Rui Jin Hospital
Shanghai, Shanghai Municipality, 200025, China
NCT Number: NCT04118075
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.
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Notify Me16 year–60 year
All sexes
Interventional
Phase 2
Shanghai, Shanghai Municipality, 200025, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
GVHD prophylaxis: PT-CY followed by tacrolimus for all patients. low-dose ATG for patients with unrelated or haplo-identical transplantation.
Other names: RJH-Lym-2018
Time frame: Day 100
cumulated incidence of grade II-IV aGVHD
Time frame: Day 100
cumulated incidence of grade III-IV aGVHD
Time frame: Day 100
cumulated incidence of NRM
Time frame: 1 year
cumulated incidence of overall cGVHD
Time frame: 1 year
cumulated incidence of moderate to severe cGVHD
Time frame: 1 year
cumulated incidence of bone marrow or PET/biopsy documented relapse
Time frame: 1 year
cumulated incidence of NRM
Time frame: 1 year
overall survival from entry of study to any cause of death
Time frame: 1 year
survival without II-IV aGVHD, moderate to severe cGVHD, relapse or any other death event of any case
Shanghai Jiao Tong University School of Medicine
Other
Post Transplantation Cyclophosphamide With or Without Low-dose ATG for Patients With Lymphoid Malignancies Undergoing Allogeneic Stem Cell Transplantation
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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