PMID- 34274491
OWN - NLM
STAT- MEDLINE
DCOM- 20220125
LR  - 20220125
IS  - 2666-6367 (Electronic)
IS  - 2666-6367 (Linking)
VI  - 27
IP  - 11
DP  - 2021 Nov
TI  - A Phase I/II Multicenter Trial of HLA-Haploidentical PBSCT with PTCy for 
      Aggressive Adult T Cell Leukemia/Lymphoma.
PG  - 928.e1-928.e7
LID - S2666-6367(21)01075-7 [pii]
LID - 10.1016/j.jtct.2021.07.010 [doi]
AB  - Adult T cell leukemia/lymphoma (ATL) is a highly aggressive hematologic 
      malignancy with a very poor prognosis, and most patients with ATL are elderly. 
      Although post-transplantation cyclophosphamide (PTCy) has yielded promising 
      results in various diseases, available data are limited regarding its outcomes in 
      ATL. The aim of this study was to determine the safety and efficacy of 
      reduced-intensity peripheral blood stem cell transplantation (PBSCT) from a human 
      leukocyte antigen (HLA)-haploidentical donor using PTCy as graft-versus-host 
      disease (GVHD) prophylaxis. This was a prospective, multicenter phase I/II study 
      (UMIN000021783) conducted at 16 hospitals in Japan. The primary endpoint was the 
      probability of survival with engraftment and without grade III/IV acute GVHD at 
      day 60 after PBSCT. The expected probability of the primary endpoint was 
      estimated to be 60%, and the threshold probability was set at 30% on the basis of 
      previous studies. The conditioning regimen consisted of fludarabine (30 mg/m(2)/d 
      from day -7 to -2), melphalan (40 mg/m(2)/d on days -3 and -2), and total body 
      irradiation (2 Gy on day -1). GVHD prophylaxis consisted of tacrolimus starting 
      at 0.02 mg/kg/d on day -1, PTCy (50 mg/kg/d on days +3 and +5), and mycophenolate 
      mofetil 2000 mg/d starting on day +6. Eighteen ATL patients underwent PBSCT. The 
      probability of patients who met the primary endpoint was 89% (95% confidence 
      interval, 65% to 99%). The cumulative incidences of grade II to IV acute GVHD, 
      III/IV acute GVHD, and moderate-to-severe chronic GVHD were 39%, 11%, and 17%, 
      respectively. The probabilities of overall survival were 83% at 1 year and 73% at 
      2 years. The cumulative incidences of non-relapse mortality and disease 
      progression at 1 year were 11% and 28%, respectively. HLA-haploidentical PBSCT 
      with PTCy as GVHD prophylaxis is a valid option for patients with aggressive ATL.
CI  - Copyright (c) 2021 The American Society for Transplantation and Cellular Therapy. 
      Published by Elsevier Inc. All rights reserved.
FAU - Tanaka, Takashi
AU  - Tanaka T
AD  - Department of Hematopoietic Stem Cell Transplantation, National Cancer Center 
      Hospital, Tokyo, Japan.
FAU - Nakamae, Hirohisa
AU  - Nakamae H
AD  - Hematology, Graduate School of Medicine, Osaka City University, Osaka, Japan.
FAU - Ito, Ayumu
AU  - Ito A
AD  - Department of Hematopoietic Stem Cell Transplantation, National Cancer Center 
      Hospital, Tokyo, Japan.
FAU - Fuji, Shigeo
AU  - Fuji S
AD  - Department of Hematology, Osaka International Cancer Institute, Osaka, Japan.
FAU - Hirose, Asao
AU  - Hirose A
AD  - Hematology, Graduate School of Medicine, Osaka City University, Osaka, Japan.
FAU - Eto, Tetsuya
AU  - Eto T
AD  - Department of Hematology, Hamanomachi Hospital, Fukuoka, Japan.
FAU - Henzan, Hideho
AU  - Henzan H
AD  - Department of Hematology, Hamanomachi Hospital, Fukuoka, Japan.
FAU - Takase, Ken
AU  - Takase K
AD  - Department of Hematology, National Hospital Organization Kyushu Medical Center, 
      Fukuoka, Japan.
