aGVHD Clinical Trial
Official title:
Prospective Study of Combined ATG Regimen for Prophylaxis of aGVHD in Matched Sibling Donor PBSCT
NCT number | NCT02677181 |
Other study ID # | 81370666 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | January 2016 |
Est. completion date | April 2022 |
Verified date | May 2022 |
Source | Chinese PLA General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine the efficacy and safety of combined ATG (antithymocyte globulin ) regimen for aGVHD(acute graft-versus-host disease ) prophylaxis in matched sibling donor peripheral blood stem cell transplantation (MSD-PBSCT).
Status | Completed |
Enrollment | 100 |
Est. completion date | April 2022 |
Est. primary completion date | January 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 70 Years |
Eligibility | Inclusion Criteria: 1. acute myeloid leukemia (AML) in CR1 (complete remission 1) or CR2 (complete remission 2) phase regardless of cytogenetics; 2. CML CP(chronic myelogenous leukemia , chronic phase); NHL (non-Hodgkin's lymphoma ) 3. MDS-RAEB(myelodysplastic syndrome -refractory anemia with excess blasts ). 4. All patients should aged 40 to 70 years 5. Have matched sibling donor. 6. Patients without any uncontrolled infections or without severe pulmonary, renal, hepatic or cardiac diseases . Exclusion Criteria: 1. Patients aged less than 40 years old ; 2. Patients with any uncontrolled infections or with severe pulmonary, renal, hepatic or cardiac diseases; 3. AML patients with t (15;17); |
Country | Name | City | State |
---|---|---|---|
China | Liping Dou | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Chinese PLA General Hospital | 309th Hospital of Chinese People's Liberation Army, Beijing Naval General Hospital, Space Center Hospital, Peking University |
China,
Armand P, Kim HT, Zhang MJ, Perez WS, Dal Cin PS, Klumpp TR, Waller EK, Litzow MR, Liesveld JL, Lazarus HM, Artz AS, Gupta V, Savani BN, McCarthy PL, Cahn JY, Schouten HC, Finke J, Ball ED, Aljurf MD, Cutler CS, Rowe JM, Antin JH, Isola LM, Di Bartolomeo P, Camitta BM, Miller AM, Cairo MS, Stockerl-Goldstein K, Sierra J, Savoie ML, Halter J, Stiff PJ, Nabhan C, Jakubowski AA, Bunjes DW, Petersdorf EW, Devine SM, Maziarz RT, Bornhauser M, Lewis VA, Marks DI, Bredeson CN, Soiffer RJ, Weisdorf DJ. Classifying cytogenetics in patients with acute myelogenous leukemia in complete remission undergoing allogeneic transplantation: a Center for International Blood and Marrow Transplant Research study. Biol Blood Marrow Transplant. 2012 Feb;18(2):280-8. doi: 10.1016/j.bbmt.2011.07.024. Epub 2011 Jul 31. — View Citation
Finke J, Bethge WA, Schmoor C, Ottinger HD, Stelljes M, Zander AR, Volin L, Ruutu T, Heim DA, Schwerdtfeger R, Kolbe K, Mayer J, Maertens JA, Linkesch W, Holler E, Koza V, Bornhäuser M, Einsele H, Kolb HJ, Bertz H, Egger M, Grishina O, Socié G; ATG-Fresenius Trial Group. Standard graft-versus-host disease prophylaxis with or without anti-T-cell globulin in haematopoietic cell transplantation from matched unrelated donors: a randomised, open-label, multicentre phase 3 trial. Lancet Oncol. 2009 Sep;10(9):855-64. doi: 10.1016/S1470-2045(09)70225-6. Epub 2009 Aug 18. — View Citation
Hamadani M, Blum W, Phillips G, Elder P, Andritsos L, Hofmeister C, O'Donnell L, Klisovic R, Penza S, Garzon R, Krugh D, Lin T, Bechtel T, Benson DM, Byrd JC, Marcucci G, Devine SM. Improved nonrelapse mortality and infection rate with lower dose of antithymocyte globulin in patients undergoing reduced-intensity conditioning allogeneic transplantation for hematologic malignancies. Biol Blood Marrow Transplant. 2009 Nov;15(11):1422-30. doi: 10.1016/j.bbmt.2009.07.006. Epub 2009 Sep 1. — View Citation
Rezvani AR, Storb RF. Prevention of graft-vs.-host disease. Expert Opin Pharmacother. 2012 Aug;13(12):1737-50. doi: 10.1517/14656566.2012.703652. Epub 2012 Jul 7. Review. — View Citation
Storb R, Deeg HJ, Whitehead J, Appelbaum F, Beatty P, Bensinger W, Buckner CD, Clift R, Doney K, Farewell V, et al. Methotrexate and cyclosporine compared with cyclosporine alone for prophylaxis of acute graft versus host disease after marrow transplantation for leukemia. N Engl J Med. 1986 Mar 20;314(12):729-35. — View Citation
Storek J, Mohty M, Boelens JJ. Rabbit anti-T cell globulin in allogeneic hematopoietic cell transplantation. Biol Blood Marrow Transplant. 2015 Jun;21(6):959-70. doi: 10.1016/j.bbmt.2014.11.676. Epub 2014 Dec 5. Review. — View Citation
Wang Y, Fu HX, Liu DH, Xu LP, Zhang XH, Chang YJ, Chen YH, Wang FR, Sun YQ, Tang FF, Liu KY, Huang XJ. Influence of two different doses of antithymocyte globulin in patients with standard-risk disease following haploidentical transplantation: a randomized trial. Bone Marrow Transplant. 2014 Mar;49(3):426-33. doi: 10.1038/bmt.2013.191. Epub 2013 Dec 2. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants with cGVHD as assessed by chronic graft versus host disease grading criteria (refer to NIH criteria) | Chronic graft versus host disease grading criteria (refer to NIH criteria) | three years | |
Secondary | all cause mortality | two years | ||
Secondary | Number of participants relapse as assessed by NCCN (National Comprehensive Cancer Network )criteria | two years | ||
Secondary | DFS(disease-free survival ) | disease-free survival | two years | |
Secondary | TRM(treatment-related mortality ) | treatment-related mortality | two years | |
Secondary | Number of participants with aGVHD as assessed by acute graft versus host disease grading criteria (refer to Glucksberg criteria) | three months |
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