ilotinib treatment cessation study
- Conditions
- Chronic Myeloid Leukemia
- Registration Number
- JPRN-jRCT2080222098
- Lead Sponsor
- ovartis Pharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 117
Main Includion criteria
1) ECOG Performance Status of 0, 1, or 2
2) Patient with diagnosis of BCR-ABL positive CML CP
3) Patient has received a minimum of 3 years of tyrosine kinase inhibitor
treatment (first with imatinib (> 4 weeks) and then switched to nilotinib) since initial diagnosis
4) Patient has at least 2 years of nilotinib treatment prior to study entry
5) Patient has achieved MR4.5 during nilotinib treatment, and determined by a Novartis designated central PCR lab assessment at screening
6) Adequate bone marrow and organ function meeting laboratory criteria
Main Exclusion criteria
1) Prior AP, BC or allo-transplant
2) Patient has documented MR4.5 at the time when switched from imatinib to nilotinib
3) Patients with known atypical transcript.
4) CML treatment resistant mutation(s) (T315I, E255K/V, Y253H, F359C/V) detected if testing was done in the past
5) Severe and/or uncontrolled concurrent medical disease
6) History of other active malignancy within 5 years prior to study entry
7) Pregnant or nursing (lactating) women
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>To evaluate the proportion of patients in Treatment-free remission (TFR) within 12 months following nilotinib cessation
- Secondary Outcome Measures
Name Time Method efficacy<br>To evaluate the proportion of patients in TFR, PFS, TFS, OS, To characterize the kinetics of BCRABL transcript after re-start of nilotinib therapy