Second Transplantation for Graft Failure
1 other identifier
interventional
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2018
CompletedFirst Submitted
Initial submission to the registry
September 30, 2018
CompletedFirst Posted
Study publicly available on registry
October 24, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedSeptember 24, 2020
September 1, 2020
2.8 years
September 30, 2018
September 23, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
engraftment
Engraftment of neutrophils was defined as the first of 3 consecutive days when the absolute neutrophil count achieved 500/uL.
28 days after second transplantation
Secondary Outcomes (3)
TRM at 28 day
28 days after second transplantation
TRM at 100d
day 100 after second transplant
Overall survival at 100d
day100 after second transplantation
Study Arms (1)
intervention arm
EXPERIMENTALsecond allogeneic stem cell transplantation
Interventions
1. Change another donor 2. conditioning regimen: FLU/CY/anti-CD25 moAb
Eligibility Criteria
You may qualify if:
- graft failure after first allogeneic stem cell transplantation
- no active infection or GVHD or severe organ dysfunction
- sign written informed consent
You may not qualify if:
- active infection, GVHD, organ failure
- expected life \< 28 days
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking University People's Hospital
Beijing, Beijing Municipality, 100044, China
Related Publications (1)
Sun YQ, Wang Y, Wang FR, Yan CH, Cheng YF, Chen YH, Zhang YY, Han TT, Han W, Suo P, Xu LP, Zhang XH, Liu KY, Huang XJ. Graft Failure in Patients With Hematological Malignancies: A Successful Salvage With a Second Transplantation From a Different Haploidentical Donor. Front Med (Lausanne). 2021 Jun 4;8:604085. doi: 10.3389/fmed.2021.604085. eCollection 2021.
PMID: 34150785DERIVED
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Peking University Institute of Hematology
Study Record Dates
First Submitted
September 30, 2018
First Posted
October 24, 2018
Study Start
March 1, 2018
Primary Completion
December 31, 2020
Study Completion
December 31, 2020
Last Updated
September 24, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will not share