An Exploratory Trial to Assess the Improvement of Adverse Events in Chronic Myelogenous Leukemia Patients Treated With Imatinib When Switched to Nilotinib Treatment

Completed · Phase 4

Conditions studied: Chronic Myelogenous Leukemia

In brief

The purpose of this exploratory study will be to examine changes in chronic low grade chronic adverse events, measured by Common Terminology Criteria for Adverse Events (CTCAE) grading, when patients are switched from imatinib to nilotinib therapy.

Key facts

Study ID

NCT00980018

Run by

Novartis Pharmaceuticals

People needed

52

Starts

2009-12-01

Expected to finish

2012-12-01

Last updated by the study team

2021-07-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female patients ≥ 18 years of age
• Eastern Cooperative Oncology Group (ECOG) 0, 1, or 2
• Diagnosis of CML-CP associated with Bcr-Abl quantifiable by RQ-PCR (IS)
• Patients must be an imatinib responder and achieved the following efficacy milestones as appropriate for the length of time on imatinib therapy as per protocol
• CML-CP patients initiated on any dose of imatinib
• Ability to provide written informed consent prior to any study related screening procedures being done

You may not qualify if…

• Loss of CHR or cytogenetic response
• Prior accelerated phase or blast phase CML
• Previously documented T315I mutation
• Presence of chromosomal abnormalities (trisomy 8) and/or clonal evolution other than Ph+.
• Previous treatment with any other tyrosine kinase inhibitor except for imatinib.
• Treatment with other investigational agents within 30 days of Day 1.
• History of non-compliance to medical regimens or inability to grant consent.
• Women who are pregnant, breast feeding, or of childbearing potential without a negative serum test at baseline. Male or female patients of childbearing potential unwilling to use contraceptive precautions throughout the trial and 3 months following discontinuation of study drug. Post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Women of childbearing potential must have a negative serum pregnancy test prior to the first dose of nilotinib.
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• Highlands Oncology Group — Fayetteville, Arkansas, United States
• Hematology Oncology Services of Arkansas SC — Little Rock, Arkansas, United States
• USC Norris Cancer Center LAC & USC Medical Center — Los Angeles, California, United States
• Southwest Cancer Care Murrieta — Poway, California, United States
• Rocky Mountain Cancer Centers RMCC - Aurora — Greenwood Village, Colorado, United States
• Florida Cancer Institute — New Port Richey, Florida, United States
• Cancer Centers of Florida PA Cancer Centers of FL-Orlando-4 — Ocoee, Florida, United States
• Stroger Cook County Hospital John H. Stroger Hospital — Chicago, Illinois, United States
• St. Francis Hospital and Health Centers IndianaBlood&MarrowTransplantn — Beech Grove, Indiana, United States
• St. Agnes Hospital — Baltimore, Maryland, United States
• St. Louis University Cancer Center — St Louis, Missouri, United States
• Northwest Cancer Specialists Salmon Creek Office — Portland, Oregon, United States
• Oregon Health Sciences University — Portland, Oregon, United States
• The Jones Clinic — Germantown, Tennessee, United States
• Texas Oncology, P.A. — Bedford, Texas, United States
• Presbyterian Hospital of Dallas TexasOncology@PresbyterianHosp — Dallas, Texas, United States
• Texas Oncology Texas Oncology - Sugar Land — Dallas, Texas, United States
• MD Anderson Cancer Center/University of Texas — Houston, Texas, United States
• Cancer Care Centers of South Texas / HOAST CCC of So. TX- San Antonio(2) — San Antonio, Texas, United States
• Novartis Investigative Site — Brampton, Ontario, Canada
• Novartis Investigative Site — Toronto, Ontario, Canada
• Novartis Investigative Site — Montreal, Quebec, Canada
• Novartis Investigative Site — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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