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

Tracking Information

First Received Date ^ICMJE

May 8, 2008

Last Updated Date

April 5, 2009

Start Date ^ICMJE

October 2006

Estimated Primary Completion Date

October 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00678275 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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 ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia

Intervention ^ICMJE

Drug: ATG FRESENIUS (Anti-Lymphocyte-Globulin)
conditioning regimen with ATG: ATG FRESENIUS dosing: 10mg/kg/day, (day -3, -2,-1) when randomised Arm A
Drug: ATG FRESENIUS (Anti-Lymphocyte-Globulin)
conditioning regimen WITHOUT ATG when randomised Arm B

Study Arm (s)

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

Intervention: Drug: ATG FRESENIUS (Anti-Lymphocyte-Globulin)
B
Hematopoeitic Stem Cell Transplantation from HLA-identical sibling, NOT RECEIVING ATG in conditioning regimen

Intervention: Drug: ATG FRESENIUS (Anti-Lymphocyte-Globulin)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

160

Estimated Completion Date

October 2011

Estimated Primary Completion Date

October 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT00678275

Other Study ID Numbers ^ICMJE

ATGFamilyStudy

Has Data Monitoring Committee

Not Provided

Responsible Party

Prof. Dr. N. Kroeger, University Medical Center Hamburg-Eppendorf

Study Sponsor ^ICMJE

Universitätsklinikum Hamburg-Eppendorf

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

Information Provided By

Universitätsklinikum Hamburg-Eppendorf

Verification Date

April 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top