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Second Transplantation for Graft Failure

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: NCT03717545
Recruitment Status : Recruiting
First Posted : October 24, 2018
Last Update Posted : February 20, 2020
Sponsor:
Information provided by (Responsible Party):
Xiaojun Huang,MD, Peking University People's Hospital

Brief Summary:
Graft failure is a lethal complication after allogeneic stem cell transplantation, which often need a salvage transplantation. However, the current outcome of second transplantation for graft failure is far from satisfactory. We performed a prospective single-arm study to investigate the safety and efficacy of a novel regimen.

Condition or disease Intervention/treatment Phase
Graft Failure Stem Cell Transplant Complications Other: second allogeneic stem cell transplantation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Second Transplantation for Graft Failure After First Allogeneic Stem Cell Transplantation
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : February 29, 2020
Estimated Study Completion Date : March 30, 2020

Arm Intervention/treatment
Experimental: intervention arm
second allogeneic stem cell transplantation
Other: second allogeneic stem cell transplantation
  1. Change another donor
  2. conditioning regimen: FLU/CY/anti-CD25 moAb




Primary Outcome Measures :
  1. engraftment [ Time Frame: 28 days after second transplantation ]
    Engraftment of neutrophils was defined as the first of 3 consecutive days when the absolute neutrophil count achieved 500/uL.


Secondary Outcome Measures :
  1. TRM at 28 day [ Time Frame: 28 days after second transplantation ]
    treatment-related mortality(TRM) was defined as death from any cause other than relapse.

  2. TRM at 100d [ Time Frame: day 100 after second transplant ]
    treatment-related mortality(TRM) was defined as death from any cause other than relapse.

  3. Overall survival at 100d [ Time Frame: day100 after second transplantation ]
    Overall survival at 100d



Information from the National Library of Medicine

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

Inclusion Criteria:

  • graft failure after first allogeneic stem cell transplantation
  • no active infection or GVHD or severe organ dysfunction
  • sign written informed consent

Exclusion Criteria:

  • active infection, GVHD, organ failure
  • expected life < 28 days

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): NCT03717545


Contacts
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Contact: YUQIAN SUN 861088324577 sunyuqian83@hotmail.com

Locations
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China, Beijing
Peking University People's Hospital Recruiting
Beijing, Beijing, China, 100044
Contact: YUQIAN SUN    861088324577    sunyuqian83@hotmail.com   
Sponsors and Collaborators
Peking University People's Hospital

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Responsible Party: Xiaojun Huang,MD, Head of Peking University Institute of Hematology, Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT03717545    
Other Study ID Numbers: 2nd tx for GF
First Posted: October 24, 2018    Key Record Dates
Last Update Posted: February 20, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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