Featured Clinical Trial:
Chronic Myelogenous Leukemia (product/compound: nilotinib)
ClinicAid Locations: Southern California – Fountain Valley, Corona, Riverside
Status:
Open for enrollment (accepting patients). Please contact us and mention Trial ID NCT01227577.
Condition: Chronic Myelogenous Leukemia in Chronic Phase
Product Name/Compound: nilotinib
Full Study Title: 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 Chronic Phase (CML-CP)
Study 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 chronic phase (CML-CP). The study is designed to evaluate early and deep molecular responses up to 4 years on nilotinib treatment. The primary end point is Rate of confirmed CMR in newly diagnosed Philadelphia chromosome positive CML-CP patients.
Eligible Participants:
Inclusion (Eligible):
- Male or female patients >= 18 years of age.
- Patients with Ph+ CML-CP within 3 months of diagnosis.
- Patients must have adequate end organ function.
Exclusion (Not Eligible):
- 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.
Study Phase: Phase IV (What are Phases?)
To receive information and updates for this trial:
Please contact us and mention the Trial ID below.
Trial ID (ClinicalTrials.gov): NCT01227577
<< Back to all ClinicAid clinical trials
