Anti‐CD19 chimeric antigen receptor‐modified T‐cell therapy bridging to allogeneic hematopoietic stem cell transplantation for relapsed/refractory B‐cell acute lymphoblastic leukemia: An open‐label pragmatic clinical trial

Chimeric antigen receptor‐modified T‐cell (CAR‐T) therapy is effective and safe for patients with relapsed/refractory B‐cell acute lymphoblastic leukemia (r/r B‐ALL), but its value has been limited in terms of long‐term leukemia‐free survival. New strategies that can help CAR‐T therapy achieve lasti...

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Bibliographic Details
Published in:American journal of hematology 2019-10, Vol.94 (10), p.1113-1122
Main Authors: Jiang, Huiwen, Li, Chenggong, Yin, Ping, Guo, Tao, Liu, Lin, Xia, Linghui, Wu, Yaohui, Zhou, Fen, Ai, Lisha, Shi, Wei, Lu, Xuan, Wang, Huafang, Tang, Lu, Wei, Qiuzhe, Deng, Jun, Jin, Runming, Xiong, Wei, Dong, Jian, Mei, Heng, Hu, Yu
Format: Article
Language:English
Subjects:
Acute lymphoblastic leukemia
Adolescent
Adult
Aged
Allografts
Antigens
Antigens, CD19 - immunology
Bone marrow
Bone Marrow - pathology
Bone Marrow Transplantation
CD19 antigen
Chemotherapy
Child
Child, Preschool
Chimeric antigen receptors
Clinical trials
Disease-Free Survival
Female
Flow cytometry
Hematology
Hematopoietic stem cells
Humans
Immunosuppressive Agents - therapeutic use
Immunotherapy, Adoptive
Infant
Leukemia
Lymphatic leukemia
Lymphocyte Depletion
Lymphocytes B
Lymphocytes T
Male
Medical prognosis
Middle Aged
Minimal residual disease
Neoplasm, Residual
Peripheral Blood Stem Cell Transplantation
Precursor Cell Lymphoblastic Leukemia-Lymphoma - genetics
Precursor Cell Lymphoblastic Leukemia-Lymphoma - pathology
Precursor Cell Lymphoblastic Leukemia-Lymphoma - therapy
Prognosis
Progression-Free Survival
Recurrence
Remission
Salvage Therapy
Stem cell transplantation
Stem cells
Transplantation Conditioning
Young Adult
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Summary:Chimeric antigen receptor‐modified T‐cell (CAR‐T) therapy is effective and safe for patients with relapsed/refractory B‐cell acute lymphoblastic leukemia (r/r B‐ALL), but its value has been limited in terms of long‐term leukemia‐free survival. New strategies that can help CAR‐T therapy achieve lasting effect are urgently warranted. This non‐randomized interventional pragmatic clinical trial had a particular aim. It explored whether consolidative allogeneic hematopoietic stem cell transplantation (allo‐HSCT) could improve the long‐term prognosis of the minimal residual disease‐negative complete remission (MRD− CR) patients after CAR‐T therapy. In the first stage, 58 r/r B‐ALL patients received split doses of CAR‐T cells after lymphodepleting chemotherapy, and 51 (87.9%) achieved CR. In the second stage, 21/47 MRD− CR patients without previous allo‐HSCT and contraindications or other restrictions, on their own accord, received consolidative allo‐HSCT within three months after CAR‐T therapy. There was no difference in overall survival (OS) between the MRD− CR patients who received allo‐HSCT and those who did not. However, event‐free survival (EFS) and relapse‐free survival (RFS) were significantly prolonged by allo‐HSCT in the subgroups. This was with either high (≥5%) pre‐infusion bone marrow MRD assessed by flow cytometry (BM‐FCM‐MRD) or poor prognostic markers (P 
ISSN:0361-8609
1096-8652
DOI:10.1002/ajh.25582