The myelodysplastic syndrome (MDS) comprises a heterogenous group of hematopoietic stem cell disorders. - quantitative and morphologic abnormalities of bone marrow and peripheral blood cells - chromosomal abnormalities in about half of the cases: deletions , numerical aberrations and balanced translocations similar to those found in acute myeloid leukemia (AML). - DNA hypermethylation, mutations of ras genes, and loss of heterozygosity at tumor suppressor genes. MedDRA version: 8.0 Level: H
Conditions
Interventions
Product Name: Dacogen
Product Code: Decitabine
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: 5-aza-2'-deoxyxytidine=DAC
CAS Number: 2353-33-5
Concentration un
Sponsors
European Organisation for Research and Treatment of Cancer
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Patients aged 60 years and older with either: ? primary MDS without any pretreatment ? primary MDS pretreated with either growth factors, immunosuppressive agents or hydroxyurea. These drugs have to be stopped > 6 weeks before randomisation. ? secondary MDS (previous radio-/chemotherapy for solid tumors or lymphoma) and based on a BM aspiration or, in case of dry tap, on a BM biopsy, with either: ? Bone marrow blast count of 11-20%, ? Bone marrow blast count of = 10% with poor cytogenetics: any numerical or structural abnormality of chromosome 7 and/or complex abnormalities (= 3 abnormalities) ? Bone marrow blast count of 21-30% (AML from MDS according to WHO proposal, RAEB-t according to FAB) in centers not participating in the AML elderly study of the EORTC. For these patients an observation period of one month is necessary to exclude those patients with a rapid progression towards full-blown AML. NB: - The BM sample should be done within 3 weeks prior to randomization, the cytogenetics examination should be done within 8 weeks prior to randomization, the blood sample should be done within 1 week prior to randomization. - Patients for whom the cytogenetic examination was unsuccesful (this means that cytogenetic examination has been performed on BM or on blood material, but that the result was considered as a failure; ex: NN with =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main goal of this open-label randomized phase III trial is to assess the efficacy, toxicity, duration of hospitalization and quality of life of low dose Decitabine versus supportive care in elderly patients with a myelodysplastic syndrome. ;Secondary Objective: As part of the translational research: Unravel the cellular and molecular mechanisms by which the drug is active in MDS, with the long-term aim of improving treatment by defining rational drug combinations and schedules based upon a better understanding of the effect of Decitabine.;Primary end point(s): ? Overall survival | — |
Countries
Czech Republic
Outcome results
None listed