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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00678275
First Posted: May 15, 2008
Last Update Posted: May 13, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf
  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
Intervention Model: Parallel Assignment
Masking: None (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:


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 ]

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 ]
  • incidence of infection/ AEs and ADRs [ Time Frame: 2 years after transplantation ]

Enrollment: 161
Study Start Date: October 2006
Study Completion Date: March 2015
Primary Completion Date: February 2014 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00678275


Locations
Germany
University Medical Center Hamburg-Eppendorf
Hamburg, Germany, 20246
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Investigators
Principal Investigator: Nicolaus Kroeger, Prof. Dr. University Medical Center Hamburg-Eppendorf, Department for Stem Cell Transplantation
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT00678275     History of Changes
Other Study ID Numbers: ATGFamilyStudy
First Submitted: May 8, 2008
First Posted: May 15, 2008
Last Update Posted: May 13, 2015
Last Verified: May 2015

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

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