ClinicalTrials.gov
ClinicalTrials.gov Menu

Haplo SCT vs Haplo-cord SCT for Patients With Hematological Disorders

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03719534
Recruitment Status : Recruiting
First Posted : October 25, 2018
Last Update Posted : October 25, 2018
Sponsor:
Information provided by (Responsible Party):
The First Affiliated Hospital of Soochow University

Brief Summary:
Patients who have hematological disorders and will undergo haplo-identical donor stem cell transplantation (haplo SCT) are candidates of this trial. Participants will randomized into two arms: Arm A will undergo a typical haplo SCT, while Arm B will receive an co-infusion of an unrelated cord blood unit (haplo-cord SCT) in addition to Arm A. Overall survival, progression-free survival, nonrelapse mortality and cumulative incidence of relapse will be recorded and endpoints.

Condition or disease Intervention/treatment Phase
Hematopoietic Stem Cell Transplantation Haplo-identical Donor Cord Blood Hematologic Diseases Procedure: haplo-SCT Procedure: haplo-cord SCT Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Haplo-identical Stem Cell Transplantation Versus Haplo-cord Stem Cell Transplantation for Patients With Hematological Disorders
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Disorders

Arm Intervention/treatment
Active Comparator: Haplo-SCT
people enrolled in this arm will receive a typical haplo-identical donor SCT
Procedure: haplo-SCT
SCT will be performed with a haplo-identical donor

Experimental: Haplo-cord SCT
people enrolled in this arm will receive a co-infusion of cord blood unit in addition to a typical haplo-identical donor SCT
Procedure: haplo-cord SCT
Haplo-identical donor SCT will be performed with co-infusion of unrelated cord blood unit




Primary Outcome Measures :
  1. Overall survival from SCT [ Time Frame: 3 year post-SCT ]
    estimated overall survival at 3 year post-SCT


Secondary Outcome Measures :
  1. Progression-free survival from SCT [ Time Frame: 3 year post-SCT ]
    estimated progression-free survival at 3 year post-SCT

  2. Cumulative incidence of non-relapse mortality from SCT [ Time Frame: 3 year post-SCT ]
    estimated nonrelapse mortality at 3 year post-SCT

  3. Cumulative incidence of relapse from SCT [ Time Frame: 3 year post-SCT ]
    estimated cumulative incidence of nonrelapse mortality at 3 year post-SCT



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with hematological disorders and preparing to perform allogeneic stem cell transplantation;
  • Have no available HLA matched donor;
  • A haplo-identical donor is available for stem cell collection;
  • An unrelated cord blood unit is available with at least 4/6 matched HLA loci;
  • ECOG 0-3;
  • Could understand the written inform consent.

Exclusion Criteria:

  • contraindication of stem cell transplantation;
  • uncontrolled active infection;
  • sever organ dysfunction (heart, lung, liver, kidney, etc.);
  • participating other trials with same purpose
  • refuse to sign written inform consent;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03719534


Contacts
Contact: Jia Chen, M.D., Ph.D. +86 512 67781856 chenjiasuzhou@gmail.com

Locations
China, Jiangsu
The First Affiliated Hospital of Soochow University Recruiting
Suzhou, Jiangsu, China, 215006
Contact: Jia Chen, M.D.    +86 512 6778 1856    chenjiasuzhou@gmail.com   
Sponsors and Collaborators
The First Affiliated Hospital of Soochow University

Responsible Party: The First Affiliated Hospital of Soochow University
ClinicalTrials.gov Identifier: NCT03719534     History of Changes
Other Study ID Numbers: SZ3703
First Posted: October 25, 2018    Key Record Dates
Last Update Posted: October 25, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hematologic Diseases