FAU - Yamasaki, Satoshi
AU  - Yamasaki S
AD  - Department of Hematology, National Hospital Organization Kyushu Medical Center, 
      Fukuoka, Japan.
FAU - Makiyama, Junya
AU  - Makiyama J
AD  - Department of Hematology, Sasebo City General Hospital, Sasebo, Japan.
FAU - Moriuchi, Yukiyoshi
AU  - Moriuchi Y
AD  - Department of Hematology, Sasebo City General Hospital, Sasebo, Japan.
FAU - Choi, Ilseung
AU  - Choi I
AD  - Department of Hematology, National Hospital Organization Kyushu Cancer Center, 
      Fukuoka, Japan.
FAU - Nakano, Nobuaki
AU  - Nakano N
AD  - Department of Hematology, Imamura General Hospital, Kagoshima, Japan.
FAU - Hiramoto, Nobuhiro
AU  - Hiramoto N
AD  - Department of Hematology, Kobe City Medical Center General Hospital, Kobe, Japan.
FAU - Kato, Koji
AU  - Kato K
AD  - Department of Hematology, Oncology & Cardiovascular Medicine, Kyushu University 
      Hospital, Fukuoka, Japan.
FAU - Sato, Takahiko
AU  - Sato T
AD  - Department of Hematology, Japanese Red Cross Nagoya First Hospital, Nagoya, 
      Japan.
FAU - Sawayama, Yasushi
AU  - Sawayama Y
AD  - Department of Hematology, Sasebo University Hospital, Sasebo, Japan.
FAU - Kim, Sung-Won
AU  - Kim SW
AD  - Department of Hematopoietic Stem Cell Transplantation, National Cancer Center 
      Hospital, Tokyo, Japan.
FAU - Inoue, Yoshitaka
AU  - Inoue Y
AD  - Department of Hematopoietic Stem Cell Transplantation, National Cancer Center 
      Hospital, Tokyo, Japan.
FAU - Inamoto, Yoshihiro
AU  - Inamoto Y
AD  - Department of Hematopoietic Stem Cell Transplantation, National Cancer Center 
      Hospital, Tokyo, Japan.
FAU - Fukuda, Takahiro
AU  - Fukuda T
AD  - Department of Hematopoietic Stem Cell Transplantation, National Cancer Center 
      Hospital, Tokyo, Japan. Electronic address: tafukuda@ncc.go.jp.
LA  - eng
PT  - Clinical Trial, Phase I
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20210715
PL  - United States
TA  - Transplant Cell Ther
JT  - Transplantation and cellular therapy
JID - 101774629
RN  - 0 (HLA Antigens)
RN  - 8N3DW7272P (Cyclophosphamide)
SB  - IM
MH  - Aged
MH  - Cyclophosphamide/therapeutic use
MH  - HLA Antigens
MH  - *Hematopoietic Stem Cell Transplantation
MH  - Humans
MH  - *Leukemia-Lymphoma, Adult T-Cell/therapy
MH  - *Lymphoma
MH  - *Peripheral Blood Stem Cell Transplantation
MH  - Prospective Studies
OTO - NOTNLM
OT  - Adult T cell leukemia/lymphoma
OT  - Allogeneic
OT  - Haploidentical
OT  - Peripheral blood stem cell transplantation
OT  - Posttransplant cyclophosphamide
EDAT- 2021/07/19 06:00
MHDA- 2022/01/27 06:00
CRDT- 2021/07/18 20:37
PHST- 2021/04/23 00:00 [received]
PHST- 2021/06/23 00:00 [revised]
PHST- 2021/07/08 00:00 [accepted]
PHST- 2021/07/19 06:00 [pubmed]
PHST- 2022/01/27 06:00 [medline]
PHST- 2021/07/18 20:37 [entrez]
AID - S2666-6367(21)01075-7 [pii]
AID - 10.1016/j.jtct.2021.07.010 [doi]
PST - ppublish
SO  - Transplant Cell Ther. 2021 Nov;27(11):928.e1-928.e7. doi: 
      10.1016/j.jtct.2021.07.010. Epub 2021 Jul 15.