Dose-reduced versus standard conditioning followed by allogeneic stem cell transplantation in patients with MDS or sAML: A randomised phase III study (RICMAC) - RICMAC MDS/sAM

• Conditions: de novo-MDS, treatment-induced MDS (T MDS), AML arising from MDS, treatment-induced AML; MedDRA version: 9.1Level: PTClassification code 10000880Term: Acute myeloid leukaemia; MedDRA version: 9.1Level: LLTClassification code 10028533Term: Myelodysplastic syndrome

• Registration Number: EUCTR2005-002011-24-BE
• Lead Sponsor: European Group for Blood and Marrow Transplantation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-10
• Last Update Posted: 17 August 2015

Recruitment & Eligibility

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

Inclusion Criteria

•Disease: Cytologically proven
•primary or therapy-related myelodysplastic syndrome (MDS), either as
?refractory anaemia (RA) according FAB or RA with or without dysplasia according WHO,
?refractory anaemia with ringsideroblasts (RARS) according FAB or RARS with or without dysplasia according WHO,
?refractory anaemia with excess of blasts (RAEB) according FAB or RAEB I or RAEB II according WHO,
?refractory anaemia with excess of blast in transformation (RAEB T) according FAB,
?CMML (dysplastic type) according WHO,
•or secondary acute myeloid leukaemia (sAML).
•Blast count < 20 percent in bone marrow with or without chemotherapy at time of transplantation.
•Patient eligible for standard and dose-reduced conditioning as per local guideline.
•Patient age 18 – 60 years if donor is a HLA-matched unrelated donor (HLA-A, HLA-B, HLA-DRB1 and HLA-DQB1) (one mismatch allowed):
•Patient age 18 – 65 years if donor is a HLA-matched related donor ((HLA-A, HLA-B, HLA-DRB1 and HLA-DQB1) (one antigen-mismatch allowed):
•No major organ dysfunction.
•Written informed consent of the patient.

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

•Blasts > 20 % in bone marrow at time of transplantation
•No written informed consent.
•Central nervous involvement.
•Severe irreversible renal, hepatic, pulmonary or cardiac disease, such as
•Total bilirubin, SGPT or SGOT > 2 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.
•Patients with a life-expectancy of less than six months because of another debilitating disease.
•Serious psychiatric or psychological disorders.
•Invasive fungal infection at time of registration.

Study & Design

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