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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia

Intervention / Treatment
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* Drug: ATG FRESENIUS (Anti-Lymphocyte-Globulin)
* Drug: ATG FRESENIUS (Anti-Lymphocyte-Globulin)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: A<br>Hematopoeitic Stem Cell Transplantation from HLA-identical sibling, RECEIVING ATG in conditioning regimen | Drug: ATG FRESENIUS (Anti-Lymphocyte-Globulin)<br>* conditioning regimen with ATG: ATG FRESENIUS dosing: 10mg/kg/day, (day -3, -2,-1) when randomised Arm A<br>|
| Other: B<br>Hematopoeitic Stem Cell Transplantation from HLA-identical sibling, NOT RECEIVING ATG in conditioning regimen | Drug: ATG FRESENIUS (Anti-Lymphocyte-Globulin)<br>* conditioning regimen WITHOUT ATG when randomised Arm B<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| incidence of infection/ AEs and ADRs |  | 2 years after transplantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hematopoietic Stem Cell Transplantation