Comparison of Different Dose of Post-transplantation Cyclophosphamide as Graft Versus Host Disease Prophylaxis

NCT06000982 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: PTCY40-50
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 2

Brief Summary

Post-transplantation cyclophosphamide (PTCY) is considered as major graft versus host disease (GVHD) prophylaxis. In our previous study, the investigators demonstrated that the standard dose PTCY of 50mg/kg with tacrolimus and post-engrafted low-dose anti-thymoglobulin (ATG) achieved low incidence of acute GVHD. More recently, it has been shown that reduced dose of PTCY of 40mg/kg is considered with similar efficacy as GVHD prophylaxis, In this study, a multi-center randomized comparison is planned to evaluate the clinical outcome of GVHD prophylaxis of PTCy 40 versus 50.

Conditions

GVHD

Keywords

graft versus host disease (GVHD); post-transplantation cyclophosphamide (PTCy); allogeneic stem cell transplantation; haplo-identical donor

Outcome Measures

Primary Outcomes (1)

• acute GVHD (grade II-IV)

  clinical documentation of grade II-IV aGVHD

  day 100

Secondary Outcomes (5)

• Non-relapse mortality

  1 year

• chronic GVHD

  1 year

• overall survival

  1 year

• Disease-free survival

  1 year

• Survival without relapse and moderate to severe GVHD

  1 year

Study Arms (2)

PTCy-40

EXPERIMENTAL

Patients receive 40mg/kg PTCY (day+3 and +4) with tacrolimus from day+5 and low-dose ATG of 2,5mg/kg 72 hours after documentation neutrophil engraftment.

Drug: PTCY

PTCy-50

ACTIVE COMPARATOR

Patients receive 50mg/kg PTCY (day+3 and +4) with tacrolimus from day+5 and low-dose ATG of 2,5mg/kg 72 hours after documentation neutrophil engraftment.

Drug: PTCY

Interventions

PTCY DRUG

PTCY as 40mg/kg or 50mg/kg at day +3 and +4 for GVHD prophylaxis

PTCy-40; PTCy-50

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with hematological malignancies
• Patients undergo allogeneic stem cell transplantation from haplo-identical donors
• Patents with informed consent provided

You may not qualify if:

• Patients with active infection ()bacteria, fungal or viral)
• Patients with liver, renal and cardiac dysfunction not suitable for undergoing allogeneic stem cell transplantation.

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead
• Shanghai Clinical Research Center: collaborator

Study Sites (2)

Shenzhen People's Hospital

Shenzhen, GaungDong, 518000, China

Location

Rui Jin Hospital

Shanghai, Shanghai Municipality, 200025, China

Location

MeSH Terms

Conditions

Graft vs Host Disease

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• chun Wang

  Zhaxin Hospital, Go Broad Health Care

  STUDY DIRECTOR

Central Study Contacts

chun Wang

CONTACT

8613386259777; wangchunsh@medmail.com.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy director, department of hematology

Study Record Dates

• First Submitted: August 12, 2023
• First Posted: August 21, 2023
• Study Start: October 1, 2023
• Primary Completion: October 1, 2025
• Study Completion: April 1, 2026
• Last Updated: August 21, 2023

Record last verified: 2023-08

Locations

CN (2)