ilotinib plus pegylated interferon alpha2b in CML.
Completed
- Conditions
- CML in chronic phasesuboptimal response or stable detectable molecular response after at least 2 years of imatinib treatment
- Registration Number
- NL-OMON29139
- Lead Sponsor
- VU University Medical Center, Amsterdam
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
1. Patients at least 18 years of age;
2. At diagnosis chronic myeloid leukemia in chronic phase;
Exclusion Criteria
1. Prior accelerated phase or blast crisis;
2. Patient has received another investigational agent within last 6 months;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. The proportion of patients with confirmed MR4.0 IS at Month 12;<br /><br>The predictive value for response of:<br>2. Relative and absolute numbers of CD4+ and CD8+ T cells, NK cells, NKT cells, B cells and regulatory T cells (CD4+, CD25+, FoxP3+), as measured by flow cytometry assay pre- and post-treatment;<br /><br>3. The presence and frequency of BCR-ABL-, WT1, Prame- or PR1-specific cytotoxic T-cells as measured by flow cytometry using tetramer technique;<br /><br>4. The cytotoxic capacity of lymphocytes, as measured by killing activity of NK cells, IFN ã production by and granzyme B staining of T cells after stimulation, all performed pre- and post treatment;<br /><br>5. Plasma cytokine profiles, as measured by the Luminex multiplex array system pre- and post-treatment;<br /><br>6. Phosphoproteomic profiles pre- and post-treatment;<br /><br>7. The frequency of residual leukemic stem cells, as detected by flow cytometry using phospho-CRKL activity as a read-out of BCR-ABL activity.
- Secondary Outcome Measures
Name Time Method 1. Safety and tolerability, including frequency and type of AEs/serious AEs;<br /><br>2. The proportion of patients with MR4.0 and with MR4.5 IS at or by Month 3, 6, 12, 18 and 24;<br /><br>3. The proportion of patients who complete the planned 9 months of combination therapy with PegIFN (i.e. to Month 12 assessment);<br /><br>4. The rate of loss of CCyR, MMR and MR4.0 at Month 12, 18;<br /><br>5. The proportion of patients progressing to advanced disease phase;<br /><br>6. Overall survival;<br /><br>7. Quality of Life as assessed by standard questionaires;<br /><br>8. ECOG performance rating at baseline, month 3, 6, 12 and 18.