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

NCT00678275 | Completed Phase 3

• 1 other identifier: ATGFamilyStudy
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myeloid Leukemia; Acute Lymphoblastic Leukemia

Keywords

Hematopoietic Stem Cell Transplantation

Outcome Measures

Primary Outcomes (1)

• 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

  2 years after transplantation

Secondary Outcomes (2)

• comparison of: acute GvHD/quality of life/treatment-related mortality/toxicity/ overall survival/progression-free survival/engraftment/chronic-GvHD-free survival

  2 years after transplantation

• incidence of infection/ AEs and ADRs

  2 years after transplantation

Study Arms (2)

A

OTHER

Hematopoeitic Stem Cell Transplantation from HLA-identical sibling, RECEIVING ATG in conditioning regimen

Drug: ATG FRESENIUS (Anti-Lymphocyte-Globulin)

B

OTHER

Hematopoeitic Stem Cell Transplantation from HLA-identical sibling, NOT RECEIVING ATG in conditioning regimen

Drug: ATG FRESENIUS (Anti-Lymphocyte-Globulin)

Interventions

ATG FRESENIUS (Anti-Lymphocyte-Globulin) DRUG

conditioning regimen with ATG: ATG FRESENIUS dosing: 10mg/kg/day, (day -3, -2,-1) when randomised Arm A

A

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

University Medical Center Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Related Publications (3)

• Chakupurakal G, Freudenberger P, Skoetz N, Ahr H, Theurich S. Polyclonal anti-thymocyte globulins for the prophylaxis of graft-versus-host disease after allogeneic stem cell or bone marrow transplantation in adults. Cochrane Database Syst Rev. 2023 Jun 21;6(6):CD009159. doi: 10.1002/14651858.CD009159.pub3.

  PMID: 37341189 DERIVED

• 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.

  PMID: 30709437 DERIVED

• 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.

  PMID: 26735993 DERIVED

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Nicolaus Kroeger, Prof. Dr.

  University Medical Center Hamburg-Eppendorf, Department for Stem Cell Transplantation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2008
• First Posted: May 15, 2008
• Study Start: October 1, 2006
• Primary Completion: February 1, 2014
• Study Completion: March 1, 2015
• Last Updated: May 13, 2015

Record last verified: 2015-05

Locations

DE (1)