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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00678275

Enrollment

161

Registered

2008-05-15

Start date

2006-10-31

Completion date

2015-03-31

Last updated

2015-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia

Keywords

Hematopoietic Stem Cell Transplantation

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.

Interventions

DRUGATG FRESENIUS (Anti-Lymphocyte-Globulin)

conditioning regimen with ATG: ATG FRESENIUS dosing: 10mg/kg/day, (day -3, -2,-1) when randomised Arm A

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	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

Measure	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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026