For micro residual disease (MRD) positive patients who have undergone at least 2 cycles chemotherapies for their CD19+ B-cell malignancies, there would be much more risks for them to receive hematological stem cell transplantation (HSCT) than MRD- patients. In order to reduce HSCT-related adverse events for these kind of patients, investigators plan to conduct CAR-T therapies on them first to make them achieve MRD- statuses, and then transfer them to HSCT.
In order to improve prognoses for MRD+ patients who have undergone at least 2 cycles chemotherapies, patients will receive CAR-T therapy before HSCT, once they achieve MRD- remissions, they will subsequently receive HSCT if there are no contraindications.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Patients receive CD19 CAR-T cells transduced with a lentiviral vector on days 0, 1, and 2.
Patients receive hematological stem cell transplantations within 3 months after they achieve MRD- remissions after CAR-T therapies.
Institute of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
RECRUITINGOccurrence of study related adverse events
defined as \>= Grade 3(NCI CTCAE version 4.03) signs/symptoms, laboratory toxicities, and clinical events that are possibly, likely, or definitely related to study treatment
Time frame: 200 days from enrollment
Number of participants with an MRD negative complete remission after CAR-T therapy and HSCT
the efficacy of the combination of CAR-T therapy and HSCT will be estimated based on the number of participants who have an MRD negative (flow cytometry) bone marrow aspirate following the treatment
Time frame: 2 years from enrollment
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