Prophylaxis of chronic graft-versus-host disease (cGvHD) with or without anti-Tlymphocyte-globulin (ATG Fresenius) prior allogeneic peripheral stem cell transplantantio

• Conditions: Acute lymphoblastic and myeloid leukemia; MedDRA version: 14.1Level: LLTClassification code 10000842Term: Acute lymphatic leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2005-005719-83-ES
• Lead Sponsor: niversitary Hospital Hamburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-15
• Last Update Posted: 28 August 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 160

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 informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 160
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

No complete remission at time of randomization.
Severe irreversible renal, hepatic, pulmonary or cardiac disease, such as:
o Total bilirubin, SGPT or SGOT > 5 times upper the normal level.
o Left ventricular ejection fraction < 30 %.
o Creatinine clearance < 30 ml/min.
o 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

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified