Status:
UNKNOWN
Anti-CD19 CAR-T Therapy Bridging to HSCT for CD19+ B-Cell Malignancies
Lead Sponsor:
Wuhan Sian Medical Technology Co., Ltd
Collaborating Sponsors:
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Jingzhou Central Hospital
Conditions:
Acute Lymphoblastic Leukemia
B Cell Lymphoma
Eligibility:
All Genders
Up to 70 years
Phase:
PHASE1
PHASE2
Brief Summary
This is the second stage of the previous anti-CD19 CAR-T therapy (NCT02965092). The study aims to evaluate the safety and efficacy of consolidative allo-HSCT following CAR-T therapy in patients with r...
Detailed Description
Anti-CD19 CAR-T therapy has been confirmed effective for relapsed/refractory B-cell malignancies. However, its ability to keep patients in maintained remission is limited. In order to keep patients in...
Eligibility Criteria
Inclusion
- The patient is pathologically and histologically confirmed as CD19 + B cell malignancies, and has achieved MRD-negative CR through CAR-T therapy (NCT02965092);
- 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);
- \< 70 years old;
- Expected survival time \> 6 months;
- Female patients around childbearing age, negative pregnancy test before trial, and agreed to take effective contraceptive measures during the trial until the last visit;
- Voluntarily participate in this experiment and sign informed consent by themselves, or legally authorized representative.
Exclusion
- With a history of epilepsy or other central nervous system diseases;
- Previous allogeneic hematopoietic stem cell transplantation;
- 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);
- Pregnant or lactating women (safety of this therapy for the unborn child is unknown);
- Not curable active infection;
- Patients with active hepatitis B or hepatitis C virus infection;
- Combined use of systemic steroids within two weeks (except use of inhaled steroid recently or currently);
- 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);
- Patients suffering from other uncontrolled diseases, and researchers believe that the patient is not suitable for trial;
- Patients with HIV-infection;
- Any situation that may increase the risk of patients or interfere with test results.
Key Trial Info
Start Date :
April 15 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2021
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03366350
Start Date
April 15 2016
End Date
June 1 2021
Last Update
May 10 2019
Active Locations (1)
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1
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China