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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

161 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2015-03-31

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.

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Detailed Description

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Conditions

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Acute Myeloid Leukemia Acute Lymphoblastic Leukemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

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

Group Type OTHER

ATG FRESENIUS (Anti-Lymphocyte-Globulin)

Intervention Type DRUG

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

B

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

Group Type OTHER

ATG FRESENIUS (Anti-Lymphocyte-Globulin)

Intervention Type DRUG

conditioning regimen WITHOUT ATG when randomised Arm B

Interventions

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ATG FRESENIUS (Anti-Lymphocyte-Globulin)

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

Intervention Type DRUG

ATG FRESENIUS (Anti-Lymphocyte-Globulin)

conditioning regimen WITHOUT ATG when randomised Arm B

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No