Clinical trial NCT00678275: Chronic Graft-versus-host Disease (cGvHD) Prophylaxis With or Without ATG Prior to Stem Cell Transplantation (SCT) From HLA-identical Siblings in Patients With Acute Leukemia
Official title: Prophylaxis of Chronic Graft-versus-host Disease (cGvHD) With or Without Anti-T-lymphocyte-globulin (ATG Fresenius) Prior Allogeneic Peripheral Stem Cell Transplantation From HLA-identical Siblings After Myeloablative Conditioning in Patients With Acute Leukemia: A Randomized Phase III-study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Keywords: Hematopoietic Stem Cell Transplantation
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2008-05-15
Enrollment: 161
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This multicenter, prospective phase III-study is to compare the administration of ATG FRESENIUS to the NON-administration of ATG FRESENIUS in a myeloablative conditioning regimen followed by allogeneic hematopoeitic stem cell transplantation from an HLA-identical sibling in patients with acute Leukemia. This clinical trial is to show that the administration of ATG FRESENIUS reduces the risk of chronic Graft-versus-Host disease after allogeneic stem cell transplantation from HLA-identical siblings.


Eligibility criteria: Inclusion Criteria:

* Acute myeloid leukemia in first or subsequent complete remission (de-novo or secondary AML)
* Acute lymphoblastic leukemia in first or subsequent complete remission
* Patient's age: 18 - 65 years
* Myeloablative standard conditioning
* HLA-identical sibling (HLA-A, HLA-B, HLA-DRB1 and HLA-DQB1)
* No major organ dysfunctions
* Patient's written consent

Exclusion Criteria:

* No complete remission at time of randomization
* Severe irreversible renal, hepatic, pulmonary or cardiac disease, such as

  * Total bilirubin, SGPT or SGOT 5 times upper the normal level
  * left ventricular ejection fraction \<30%
  * Creatinine clearance \<30 ml/min
  * DLCO \<35% and/or receiving supplementary continuous oxygen
* Positive serology for HIV
* Pregnant or lactating women
* Serious psychiatric or psychological disorders
* Progressive invasive fungal infection at time of registration

Primary outcomes:
measure: comparison of cumulative incidence of chronic GvHD (limited or extensive) after allogeneic SCT from HLA-identical siblings with or without anti-T-lymphocyte-globulin at 2 years after transplantation
timeFrame: 2 years after transplantation
Secondary outcomes:
measure: comparison of: acute GvHD/quality of life/treatment-related mortality/toxicity/ overall survival/progression-free survival/engraftment/chronic-GvHD-free survival
timeFrame: 2 years after transplantation
measure: incidence of infection/ AEs and ADRs
timeFrame: 2 years after transplantation
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: University Medical Center Hamburg-Eppendorf
Study officials:
affiliation: University Medical Center Hamburg-Eppendorf, Department for Stem Cell Transplantation
name: Nicolaus Kroeger, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bonifazi F, Solano C, Wolschke C, Sessa M, Patriarca F, Zallio F, Nagler A, Selleri C, Risitano AM, Messina G, Bethge W, Herrera P, Sureda A, Carella AM, Cimminiello M, Guidi S, Finke J, Sorasio R, Ferra C, Sierra J, Russo D, Benedetti E, Milone G, Benedetti F, Heinzelmann M, Pastore D, Jurado M, Terruzzi E, Narni F, Volp A, Ayuk F, Ruutu T, Kroger N. Acute GVHD prophylaxis plus ATLG after myeloablative allogeneic haemopoietic peripheral blood stem-cell transplantation from HLA-identical siblings in patients with acute myeloid leukaemia in remission: final results of quality of life and long-term outcome analysis of a phase 3 randomised study. Lancet Haematol. 2019 Feb;6(2):e89-e99. doi: 10.1016/S2352-3026(18)30214-X.
citation: Kroger N, Solano C, Wolschke C, Bandini G, Patriarca F, Pini M, Nagler A, Selleri C, Risitano A, Messina G, Bethge W, Perez de Oteiza J, Duarte R, Carella AM, Cimminiello M, Guidi S, Finke J, Mordini N, Ferra C, Sierra J, Russo D, Petrini M, Milone G, Benedetti F, Heinzelmann M, Pastore D, Jurado M, Terruzzi E, Narni F, Volp A, Ayuk F, Ruutu T, Bonifazi F. Antilymphocyte Globulin for Prevention of Chronic Graft-versus-Host Disease. N Engl J Med. 2016 Jan 7;374(1):43-53. doi: 10.1056/NEJMoa1506002.