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

Universitätsklinikum Hamburg-Eppendorf

Status and phase: Completed; Phase 3

Conditions: Acute Lymphoblastic Leukemia; Acute Myeloid Leukemia

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

Study type: Interventional

Funder types: Other

Identifiers

NCT00678275

ATGFamilyStudy

Details and patient eligibility

About

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.

Enrollment: 161 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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161 participants in 2 patient groups

A

Other group

Description:

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

Treatment:

Drug: ATG FRESENIUS (Anti-Lymphocyte-Globulin)

Drug: ATG FRESENIUS (Anti-Lymphocyte-Globulin)

B

Other group

Description:

Hematopoeitic Stem Cell Transplantation from HLA-identical sibling, NOT RECEIVING ATG in conditioning regimen

Treatment:

Drug: ATG FRESENIUS (Anti-Lymphocyte-Globulin)

Drug: ATG FRESENIUS (Anti-Lymphocyte-Globulin)