Post-transplantation Cyclophosphamide for Haploidentical Transplant From Maternal or Collateral Donors

• Sponsor: Peking University People's Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02412423
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arm: 1
• Duration (Months): 24
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

In "beijing model" for haploidentical transplant, the rate of acute graft-versus-host disease (GVHD) from maternal or collateral donors was significantly higher than that from other kins. To reduce the GVHD incidence from maternal or collateral donors, post-transplantation cyclophosphamide is planned to be added into the protocol in "beijing model".

Condition or Disease	Intervention/Treatment	Phase
Hematopoietic Stem Cell Transplantation	Drug: post-transplantation cyclophosphamide	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Study Start Date: Mar 1, 2015
• Actual Primary Completion Date: Aug 1, 2016
• Actual Study Completion Date: Mar 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: treatment group post-transplantation cyclophosphamide	Drug: post-transplantation cyclophosphamide

Outcome Measures

Primary Outcome Measures

1. rate of acute GVHD [participants will be followed for an expected average of 365 days]

Secondary Outcome Measures

1. rate of non-relapse mortality [participants will be followed for an expected average of 365 days]

2. rate of relapse [participants will be followed for an expected average of 365 days]

3. probability of survival [participants will be followed for an expected average of 365 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• haploidentical patients from maternal or collateral donors

Exclusion Criteria:

• uncontrolled infection before transplant

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking University People's Hospital	Beijing		China	100044

Sponsors and Collaborators

• Peking University People's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Xiaojun Huang,MD, director, Peking University People's Hospital
• ClinicalTrials.gov Identifier: NCT02412423
• Other Study ID Numbers: 2015PHB016-01
• First Posted: Apr 9, 2015
• Last Update Posted: Sep 17, 2020
• Last Verified: Sep 1, 2020

• Additional relevant MeSH terms: Cyclophosphamide

Study Results

No Results Posted as of Sep 17, 2020