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Unrelated Umbilical Cord Blood Following HLA-haploidentical Hematopoietic Stem Cell Transplantation in Patients With β-thalassemia Major

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02126046
Recruitment Status : Unknown
Verified April 2015 by Chunfu Li, Nanfang Hospital of Southern Medical University.
Recruitment status was:  Recruiting
First Posted : April 29, 2014
Last Update Posted : April 16, 2015
Sponsor:
Information provided by (Responsible Party):
Chunfu Li, Nanfang Hospital of Southern Medical University

Tracking Information
First Submitted Date  ICMJE April 18, 2014
First Posted Date  ICMJE April 29, 2014
Last Update Posted Date April 16, 2015
Study Start Date  ICMJE September 2012
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 27, 2014)
  • overall survival（OS） [ Time Frame: 12 months ]
    the measure is a composite
  • TM-free survival（TFS） [ Time Frame: 12 months ]
    the measure is a composite
  • Transplant Related Martality (TRM) [ Time Frame: 12 months ]
    the measure is a composite
  • Primary or Secondary Graft Rejection (GR) [ Time Frame: 12 months ]
    the measure is a composite
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 27, 2014)
  • The cumulative incidences of acute graft-versus-host disease（GVHD） [ Time Frame: 12 months ]
    the measure is a composite
  • The cumulative incidences of chronic graft vesus host disease (cGVHD) [ Time Frame: 12 months ]
    the measure is a composite
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Unrelated Umbilical Cord Blood Following HLA-haploidentical Hematopoietic Stem Cell Transplantation in Patients With β-thalassemia Major
Official Title  ICMJE Not Provided
Brief Summary Allo-hematopoietic stem cell transplantation(HSCT) is the only way to cure β-thalassemia major at present. To expand donor pool，we developed a haplo-identical HSCT (Hi-HSCT) platform. But in prior Hi-HSCT using high dose post-transplant Cyclophosphamide in patients with leukemia, cytopenia post-transplant often developed, which was considered as a symptom of GVHD. Therefore, the investigators add unrelated umbilical cord blood (UCB) to the Hi-HSCT. It has reported that, as third-party cells, UCB will reduce GVHD.The purpose of this study is to determine whether unrelated UCB following Hi-HSCT can improve outcomes of Hi-HSCT in patients with β-thalassemia major.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Thalassemia Major
Intervention  ICMJE Genetic: unrelated CB following haplo-identical hematopoietic stem cells transplantation
Study Arms  ICMJE Hi-HSC-CBT
Intervention: Genetic: unrelated CB following haplo-identical hematopoietic stem cells transplantation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 27, 2014)		 30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2016
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • β-thalassemia major
  • < 18 year old
  • Unrelated umbilical cord blood following Haplo-identical HSCT

Exclusion Criteria:

  • ≥ 18 year old
  • HLA- matched related donors
  • Unrelated donor transplants
  • Unrelated umbilical cord blood transplants
  • Severe iron overload in heart by T2*
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Months to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02126046
Other Study ID Numbers  ICMJE NFTM20130101
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Chunfu Li, Nanfang Hospital of Southern Medical University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Nanfang Hospital of Southern Medical University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Nanfang Hospital of Southern Medical University
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP