Study of Nilotinib in Ph+ CML-CP Patients With Low Imatinib Trough Plasma Concentrations
Stopped early · Phase 4
Conditions studied: CML, Philadelphia Chromosome Positive (Ph+), Chronic Myelogenous Leukemia Chronic Phase(CML-CP) Patients With Low Imatinib Trough Levels
In brief
This study is to determine the number of European Leukemia Network (ELN)guideline defined treatment failure events from time of study entry in CML-CP patients with low imatinib trough concentrations treated with nilotinib.
Key facts
- Study ID
- NCT01131325
- Run by
- Novartis Pharmaceuticals
- People needed
- 3
- Starts
- 2010-10-21
- Expected to finish
- 2011-05-12
- Last updated by the study team
- 2021-05-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Cytogenetically confirmed Ph+ CML-CP Any prior dose of Imatinib
- Imatinib 400 mg daily for ≥7 consecutive days prior to imatinib trough collection
- Imatinib trough plasma concentration <850 ng/mL
You may not qualify if…
- Prior documented failure events as defined by ELN guidelines:
- Loss of CHR, CCyR, or clonal progression/Ph+
- Less than CHR at 3 months after diagnosis
- No CyR at 6 months after diagnosis
- Less than PCyR at 12 months after diagnosis
- Less than CCyR at 18 months after diagnosis
- Prior accelerated phase or blast phase CML
- Previously documented T315I mutation
- Previous treatment for CML with any other tyrosine kinase inhibitor except for imatinib
- Patients who had any other treatment for CML (transplant) except interferon +/- ara- C, imatinib, hydroxyurea and/or anagrelide
- Impaired cardiac function
- Patients receiving therapy with strong inhibitors of CYP3A4 or medications that prolong the QT interval and cannot be either discontinued or switched to a different medication prior to starting study drug.
- Any other malignancy that is clinically significant or requires active intervention.
- Major surgery within 4 weeks prior to Day 1 of study or who have not recovered from prior surgery
- Treatment with other investigational agents within 30 days of Day 1
- Women who are pregnant, breast feeding, or of childbearing potential without a negative serum test at baseline. Post-menopausal women must be amenorrhoeic for at least 12 months to be considered of non-childbearing potential. Women of childbearing potential must have a negative serum pregnancy test within 7 days of the first dose of nilotinib
- Sexually active male and female patients taking nilotinib unwilling to use adequate contraception throughout the trial and 3 months following discontinuation of study drug
Where it is running
- Comprehensive Cancer Centers of Nevada CCC of Nevada (1) — Las Vegas, Nevada, United States
- Cancer Center of the High Plains — Amarillo, Texas, United States
- Baylor Health Care System/Sammons Cancer Center Dept. of Sammons Cancer (2) — Dallas, Texas, United States
Full record on ClinicalTrials.gov
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