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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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17 August 2015 |
Main ID: |
EUCTR2005-002011-24-BE |
Date of registration:
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10/03/2009 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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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/sAML
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Scientific title:
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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/sAML |
Date of first enrolment:
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08/06/2009 |
Target sample size:
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160 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-002011-24 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
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Phase:
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Countries of recruitment
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Belgium
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Finland
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United Kingdom
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Key inclusion & exclusion criteria
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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.
Age minimum:
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Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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de novo-MDS, treatment-induced MDS (T MDS), AML arising from MDS, treatment-induced AML MedDRA version: 9.1
Level: PT
Classification code 10000880
Term: Acute myeloid leukaemia
MedDRA version: 9.1
Level: LLT
Classification code 10028533
Term: Myelodysplastic syndrome
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Intervention(s)
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Trade Name: Busilvex Product Name: Bulsuphan Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: BUSULFAN CAS Number: 55981 Concentration unit: mg milligram(s)
Trade Name: Fludara Product Name: Fludarabine Pharmaceutical Form: Powder for infusion* INN or Proposed INN: FLUDARABINE CAS Number: 21679141
Trade Name: Cyclophosphamide Product Name: cyclophospamide Product Code: PL 00116/0387 Pharmaceutical Form: Powder for injection* INN or Proposed INN: CYCLOPHOSPHAMIDE CAS Number: 50180
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Primary Outcome(s)
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Main Objective: 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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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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Secondary Objective: •Comparison of haematopoietic recovery by day +30 post transplant between two arms. •Comparison of toxicity of both regimens according to the Bearman-Score •Incidence of acute graft-versus-host disease by day +100 post-transplant acc. to the Glucksberg scale •Incidence of chronic graft-versus-host disease ("limited" or "extensive") by day +365 post-transplant as per to the criteria according to Shulman •Comparison of overall survival post-transplant at two years. •Comparison of event-free survival post-transplant at two years. •Cumulative incidence of relapse post-transplant at two years between both groups. •Comparison of VOD between the two arms •Comparison of incidence of bacterial, viral, fungal and protozoal infection at day 100, at one year and at two years after transplantation.
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Secondary ID(s)
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2005-002011-24-FI
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NCT00682396
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42205525
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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