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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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by Universitätsklinikum Hamburg-Eppendorf.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:
NCT00678275
First received: May 8, 2008
Last updated: April 5, 2009
Last verified: April 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
 Drug: ATG FRESENIUS (Anti-Lymphocyte-Globulin)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Universitätsklinikum Hamburg-Eppendorf:

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 [ Time Frame: 2 years after transplantation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • incidence of infection/ AEs and ADRs [ Time Frame: 2 years after transplantation ] [ Designated as safety issue: No ]

Estimated Enrollment: 160
Study Start Date: October 2006
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A
Hematopoeitic Stem Cell Transplantation from HLA-identical sibling, RECEIVING ATG in conditioning regimen
 Drug: ATG FRESENIUS (Anti-Lymphocyte-Globulin)
conditioning regimen with ATG: ATG FRESENIUS dosing: 10mg/kg/day, (day -3, -2,-1) when randomised Arm A
B
Hematopoeitic Stem Cell Transplantation from HLA-identical sibling, NOT RECEIVING ATG in conditioning regimen
 Drug: ATG FRESENIUS (Anti-Lymphocyte-Globulin)
conditioning regimen WITHOUT ATG when randomised Arm B

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00678275

Contacts
Contact: Nicolaus Kroeger, Prof. Dr. +49-40-42803-5864 nkroeger@uke.uni-hamburg.de
Contact: Marion Heinzelmann, R.N. +49-40-42803-4188 mheinzel@uke.uni-hamburg.de

Locations
Germany
University Medical Center Hamburg-Eppendorf Recruiting
Hamburg, Germany, 20246
Contact: Nicolaus Kroeger, Prof. Dr.     +49-40-42803-5684     nkroeger@uke.uni-hamburg.de    
Contact: Marion Heinzelmann, R.N.     +49-40-42803-4188     mheinzel@uke.uni-hamburg.de    
Principal Investigator: Nicolaus Kroeger, Prof. Dr.            
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
  More Information

No publications provided

Responsible Party: Prof. Dr. N. Kroeger, University Medical Center Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT00678275     History of Changes
Other Study ID Numbers: ATGFamilyStudy
Study First Received: May 8, 2008
Last Updated: April 5, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Germany: Paul-Ehrlich-Institut

Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
Hematopoietic Stem Cell Transplantation

Additional relevant MeSH terms:
Graft vs Host Disease
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Immune System Diseases
Neoplasms by Histologic Type
Neoplasms
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Antilymphocyte Serum
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013