Modified Second Haplo-transplantation for Graft Failure

Not Applicable

Recruiting

• Conditions: Stem Cell Transplant Complications; Graft Failure

• Registration Number: NCT06512545
• 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. We previously reported encouraging results with a novel Flu/Cy regimen. However, there are still around 20% patients developed delayed platelet recovery. We designed a modified regimen to further improve the hematopoietic reconstitution after second transplantation. This prospective, single-arm study aims to investigate the safety and efficacy of this modified regimen.

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: 2024-11-26
• Last Update Posted: 2024-11-28
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• 1.Primary disease: hematological malignancies(AML, CML, MDS, lymphoma, etc.); 2.Graft failure after first allogeneic 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
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
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.
OS	Participants will be followed for an expected average of 1 year	Overall survival (OS)
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.
CIR	Participants will be followed for an expected average of 1 year	The cumulative incidence of relapse (CIR)
TRM at 28 day	28 days after second transplantation	treatment-related mortality(TRM) was defined as death from any cause other than relapse.
TRM at 100 day	100 days after second transplantation	treatment-related mortality (TRM) was defined as death from any cause other than relapse

Trial Locations

Locations (1)

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