Second Haplo-transplantation for Graft Failure

A Multicenter Prospective Study of Second Haploidentical Transplantation for Graft Failure After the First Haploidentical Transplantation

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.

Study Overview

• Status: Recruiting
• Conditions: Graft Failure; Stem Cell Transplant Complications
• Intervention / Treatment: Other: second allogeneic stem cell transplantation

• Study Type: Interventional
• Enrollment (Estimated): 34
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yu-qian Sun, M.D.; Phone Number: +86-10-88324577; Email: sunyuqian83@hotmail.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100044
      • Recruiting
      • Peking University People's Hospital
      • Contact: Yu-qian Sun, M.D.; Phone Number: +86-10-88324577; Email: sunyuqian83@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intervention arm; second haploidentical stem cell transplantation	Other: second allogeneic stem cell transplantation; Change another donor if possible; Conditioning regimen: fludarabine (30mg/m2/day, days -6 to -2 ), cyclophosphamide (1g/m2/day, days -5 to -4); GVHD prophylaxis: cyclosporine A (concentration 150-250ng/ml), mycophenolate mofetil (0.5g bid -3d to neutrophil engraftment)+anti CD25 monoAb (20mg -1d, +4d, +15d)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Peking University People's Hospital
• Collaborators: Peking University First Hospital; Guangdong Provincial Hospital of Traditional Chinese Medicine; Tongji Hospital; First Affiliated Hospital of Fujian Medical University; Shengjing Hospital; Ruijin Hospital; Shandong Provincial Hospital; The First Affiliated Hospital of Soochow University; The First Affiliated Hospital of Zhengzhou University; Zhejiang University; Xinqiao Hospital of Chongqing; Hebei Yanda Ludaopei Hospital; First Affiliated Hospital of Xinjiang Medical University; Anhui Provincial Hospital; Jiangsu Provincial People's Hospital; First Affiliated Hospital of Guangxi Medical University; Nanfang Hospital, Southern Medical University
• Investigators: Principal Investigator: Xiao-Jun Huang, M.D., Institute of Hematology, Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: July 16, 2024
• First Submitted That Met QC Criteria: July 16, 2024
• First Posted (Actual): July 22, 2024

Study Record Updates

• Last Update Posted (Estimated): November 7, 2024
• Last Update Submitted That Met QC Criteria: November 5, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2024PHB181-001M

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No