Second Haplo-transplantation for Graft Failure

Not Applicable

Recruiting

• Conditions: Graft Failure; Stem Cell Transplant Complications
• Interventions: Other: second allogeneic stem cell transplantation

• 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

Arm && Interventions

Group	Intervention	Description
intervention arm	second allogeneic stem cell transplantation	second haploidentical stem cell transplantation

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