Second Haplo-transplantation for Graft Failure
NCT Number: NCT06512519
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Graft Failure|Stem Cell Transplant Complications
Interventions: OTHER: second allogeneic stem cell transplantation
Sponsor: Peking University People's Hospital
Collaborators: The First Affiliated Hospital of Soochow University|Ruijin Hospital|Zhejiang University|First Affiliated Hospital of Xinjiang Medical University|Shandong Provincial Hospital|Guangdong Provincial Hospital of Traditional Chinese Medicine|First Affiliated Hospital of Fujian Medical University|Hebei Yanda Ludaopei Hospital|Tongji Hospital|The First Affiliated Hospital of Zhengzhou University|Peking University First Hospital|Jiangsu Provincial People's Hospital|Shengjing Hospital|Xinqiao Hospital of Chongqing|Nanfang Hospital, Southern Medical University|First Affiliated Hospital of Guangxi Medical University|Anhui Provincial Hospital
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 34
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2027-06
Locations: Peking University People's Hospital, Beijing, Beijing, 100044, China

Summary:
Graft failure is a fatal complication following allogeneic stem cell transplantation where a second transplantation is usually required for salvage. There are no recommended regimens for second transplantations for graft failure, especially in the haploidentical transplant setting. We recently reported encouraging outcomes using a novel method (haploidentical transplantation from a different donor after conditioning with fludarabine and cyclophosphamide). However, the study was performed in single-center and with very small sample size. Therefore, it should be further validated via multicenter study. In this multi-center study, we aim to further evaluate the safety and efficacy of this protocol.

Primary Outcome Measures: Engraftment of neutrophils, Engraftment of neutrophils was defined as the first of 3 consecutive days when the absolute neutrophil count achieved 500/uL., 28 days after second transplantation
Secondary Outcome Measures: Engraftment of Platelet, Platelet engraftment was defined as the first of 7 consecutive days that platelet counts ≥20 × 10\^9/L in the absence of platelet transfusion, 100 days after second transplantation|TRM at 28 day, treatment-related mortality (TRM) was defined as death from any cause other than relapse, 28 days after second transplantation|TRM at 100 day, treatment-related mortality (TRM) was defined as death from any cause other than relapse, 100 days after second transplantation|GVHD, Both acute and chronic GVHD was diagnosed and graded according to international criteria., Participants will be followed for an expected average of 1 year|OS, Overall survival (OS), Participants will be followed for an expected average of 1 year|LFS, Leukemia-free survival (LFS) was defined as the survival period with continuous CR., Participants will be followed for an expected average of 1 year|CIR, The cumulative incidence of relapse (CIR), Participants will be followed for an expected average of 1 year