GVHD, Acute
Conditions
Keywords
aGVHD, cGVHD, PT-CY
Brief summary
All patients received Flu-BU-VP16 as myeloablative conditioning followed by cyclophosphamide (D+3 and +4) and subsequent tacrolimus. For patients with unrelated or haplo-donor received low-dose ATG at Day +15.
Detailed description
For patients with high-risk lymphoid malignancies, patients will undergo allo-HSCT from HLA matched sibling, unrelated (9\ 10/10) donor or hallo-identical donors. For all patients will receive myeloablative conditioning with 5-day fludarabine, 2-day VP-16 and 3-day busulifan. For prophylaxis graft versus host disease (GVHD), patients will receive cyclophosphamide 50mg/kg daily on D+3 and +4 with subsequent tacrolimus starting at D+5. For patients receiving HSCT from unrelated or haplo-donor, low-dose ATG 2.5mg/kg will be given on Day +15.
Interventions
DRUGPT-CY-FK +/-ATG
GVHD prophylaxis: PT-CY followed by tacrolimus for all patients. low-dose ATG for patients with unrelated or haplo-identical transplantation.
Sponsors
Shanghai Jiao Tong University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* patients with lymphoid malignancies: CR1 or CR2 for acute lymphoblastic leukemia; T cell lymphoma (any CR/PR); B cell lymphoma (PR1 or CR2), hodgkin's disease (CR2 or beyond), Sezary syndrome * patients with HLA matched sibling, unrelated (HLA 9\ 10/10 matched) or haplo-identical donor
Exclusion criteria
* patients with active infection * patients with abnormal liver function damage: ALT/AST above 2X normal range * patients with abnormal renal function damage Scr\>160µmol/L; * patients with insufficient pulmonary function (FEV1，FVC，DLCO\<50%）and heart failure or with EF \<50%) * patients with mental instability * unwilling to give inform consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| grade II-IV acute GVHD | Day 100 | cumulated incidence of grade II-IV aGVHD |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Non relapse mortality (NRM) | Day 100 | cumulated incidence of NRM |
| chronic GVHD (cGVHD) | 1 year | cumulated incidence of overall cGVHD |
| moderate to sever chronic GVHD | 1 year | cumulated incidence of moderate to severe cGVHD |
| grade III-IV acute GVHD | Day 100 | cumulated incidence of grade III-IV aGVHD |
| non relapse mortality | 1 year | cumulated incidence of NRM |
| overall survival | 1 year | overall survival from entry of study to any cause of death |
| GVHD-free relapse free survival (GRFS) | 1 year | survival without II-IV aGVHD, moderate to severe cGVHD, relapse or any other death event of any case |
| relapse rate | 1 year | cumulated incidence of bone marrow or PET/biopsy documented relapse |
Countries
China
Outcome results
None listed