Trial to Evaluate the Improvement of Chronic Low-grade AEs in Patients With Ph+ CML With Optimal Response to Imatinib When Switched to Nilotinib
- Conditions
- Philadelphia Positive (Ph+) Chronic Myeloid Leukemia
- Interventions
- Registration Number
- NCT02115386
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
Primary Objective for this study is to evaluate changes in chronic low grade non-hematological adverse events experienced by patients who have been treated with at least 6 months of imatinib and who have not responded to supportive measures, when they are switched to nilotinib (CTCAE grading system).
- Detailed Description
Study was terminated by Novartis
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 7
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Nilotinib Nilotinib Dosage was 300 mg BID daily taken orally without food.
- Primary Outcome Measures
Name Time Method Number of Participants With Improvement of Grades of Persistent Non-hematological Adverse Event (AE) for Grade 1 and 2 at 6 Months at 6 month after switching from imatinib to nilotinib Improvement was defined as decreasing of grade of non-hematological toxicity from 2 to \<2 or from 1 to \<1. In case of multiple low-grade non-hematological toxicities improvement was defined as an improvement of at least one non-hematological AE and no worsening of any other persistent non-hematological AEs.
- Secondary Outcome Measures
Name Time Method Lisiting by Participant of EORTC-QLQ-C30 for Quality of Life Screening, months 1, 3, 6, after switch to nilotinib EORTC-QLQ-C30 was administered to evaluate quality of life changes after switching to nilotinib. Scores ranged from 1 (very poor) to 6 (excellent)
Number of Participants With Improvement of Grades of Persistent Non-hematological Adverse Event (AE) for Grade 1 and 2 at 3 Months at 3 month after switching from imatinib to nilotinib Improvement was defined as decreasing of grade of non-hematological toxicity from 2 to \<2 or from 1 to \<1. In case of multiple low-grade non-hematological toxicities improvement was defined as an improvement of at least one non-hematological AE and no worsening of any other persistent non-hematological AEs.
Number of Participants With Complete Cytogenetic Response (CCyR) at months 6,12 and 24 after switching from imatinib to nilotinib Cytogenetic response will be assessed as the percentage of Ph+ metaphases in the bone marrow and is defined as the following: Complete (CCyR) - 0% Ph+ metaphases.
Number of Participants With a Major Molecular Response Months 1, 3, 6, early termination MMR was defined as a ≥ 3.0 log reduction in BCR-ABL transcripts compared to the standardized baseline or ≤ 0.1 % BCR-ABL/ABL % by international scale as measured by RQ-PCR, confirmed by duplicate analysis of the same sample. Molecular response was described for all time points except screening where response was estimated.
Time to and Duration of CCyR and MMR After Switch From Imatinib to Nilotinib at 24 Months at 24 Months to evaluate time to achievement and duration of CCyR and MMR after switching from imatinib to nilotinib
Time to First Improvement of Persistant Chronic Low-grade Non-hematologic AEs at 24 Months After Switch From Imatinib to Nilotinib first improvement of AEs after switch to 24 Months Evaluate time to first improvement of low-grade non-hematologic adverse events, experienced by patients treated with imatinib and persistent despite of best supportive measures after switching to nilotinib therapy. Optimal improvement is defined as AE grade decreasing to 0.
Trial Locations
- Locations (1)
Novartis Investigative Site
🇷🇺Moscow, Russian Federation