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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-002011-24-FI

Enrollment

160

Registered

2008-04-08

Start date

2008-05-22

Completion date

Unknown

Last updated

2015-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myelodysplastic syndromes and secondary acute myeloid leukaemia

Interventions

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Eligibility

Sex/Gender

All

Inclusion criteria

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 =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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 the upper 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.

Design outcomes

Primary

Measure	Time frame
Main Objective: The present study will be a multicenter, prospective phase III-study comparing dose-reduced versus standard conditioning followed by allogeneic stem cell transplantation from related or unrelated donors in patients with MDS or secondary AML.;Secondary Objective: ;Primary end point(s): The hypothesis is that a dose-reduced conditioning will reduce the non-relapse mortality from 40% to 20% at one year after allogeneic stem cell transplantation.	—

Measure

Time frame

Main Objective: The present study will be a multicenter, prospective phase III-study comparing dose-reduced versus standard conditioning followed by allogeneic stem cell transplantation from related or unrelated donors in patients with MDS or secondary AML.;Secondary Objective: ;Primary end point(s): The hypothesis is that a dose-reduced conditioning will reduce the non-relapse mortality from 40% to 20% at one year after allogeneic stem cell transplantation.

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Countries

Belgium, Finland, United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026