PT-CY With or Without Low-dose ATG for Lymphoid Malignancies Undergoing Allo-HSCT

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Post Transplantation Cyclophosphamide With or Without Low-dose ATG for Patients With Lymphoid Malignancies Undergoing Allogeneic Stem Cell Transplantation

Conditions
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GVHD, Acute

Intervention / Treatment
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* Drug: PT-CY-FK +/-ATG


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PT-CY-FK +/- ATG<br>GVHD prophylaxis: PT-CY followed by tacrolimus for all patients. low-dose ATG for patients with unrelated or haplo-identical transplantation. | Drug: PT-CY-FK +/-ATG<br>* GVHD prophylaxis: PT-CY followed by tacrolimus for all patients. low-dose ATG for patients with unrelated or haplo-identical transplantation.<br>* Other names: RJH-Lym-2018;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| grade II-IV acute GVHD | cumulated incidence of grade II-IV aGVHD | Day 100 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aGVHD, cGVHD, PT-CY