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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PT-CY-FK +/- ATG | Experimental | GVHD prophylaxis: PT-CY followed by tacrolimus for all patients. low-dose ATG for patients with unrelated or haplo-identical transplantation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PT-CY-FK +/-ATG | Drug | GVHD prophylaxis: PT-CY followed by tacrolimus for all patients. low-dose ATG for patients with unrelated or haplo-identical transplantation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| grade II-IV acute GVHD | cumulated incidence of grade II-IV aGVHD | Day 100 |
| Measure | Description | Time Frame |
|---|---|---|
| grade III-IV acute GVHD | cumulated incidence of grade III-IV aGVHD | Day 100 |
| Non relapse mortality (NRM) | cumulated incidence of NRM |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jiong Hu | Shanghai Jiao Tong University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rui Jin Hospital | Shanghai | Shanghai Municipality | 200025 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33816524 | Derived | Jiang JL, Gao WH, Wang LN, Wan M, Wang L, Hu J. Post-transplantation Cyclophosphamide, Tacrolimus and Low-Dose ATG as GVHD Prophylaxis for Allogeneic Peripheral Stem Cell Transplantation for Adult Patients With Lymphoid Malignancies: A Single Arm Phase II Study. Front Med (Lausanne). 2021 Mar 18;8:630160. doi: 10.3389/fmed.2021.630160. eCollection 2021. |
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| ID | Term |
|---|---|
| D006086 | Graft vs Host Disease |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
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|
| Day 100 |
| chronic GVHD (cGVHD) | cumulated incidence of overall cGVHD | 1 year |
| moderate to sever chronic GVHD | cumulated incidence of moderate to severe cGVHD | 1 year |
| relapse rate | cumulated incidence of bone marrow or PET/biopsy documented relapse | 1 year |
| non relapse mortality | cumulated incidence of NRM | 1 year |
| overall survival | overall survival from entry of study to any cause of death | 1 year |
| GVHD-free relapse free survival (GRFS) | survival without II-IV aGVHD, moderate to severe cGVHD, relapse or any other death event of any case | 1 year |
| D001991 |
| Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |