Clinical trial NCT06512519: Second Haplo-transplantation for Graft Failure
Official title: A Multicenter Prospective Study of Second Haploidentical Transplantation for Graft Failure After the First Haploidentical Transplantation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Graft Failure
Stem Cell Transplant Complications
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital of Soochow University
name: Ruijin Hospital
name: Zhejiang University
name: First Affiliated Hospital of Xinjiang Medical University
name: Shandong Provincial Hospital
name: Guangdong Provincial Hospital of Traditional Chinese Medicine
name: First Affiliated Hospital of Fujian Medical University
name: Hebei Yanda Ludaopei Hospital
name: Tongji Hospital
name: The First Affiliated Hospital of Zhengzhou University
name: Peking University First Hospital
name: Jiangsu Provincial People's Hospital
name: Shengjing Hospital
name: Xinqiao Hospital of Chongqing
name: Nanfang Hospital, Southern Medical University
name: First Affiliated Hospital of Guangxi Medical University
name: Anhui Provincial Hospital
First posted: 2024-07-22
Enrollment: 34
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 1. Primary disease: hematological malignancies (AML, CML, MDS, lymphoma, etc.); 2. Graft failure after the first haploidentical stem cell transplantation; 3. Time from the first transplantation to the second transplantation is less than 180 days; 4. Age≥14 years.

Exclusion Criteria:

* 1. Active infections; 2. Active GVHD; 3. Organ dysfunction: hepatic injury (Tbil≥2ULN), renal injury (Cr≥1.5ULN), heart injury (EF%\<50% or symptomatic heart failure); 4. Eastern Cooperative Oncology Group (ECOG) score\>2; 5. Expected life time\<30 days; 5. Patients could not cooperate; 6. Other situations that are considered inappropriate for enrollment by the investigators,

Primary outcomes:
measure: Engraftment of neutrophils
timeFrame: 28 days after second transplantation
Secondary outcomes:
measure: Engraftment of Platelet
timeFrame: 100 days after second transplantation
measure: TRM at 28 day
timeFrame: 28 days after second transplantation
measure: TRM at 100 day
timeFrame: 100 days after second transplantation
measure: GVHD
timeFrame: Participants will be followed for an expected average of 1 year
measure: OS
timeFrame: Participants will be followed for an expected average of 1 year
measure: LFS
timeFrame: Participants will be followed for an expected average of 1 year
measure: CIR
timeFrame: Participants will be followed for an expected average of 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
affiliation: Institute of Hematology, Peking University People's Hospital
name: Xiao-Jun Huang, M.D.
role: PRINCIPAL_INVESTIGATOR
References: