Second Transplantation for Graft Failure

Not Applicable

• Conditions: Stem Cell Transplant Complications; Graft Failure

• Registration Number: NCT03717545
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-01
• Study First Submitted: 2018-09-30
• Study First Submitted QC: 2018-10-22
• Study First Posted: 2018-10-24
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-23
• Last Update Posted: 2020-09-24
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
engraftment	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

Name	Time	Method
TRM at 28 day	28 days after second transplantation	treatment-related mortality(TRM) was defined as death from any cause other than relapse.
Overall survival at 100d	day100 after second transplantation	Overall survival at 100d
TRM at 100d	day 100 after second transplant	treatment-related mortality(TRM) was defined as death from any cause other than relapse.

Trial Locations

Locations (1)

Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China