A Phase II randomized multicenter study to assess the efficacy of lenalidomide with or without erythropoietin and granulocyte-colony stimulating factor in patients with low and intermediate-1 risk myelodysplastic syndrome.
Completed
- Conditions
- Myelodysplastic syndrome (MDS)
- Registration Number
- NL-OMON20915
- Lead Sponsor
- Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON) P/a HOVON Data CenterErasmus MC - Postbus 2040; 3000 CA Rotterdam; Tel: +31 10 704 1560 Fax: +31 10 704 1028; e-mail: hdc@erasmusmc.nl
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
Inclusion Criteria
1. Patients with MDS classified as:
RA, RARS and RAEB (with <10% myeloid blasts), CMML (with <10% myeloid blasts), according to FAB, or;
Exclusion Criteria
1. Severe cardiac, pulmonary, neurologic, metabolic or psychiatric diseases or active malignancies;
2. Anemia due to other causes than MDS including iron, B12 and folate deficiencies, auto-immune hemolysis and/or paroxysmal noctural hemoglobinuria (PNH);
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Hematological improvement (HI) according to IWG 2006 criteria.
- Secondary Outcome Measures
Name Time Method 1. Adverse events of CTCAE >= grade 2;<br /><br>2. Time-to-HI and duration-of-HI;<br /> <br>3. Number of given treatment cycles per patient, and especially for arm B the number of patients receiving Epo and/or G-CSF;<br /><br>4. Response rate (in terms of CR, PR, including cytogenetic response according to the modified response criteria of the IWG for MDS).<br /><br>5. Progression-free-survival;<br /><br>6. Leukemic evolution. The risk of leukemic evolution will be calculated with competing risk death without previous evolution<br>7. Number of transfusions of red blood cells and duration of RBC transfusion independence.