Clinical Trial: Prophylaxis Roles of IL-2 Treatment on Acute GVHD After Transplantation
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Prophylaxis Roles of Low Dose of IL-2 Treatment on Acute GVHD After Haploidentical Transplantation
Brief Summary: The effects of haploidentical rhG-CSF-mobilized unmanipulated blood and marrow transplantation (HBMT) on hematological malignancies are well established.The aim of this prospective cohort trial is to determine if acute graft-versus-host disease (aGVHD) could be decreased with IL2 therapy post HBMT.
Detailed Summary: The effects of haploidentical rhG-CSF-mobilized unmanipulated blood and marrow transplantation (HBMT) on hematological malignancies are well established.The aim of this prospective cohort trial is to determine if acute graft-versus-host disease (aGVHD) could be decreased with IL2 therapy post HBMT.low dose of IL-2 (40 million U/m2) will be administered from WBC engraftment to day 90 post haploidentical transplantation. IL-2 will be administered three times a week.
Sponsor: Peking University People's Hospital
Current Primary Outcome: II-IV acute graft-versus-host disease (aGVHD)post transplantation [ Time Frame: Day 100 post transplantation ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Severe chronic GVHD post transplantation [ Time Frame: 1 year ]
- CMV infection post transplantation [ Time Frame: Day 100 post transplantation ]
- Measureable residual disease (MRD)-positive test post transplantation [ Time Frame: 1 year ]
- Hematological relapse post transplantation [ Time Frame: 1 year ]
- Disease-free free survival post transplantation [ Time Frame: 1 year ]
- Overall survival post transplantation [ Time Frame: 1 year ]
Original Secondary Outcome: Same as current
Information By: Peking University People's Hospital
Dates:
Date Received: January 8, 2016
Date Started: March 2016
Date Completion: December 2017
Last Updated: November 28, 2016
Last Verified: November 2016
