Status:
COMPLETED
A Study Investigating the Predictive Value of Philadelphia Positive Stem Cell Properties in Newly Diagnosed Patients With Chronic Myeloid Leukemia in Chronic Phase Receiving Treatment With Imatinib
Lead Sponsor:
University of British Columbia
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Chronic Myeloid Leukemia
Eligibility:
All Genders
18+ years
Brief Summary
Imatinib (IM) is first-line treatment for patients with newly diagnosed CML in chronic phase. The drug is associated with high rates of cytogenetic responses with minimal toxicity in approximately 80%...
Eligibility Criteria
Inclusion
- Diagnosis of CML in chronic phase.
- ECOG \<2.
- Normal organ function and ULN Total bili, AST and ALT.
- Must have the ability to understand and sign a written consent form
Exclusion
- Patients may not be receiving any other investigational agents.
- May not have prior treatment with Imatinib, Dasatinib, Nilotinib or other tyrosine kinase inhibitors.
- Patients must not have uncontrolled intercurrent illness including, but not limited to, ongoing or active infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmias, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant or nursing mothers
- Patients must have no prior malignancies except for; adequately treated non-melanoma skin cancer, cervical carcinoma-in-situ, adequately treated Stage I or II cancer from which the patient is in complete remission, or any other cancer from which the patient has been disease free for 5 years
Key Trial Info
Start Date :
October 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 31 2020
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT01215487
Start Date
October 1 2010
End Date
May 31 2020
Last Update
April 30 2021
Active Locations (1)
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1
Leukemia BMT program of BC, Vancouver General Hospital, Hematology Research and Clinical Trials Unit
Vancouver, British Columbia, Canada, V5Z 1M9