Prophylaxis of chronic graft-versus-host disease (cGvHD) with or without anti-thymocyte-globulin (ATG) prior allogeneic peripheral stem cell transplantation from HLA-identical siblings after myeloablative conditioning in patients with acute leukemia: a randomized phase III-study - ND

Phase 1

• Conditions: Acute myeloid leukemia in first or subsequent complete remission; MedDRA version: 9.1Level: HLTClassification code 10024291Term: Leukaemias acute myeloid

• Registration Number: EUCTR2005-005719-83-IT
• Lead Sponsor: AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-02-04
• Last Update Posted: 8 October 2021

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
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
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.

Study & Design

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