Second Haplo-transplantation for Graft Failure

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.

Conditions

• Graft Failure
• Stem Cell Transplant Complications

Interventions

OTHER

second allogeneic stem cell transplantation

1. Change another donor if possible 2. Conditioning regimen: fludarabine (30mg/m2/day, days -6 to -2 ), cyclophosphamide (1g/m2/day, days -5 to -4) 3. GVHD prophylaxis: cyclosporine A (concentration 150-250ng/ml), mycophenolate mofetil (0.5g bid -3d to neutrophil engraftment)+anti CD25 monoAb (20mg -1d, +4d, +15d)

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University

  collaborator OTHER

• Ruijin Hospital

  collaborator OTHER

• Zhejiang University

  collaborator OTHER

• First Affiliated Hospital of Xinjiang Medical University

  collaborator OTHER

• Shandong Provincial Hospital

  collaborator OTHER_GOV

• Guangdong Provincial Hospital of Traditional Chinese Medicine

  collaborator OTHER

• First Affiliated Hospital of Fujian Medical University

  collaborator OTHER

• Hebei Yanda Ludaopei Hospital

  collaborator OTHER

• Tongji Hospital

  collaborator OTHER

• The First Affiliated Hospital of Zhengzhou University

  collaborator OTHER

• Peking University First Hospital

  collaborator OTHER

• Jiangsu Provincial People's Hospital

  collaborator OTHER

• Shengjing Hospital

  collaborator OTHER

• Xinqiao Hospital of Chongqing

  collaborator OTHER

• Nanfang Hospital, Southern Medical University

  collaborator OTHER

• First Affiliated Hospital of Guangxi Medical University

  collaborator OTHER

• Anhui Provincial Hospital

  collaborator OTHER_GOV

• Peking University People's Hospital

  lead OTHER

Principal Investigators

• Xiao-Jun Huang, M.D. · Institute of Hematology, Peking University People's Hospital

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

14 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-07-01

Primary Completion

2026-06-30

Completion

2027-06-30

Countries

• China

Study Locations