;
11. Any situation that may increase the risk of patients or interfere with test results.
70 Years
ALL
No
Sponsors
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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
OTHER
Jingzhou Central Hospital
OTHER
Xiangyang Central Hospital
OTHER
People Hospital Of Yichang
UNKNOWN
Wuhan Sian Medical Technology Co., Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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YU HU, M.D., Ph.D
Role: PRINCIPAL_INVESTIGATOR
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Locations
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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Countries
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Central Contacts
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Facility Contacts
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References
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Du M, Mayombo RTM, Liu J, Zhang Y, Liao D, Hu Y, Mei H. The impact of obesity and its related underlying diseases on cytokine release syndrome and the efficacy of CAR-T therapy in treating B-cell malignancies. Ann Hematol. 2025 Mar;104(3):1887-1895. doi: 10.1007/s00277-025-06338-6. Epub 2025 Apr 8.
Other Identifiers
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CART-CD19-02
Identifier Type: -
Identifier Source: org_study_id
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