Graft failure is a fatal complication following allogeneic stem cell transplantation where a second transplantation is usually required for salvage. There are no recommended regimens for second transplantations for graft failure, especially in the haploidentical transplant setting. We recently reported encouraging outcomes using a novel method (haploidentical transplantation from a different donor after conditioning with fludarabine and cyclophosphamide). However, the study was performed in single-center and with very small sample size. Therefore, it should be further validated via multicenter study. In this multi-center study, we aim to further evaluate the safety and efficacy of this protocol.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
34
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) 3. GVHD prophylaxis: cyclosporine A (concentration 150-250ng/ml), mycophenolate mofetil (0.5g bid -3d to neutrophil engraftment)+anti CD25 monoAb (20mg -1d, +4d, +15d)
Peking University People's Hospital
Beijing, Beijing Municipality, China
RECRUITINGEngraftment 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
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