Bortezomib and Tipifarnib in MDS.
Recruiting
- Conditions
- Myelodysplastic syndrome, Tipifarnib (ZARNESTRA), Bortezomib (VELCADE).
- Registration Number
- NL-OMON26222
- Lead Sponsor
- Radboud University Nijmegen Medical Centre
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 18
Inclusion Criteria
1. MDS (including the non-proliferative form of CMML, i.e. CMML with a WBC count < 12,0 x 109) /L with < 30% blast cells in the bone marrow and with < 5% circulating blasts);
2. IPSS: Intermediate Risk-2 or High Risk;
Exclusion Criteria
1. IPSS: Low risk and Intermediate-1 category;
2. Candidates for allogeneic stem cell transplantation;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety (type, frequency, and severity [National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0] of adverse events, and relationship of adverse events to VELCADE in combination with ZARNESTRA).
- Secondary Outcome Measures
Name Time Method 1. Erythroid response according to revised IWG criteria (Cheson, 2006);<br /><br>2. Platelet response according to revised IWG criteria;<br /><br>3. Neutrophil response according to revised IWG criteria;<br /><br>4. Marrow response in terms of complete remission, partial remission, stable disease, failure, relapse or disease progression according to revised IWG criteria;<br /><br>5. Cytogenetic response according to revised IWG criteria;<br /><br>6. Duration of hematological (erythroid, platelet and neutrophil), marrow and cytogenetic response and improvement;<br /><br>7. Progression or transformation to leukemia according to FAB classification;<br /><br>8. Time to relapse after complete remission, partial remission, stable disease, failure, relapse, disease progression or AML transformation (according to revised IWG criteria), censored at death;<br /><br>9. Survival.