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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

Primary Purpose

Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
ATG FRESENIUS (Anti-Lymphocyte-Globulin)
ATG FRESENIUS (Anti-Lymphocyte-Globulin)
Sponsored by
Universitätsklinikum Hamburg-Eppendorf
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring Hematopoietic Stem Cell Transplantation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Medical Center Hamburg-Eppendorf

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

A

B

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

comparison of: acute GvHD/quality of life/treatment-related mortality/toxicity/ overall survival/progression-free survival/engraftment/chronic-GvHD-free survival
incidence of infection/ AEs and ADRs

Full Information

First Posted
May 8, 2008
Last Updated
May 12, 2015
Sponsor
Universitätsklinikum Hamburg-Eppendorf
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1. Study Identification

Unique Protocol Identification Number
NCT00678275
Brief Title
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

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitätsklinikum Hamburg-Eppendorf

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia
Keywords
Hematopoietic Stem Cell Transplantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
161 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Other
Arm Description
Hematopoeitic Stem Cell Transplantation from HLA-identical sibling, RECEIVING ATG in conditioning regimen
Arm Title
B
Arm Type
Other
Arm Description
Hematopoeitic Stem Cell Transplantation from HLA-identical sibling, NOT RECEIVING ATG in conditioning regimen
Intervention Type
Drug
Intervention Name(s)
ATG FRESENIUS (Anti-Lymphocyte-Globulin)
Intervention Description
conditioning regimen with ATG: ATG FRESENIUS dosing: 10mg/kg/day, (day -3, -2,-1) when randomised Arm A
Intervention Type
Drug
Intervention Name(s)
ATG FRESENIUS (Anti-Lymphocyte-Globulin)
Intervention Description
conditioning regimen WITHOUT ATG when randomised Arm B
Primary Outcome Measure Information:
Title
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
Time Frame
2 years after transplantation
Secondary Outcome Measure Information:
Title
comparison of: acute GvHD/quality of life/treatment-related mortality/toxicity/ overall survival/progression-free survival/engraftment/chronic-GvHD-free survival
Time Frame
2 years after transplantation
Title
incidence of infection/ AEs and ADRs
Time Frame
2 years after transplantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolaus Kroeger, Prof. Dr.
Organizational Affiliation
University Medical Center Hamburg-Eppendorf, Department for Stem Cell Transplantation
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
30709437
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. Erratum In: Lancet Haematol. 2019 Mar;6(3):e121.
Results Reference
derived
PubMed Identifier
26735993
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.
Results Reference
derived

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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

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