NL-OMON42791
Completed
N/A
Immunological monitoring and assessment of biomarkers predictive of clinical response to first-line treatment with bosutinib or imatinib in chronic phase chronic myeloid leukemia - Biomarker substudy for Bfore protocol
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Chronic myeloid leukemia
- Sponsor
- Vrije Universiteit Medisch Centrum
- Enrollment
- 5
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Molecular diagnosis of CP CML of \<\= 6 months (from initial diagnosis).
- •Diagnosis of CP CML with molecular confirmation by detection of BCR\-ABL rearrangement at screening (cytogenetic assessment for Philadelphia chromosome is not required for enrollment); diagnosis of CP CML will be defined as all of the following:
- •a) \<15% blasts in peripheral blood and bone marrow;
- •b) \<30% blasts plus promyelocytes in peripheral blood and bone marrow;
- •c) \<20% basophils in peripheral blood;
- •d) \>\=100 x 109/L platelets (\>\=100,000/mm3\);
- •e) No evidence of extramedullary disease except hepatosplenomegaly; AND
- •f) No prior diagnosis of AP or BP\-CML.
- •Philadelphia chromosome status will be identified at screening. Both Ph\+ and Ph\- patients may be included.
- •2\. Adequate hepatic and renal function defined as:
Exclusion Criteria
- •1\. Any prior medical treatment for CML, including TKIs, with the exception of hydroxyurea and/or anagrelide treatment.
- •2\. Any past or current CNS involvement, including leptomeningeal leukemia.
- •3\. Hypersensitivity to the active substance or to any of the following excipients: microcrystalline cellulose (E460\), croscarmellose sodium (E468\), poloxamer 188, povidone (E1201\), magnesium stearate (E470b), polyvinyl alcohol, titanium dioxide (E171\), macrogol 3350, Talc (E553b), iron oxide red (E172\).
- •4\. Extramedullary disease only.
- •5\. Major surgery or radiotherapy within 14 days of randomization.
- •6\. Concomitant use of or need for medications known to prolong the QT interval.
- •7\. History of clinically significant or uncontrolled cardiac disease
- •8\. Known seropositivity to human immunodeficiency virus (HIV), current acute or chronic hepatitis B (hepatitis B surface\-antigen positive), hepatitis C or evidence of decompensated liver disease or cirrhosis.
- •9\. Recent or ongoing clinically significant GI disorder, e.g. Crohn\*s Disease, Ulcerative Colitis, or prior total or partial gastrectomy.
- •10\. History of another malignancy within 5 years with the exception of basal cell carcinoma or cervical carcinoma in situ or stage 1 or 2 cancer that is considered adequately treated and currently in complete remission for at least l2 months.
Outcomes
Primary Outcomes
Not specified
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