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

Acute Myeloid Leukemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00678275
• Other study ID #: ATGFamilyStudy
• Status: Completed
• Phase: Phase 3
• First received: May 8, 2008
• Last updated: May 12, 2015
• Start date: October 2006
• Est. completion date: March 2015

Study information

• Verified date: May 2015
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-Institut
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 161
• Est. completion date: March 2015
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Acute Myeloid Leukemia
• Graft vs Host Disease
• Leukemia
• Leukemia, Lymphoid
• Leukemia, Myeloid, Acute
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

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

Locations

Country	Name	City	State
Germany	University Medical Center Hamburg-Eppendorf	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	incidence of infection/ AEs and ADRs		2 years after transplantation	No