PMID- 32414392 OWN - NLM STAT- MEDLINE DCOM- 20210125 LR - 20210125 IS - 1756-8722 (Electronic) IS - 1756-8722 (Linking) VI - 13 IP - 1 DP - 2020 May 15 TI - Comparison of haplo-SCT and chemotherapy for young adults with standard-risk Ph-negative acute lymphoblastic leukemia in CR1. PG - 52 LID - 10.1186/s13045-020-00879-1 [doi] LID - 52 AB - Human leukocyte antigen (HLA) haploidentical stem cell transplantation (haplo-SCT) as a postremission treatment for standard risk Philadelphia chromosome-negative acute lymphoblastic leukemia (SR Ph-ALL) in the first complete remission (CR1) has not been defined. In this multicenter, phase 3 study (NCT02042690), of the 131 consecutive Ph-ALL young adult patients (YA, aged 18-39 years) without high-risk features who achieved CR1, 114 patients without HLA-matched donors received consolidation with an adult chemotherapy regimen (n = 55) or haplo-SCT (n = 59). In the landmark analysis, haplo-SCT resulted in a lower 2-year cumulative incidence of relapse (CIR, 12.8% vs 46.7%, P = 0.0017) and superior 2-year leukemia-free survival (LFS, 80.9% vs 51.1%, P = 0.0116) and 2-year overall survival (OS, 91.2% vs 75.7 [64.8-93.2] %, P = 0.0408) than chemotherapy. In the time-dependent multivariate analysis with propensity score adjustment, postremission treatment (haplo-SCT vs chemotherapy) was an independent risk factor for the CIR (HR 0.195, 95% CI 0.076-0.499, P = 0.001), LFS (HR 0.297, 95% CI 0.131-0.675, P = 0.003), and OS (HR 0.346, 95% CI 0.140-0.853, P = 0.011). In all subgroups, CIR was lower in haplo-SCT. Myeloablative haplo-SCT with ATG+G-CSF might be one of the preferred therapies for YA patients with standard-risk Ph-ALL. TRIAL REGISTRATION: ClinicalTrials.gov. Registered on 23 January 2014, https://clinicaltrials.gov/ct2/show/NCT02042690. FAU - Lv, Meng AU - Lv M AD - Peking University People's Hospital, Peking University Institute of Hematology, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation, National Clinical Research Center for Hematologic Disease, Beijing, China. FAU - Jiang, Qian AU - Jiang Q AD - Peking University People's Hospital, Peking University Institute of Hematology, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation, National Clinical Research Center for Hematologic Disease, Beijing, China. FAU - Zhou, Dao-Bin AU - Zhou DB AD - Peking Union Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. FAU - Hu, Yu AU - Hu Y AD - Wuhan Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. FAU - Liu, Dai-Hong AU - Liu DH AD - General Hospital of PLA (People's Liberation Army of China), Beijing, China. FAU - Wu, De-Pei AU - Wu DP AD - The First Affiliated Hospital of Soochow University, National Clinical Research Center for Hematologic Disease, Suzhou, China. FAU - Wang, Jing-Bo AU - Wang JB AD - Peking University Aerospace Center Hospital, Beijing, China. FAU - Jiang, Hao AU - Jiang H AD - Peking University People's Hospital, Peking University Institute of Hematology, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation, National Clinical Research Center for Hematologic Disease, Beijing, China. FAU - Wang, Jing AU - Wang J AD - Peking University People's Hospital, Peking University Institute of Hematology, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation, National Clinical Research Center for Hematologic Disease, Beijing, China. FAU - Chang, Ying-Jun AU - Chang YJ AD - Peking University People's Hospital, Peking University Institute of Hematology, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation, National Clinical Research Center for Hematologic Disease, Beijing, China. FAU - Wang, Yu AU - Wang Y AD - Peking University People's Hospital, Peking University Institute of Hematology, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation, National Clinical Research Center for Hematologic Disease, Beijing, China. FAU - Zhang, Xiao-Hui AU - Zhang XH AD - Peking University People's Hospital, Peking University Institute of Hematology, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation, National Clinical Research Center for Hematologic Disease, Beijing, China. FAU - Xu, Lan-Ping AU - Xu LP AD - Peking University People's Hospital, Peking University Institute of Hematology, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation, National Clinical Research Center for Hematologic Disease, Beijing, China. FAU - Liu, Kai-Yan AU - Liu KY AD - Peking University People's Hospital, Peking University Institute of Hematology, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation, National Clinical Research Center for Hematologic Disease, Beijing, China. FAU - Huang, Xiao-Jun AU - Huang XJ AUID- ORCID: 0000-0002-2145-6643 AD - Peking University People's Hospital, Peking University Institute of Hematology, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation, National Clinical Research Center for Hematologic Disease, Beijing, China. xjhrm@medmail.com.cn. AD - Peking-Tsinghua Center for Life Sciences, Beijing, China. xjhrm@medmail.com.cn. AD - Research Unit of Key Technique for Diagnosis and Treatments of Hematologic Malignancies (2019RU029), Chinese Academy of Medical Sciences, Beijing, China. xjhrm@medmail.com.cn. LA - eng SI - ClinicalTrials.gov/NCT02042690 PT - Clinical Trial, Phase III PT - Comparative Study PT - Letter PT - Multicenter Study PT - Research Support, Non-U.S. Gov't DEP - 20200515 PL - England TA - J Hematol Oncol JT - Journal of hematology & oncology JID - 101468937 RN - 0 (Antineoplastic Agents) SB - IM MH - Adolescent MH - Adult MH - Antineoplastic Agents/*therapeutic use MH - Disease-Free Survival MH - *Hematopoietic Stem Cell Transplantation MH - Humans MH - Incidence MH - Neoplasm Recurrence, Local/diagnosis/etiology MH - Philadelphia Chromosome MH - Precursor Cell Lymphoblastic Leukemia-Lymphoma/drug therapy/genetics/*therapy MH - Remission Induction MH - *Transplantation, Haploidentical MH - Young Adult PMC - PMC7227076 OTO - NOTNLM OT - Adult chemotherapy OT - Haplo-SCT OT - Ph-negative acute lymphoblastic leukemia COIS- The authors declare that they have no competing interests. EDAT- 2020/05/18 06:00 MHDA- 2021/01/26 06:00 PMCR- 2020/05/15 CRDT- 2020/05/17 06:00 PHST- 2020/03/11 00:00 [received] PHST- 2020/04/23 00:00 [accepted] PHST- 2020/05/17 06:00 [entrez] PHST- 2020/05/18 06:00 [pubmed] PHST- 2021/01/26 06:00 [medline] PHST- 2020/05/15 00:00 [pmc-release] AID - 10.1186/s13045-020-00879-1 [pii] AID - 879 [pii] AID - 10.1186/s13045-020-00879-1 [doi] PST - epublish SO - J Hematol Oncol. 2020 May 15;13(1):52. doi: 10.1186/s13045-020-00879-1.