A phase II study of post-transplant cyclophosphamide combined with tacrolimus for GVHD prophylaxis after HLA-matched related/unrelated allogeneic hematopoietic stem cell transplantation
A phase II study of post-transplant cyclophosphamide combined with tacrolimus for GVHD prophylaxis after HLA-matched related/unrelated allogeneic hematopoietic stem cell transplantation
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移植后环磷酰胺联合他克莫司预防 HLA 匹配相关/非相关同种异体造血干细胞移植后 GVHD 的 II 期研究
DOI：
10.1007/s12185-021-03228-1
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发表时间：
2022
期刊：
影响因子：
--
通讯作者：
Hino M
中科院分区：
文献类型：
--
作者：
Nakamae H;Nakane T;Okamura H;Koh H;Nakashima Y;Hirose A;Nakamae M;Nishimoto M;Kuno M;Makuuchi Y;Harada N;Takakuwa T;Hino M
三种移植后药物，环磷酰胺（PTC y），钙调磷酸酶抑制剂，和霉酚酸酯的组合，长期以来一直用于预防HLA-半相合异基因造血细胞移植（allo-HCT）后的移植物抗宿主病（GVHD）。最近，这种组合也被用于HLA匹配的allo-HCT，但在HLA匹配的情况下用于GVHD预防的最佳药物组合仍不清楚。这项前瞻性II期研究评价了来自HLA匹配的相关供体（MRD）或HLA匹配的无关供体（MUD）的allo-HCT后PTCy加他克莫司（TAC）预防GVHD的安全性和有效性。移植后100天，MRD组中II-IV级和III-IV级急性GVHD的累积发生率分别为18%和5.9%，MUD组中分别为18%和9.1%。MRD组和MUD组1年时中度至重度慢性GVHD的累积发生率分别为12%和9.1%。MRD组和MUD组的1年总生存率分别为88%和64%，1年无GVHD和无复发生存率分别为59%和50%。这些结果表明，GVHD预防与较低强度的双重药物组合，（PT/Cy和TAC）在HLA匹配的allo-HCT后可能是可行的。临床试验注释本试验是在大学医院医学信息网络临床试验注册处注册的前瞻性单中心试验（UMIN-CTR;识别号：UMIN 000023890）和日本临床试验注册中心（jRCTs 051180143）。
A combination of three post-transplant drugs, cyclophosphamide (PTCy), a calcineurin inhibitor, and mycophenolate mofetil, has long been used for prophylaxis of graft-versus-host-disease (GVHD) after HLA-haploidentical allogeneic hematopoietic cell transplantation (allo-HCT). Recently, this combination has been used following HLA-matched allo-HCT as well, but the optimal combination of drugs for GVHD prophylaxis in an HLA-matched setting remains unclear. This prospective phase II study evaluated the safety and efficacy of PTCy plus tacrolimus (TAC) for GVHD prophylaxis after allo-HCT from HLA-matched related donors (MRD) or HLA-matched unrelated donors (MUD). The cumulative incidences of grades II–IV and III–IV acute GVHD at 100 days post-transplantation were 18% and 5.9%, respectively, in the MRD group, and 18% and 9.1%, respectively, in the MUD group. The cumulative incidences of moderate to severe chronic GVHD at 1 year were 12% and 9.1% in the MRD and MUD groups, respectively. The 1-year overall survival rates in the MRD and MUD groups were 88% and 64%, respectively, and the 1-year GVHD-free, relapse free survival rates were 59% and 50%, respectively. These results suggest that GVHD prophylaxis with a less intensive double drug combination (PT/Cy and TAC) might be feasible after HLA-matched allo-HCT.Clinical Trial NotationThis trial was a prospective single-center trial registered at the University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR; identification number: UMIN000023890) and the Japan Registry of Clinical Trials (jRCTs051180143).
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