Study of Nilotinib in Ph+ CML-CP Patients With Low Imatinib Trough Plasma Concentrations
Information source: Novartis
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: CML; Philadelphia Chromosome Positive (Ph+); Chronic Myelogenous Leukemia Chronic Phase(CML-CP) Patients With Low Imatinib Trough Levels
Intervention: nilotinib (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Novartis
Summary
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.
Clinical Details
Official title: A Multi-center, Single Arm Study of Nilotinib in Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) Patients With Low Imatinib Trough Plasma Concentrations
Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: To determine the number of ELN-guideline defined treatment failure events from time of study entry in CML-CP patients with low imatinib trough concentrations (<850 ng/mL) treated with nilotinib.
Secondary outcome: To determine the proportion of ELN-defined optimal responses on nilotinib.To determine the rate and time to loss of CCyR, MMR and CMR on nilotinib. To determine the time to and duration of the CCyR, MMR and CMR achieved on nilotinib. To determine EFS, PFS and OS with up to 2 years of nilotinib treatment and overall safety profile
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Ph+ CML-CP within 12 months of diagnosis
- Imatinib 400 mg qd for up to 12 months
- Imatinib trough plasma concentration <850 ng/mL
- Patient that have met response milestones including:
1. CHR and at least minor CyR (Ph+ ≤65%) at 3 months from diagnosis
2. At least pCyR at 6 months from diagnosis (Ph+ ≤35%)
3. CCyR at 12 months from diagnosis
Exclusion Criteria:
- Prior documented failure events including:
- Loss of CHR or CCyR
- Less than CHR (stable disease or disease progression) at 3 months after diagnosis
- No CyR at 6 months after diagnosis
- Less than PCyR at 12 months after diagnosis
- Prior accelerated phase or blast phase CML
- Previously documented T315I mutation
- Previous treatment with any other tyrosine kinase inhibitor except for imatinib.
- Patients who had any other treatment for CML (transplant) except imatinib,
hydroxyurea and/or anagrelide
- Impaired cardiac function (refer to Section 5. 2 for details)
- 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.
Locations and Contacts
University of chicago, Chicago, Illinois 60637, United States; Recruiting
H. Weiner, Phone: 773-702-2084
Richard larson, M.D., Principal Investigator
Indiana Blood and Marrow Transplantation, LLC, Beech Grove, Indiana 46107, United States; Recruiting
Elissa Knezevich, Phone: 317-782-7296, Email: eknezevich@ibmtindy.com
Luke Akard, M.D., Principal Investigator
The Jones Clinic, Germantown, Tennessee 38138, United States; Recruiting
Lori J. Lynch, Phone: 901-685-5969, Ext: 322, Email: llynch@jonescancerclinic.com
C. Michael Jones, M.D., Principal Investigator
Additional Information
Starting date: March 2010
Last updated: May 25, 2010
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