Second Transplantation for Graft Failure

Stem Cell Transplant Complications Clinical Trial

Official title:

Second Transplantation for Graft Failure After First Allogeneic Stem Cell Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03717545
• Other study ID #: 2nd tx for GF
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: September 2020
• Source: Peking University People's Hospital
• Contact: YUQIAN SUN
• Phone: 861088324577
• Email: sunyuqian83[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Graft Failure
• Stem Cell Transplant Complications

Intervention

Other:
• second allogeneic stem cell transplantation
Change another donor conditioning regimen: FLU/CY/anti-CD25 moAb

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	TRM at 28 day	treatment-related mortality(TRM) was defined as death from any cause other than relapse.	28 days after second transplantation
Secondary	TRM at 100d	treatment-related mortality(TRM) was defined as death from any cause other than relapse.	day 100 after second transplant
Secondary	Overall survival at 100d	Overall survival at 100d	day100 after second transplantation