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Second Transplantation for Graft Failure

Second Transplantation for Graft Failure After First Allogeneic Stem Cell Transplantation

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03717545
Enrollment
12
Registered
2018-10-24
Start date
2018-03-01
Completion date
2020-12-31
Last updated
2020-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Graft Failure, Stem Cell Transplant Complications

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.

Interventions

1. Change another donor 2. conditioning regimen: FLU/CY/anti-CD25 moAb

Sponsors

Peking University People's Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
engraftment28 days after second transplantationEngraftment of neutrophils was defined as the first of 3 consecutive days when the absolute neutrophil count achieved 500/uL.

Secondary

MeasureTime frameDescription
TRM at 28 day28 days after second transplantationtreatment-related mortality(TRM) was defined as death from any cause other than relapse.
TRM at 100dday 100 after second transplanttreatment-related mortality(TRM) was defined as death from any cause other than relapse.
Overall survival at 100dday100 after second transplantationOverall survival at 100d

Countries

China

Contacts

Primary ContactYUQIAN SUN
sunyuqian83@hotmail.com861088324577

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026