Status:
COMPLETED
CMR Rate of Newly Diagnosed CML-CP Patients Treated With Nilotinib
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Chronic Myelogenous Leukemia in Chronic Phase
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
"This is a single-arm, open-label, multi-center study of complete molecular response (CMR) in adult patients with newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia in...
Eligibility Criteria
Inclusion
- Patients with Ph+ CML-CP within 3 months of diagnosis. Male or female patients' ≥ 18 years of age. Patients must have adequate end organ function.
Exclusion
- Previously documented T315I mutation. Other CML treatment is an exclusion criteria with the following exception: While awaiting study start, patients may be treated with anagrelide (no treatment duration limit), hydroxyurea (no treatment duration limit), and/or up to a 14 day supply of a tyrosine kinase inhibitor (TKI) approved by the FDA for frontline treatment. Patients taking a TKI prior to study entry must have at least a one day washout from their last dose of medication and have recovered from any side effects of such therapy.
- Impaired cardiac function as defined by the protocol. Patients with contraindications to receiving nilotinib, including concomitant medications.
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT01227577
Start Date
November 1 2010
End Date
November 1 2014
Last Update
February 8 2016
Active Locations (32)
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1
Pacific Cancer Medical Center, Inc.
Anaheim, California, United States, 92801
2
Providence St. Joseph Medical Center Roy&Patricia Disney Fam Cancer
Burbank, California, United States, 91505-6866
3
Bay Area Cancer Research Dept.ofBayAreaCancerResearch
Concord, California, United States, 94520
4
St. Jude Heritage Medical Group Virginia Crosson Cancer Center
Yorba Linda, California, United States, 92886