Second Haplo-transplantation for Graft Failure

Not Applicable

Recruiting

• Conditions: Graft Failure; Stem Cell Transplant Complications

• Registration Number: NCT06512519
• Lead Sponsor: Peking University People's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-01
• Study First Submitted: 2024-07-16
• Study First Submitted QC: 2024-07-16
• Study First Posted: 2024-07-22
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-05
• Last Update Posted: 2024-11-07
• Primary Completion: 2026-06
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 34

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,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Engraftment of neutrophils	28 days after second transplantation	Engraftment of neutrophils was defined as the first of 3 consecutive days when the absolute neutrophil count achieved 500/uL.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China