An interventional study of second allogeneic stem cell transplantation in Graft Failure and Stem Cell Transplant Complications, sponsored by Peking University People's Hospital. Recruiting at 1 site in China. Open to participants aged 14 Years and older. Per ClinicalTrials.gov, last updated 2024-11-29.
Sponsored by Peking University People's Hospital · Not applicable, Interventional, and Treatment
Graft failure is a fatal complication following allogeneic stem cell transplantation where a second transplantation is usually required for salvage. We previously reported encouraging results with a novel Flu/Cy regimen. However, there are still around 20% patients developed delayed platelet recovery. We designed a modified regimen to further improve the hematopoietic reconstitution after second transplantation. This prospective, single-arm study aims to investigate the safety and efficacy of this modified regimen.
Peking University People's Hospital is the lead sponsor of 604 studies on the registry; 242 are open to participants now.
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Exclusion Criteria:
second haploidentical stem cell transplantation
Other: second allogeneic stem cell transplantation
1. Change another donor if possible 2. Conditioning regimen: fludarabine (30mg/m2/day, days -6 to -2 )/cyclophosphamide (1g/m2/day, days -5 to -4)/rabbit antithymocyte globulin (1.5mg/kg/day, days -4 to -2) 3. GVHD prophylaxis: cyclosporine A (concentration 150-250ng/ml), mycophenolate mofetil (0.5g bid -3d to neutrophil engraftment)+anti CD25 monoAb (20mg, +1d, +8d, +15d)
Engraftment of neutrophils
Engraftment of neutrophils was defined as the first of 3 consecutive days when the absolute neutrophil count achieved 500/uL.
Time frame: 28 days after second transplantation
Engraftment of Platelet
Platelet engraftment was defined as the first of 7 consecutive days that platelet counts ≥20 × 10\^9/L in the absence of platelet transfusion
Time frame: 100 days after second transplantation
TRM at 28 day
treatment-related mortality(TRM) was defined as death from any cause other than relapse.
Time frame: 28 days after second transplantation
TRM at 100 day
treatment-related mortality (TRM) was defined as death from any cause other than relapse
Time frame: 100 days after second transplantation
GVHD
Both acute and chronic GVHD was diagnosed and graded according to international criteria.
Time frame: Participants will be followed for an expected average of 1 year
OS
Overall survival (OS)
Time frame: Participants will be followed for an expected average of 1 year
LFS
Leukemia-free survival (LFS) was defined as the survival period with continuous CR.
Time frame: Participants will be followed for an expected average of 1 year
CIR
The cumulative incidence of relapse (CIR)
Time frame: Participants will be followed for an expected average of 1 year
Plan to share: No
No publications or documents are linked to this record.
Started Jul 2024 (actual). Primary completion is estimated for Jun 2026, 23 months after the start.
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