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Sponsored by: |
Irish Clinical Oncology Research Group |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00809211 |
RATIONALE: Nilotinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well nilotinib works in treating patients with newly diagnosed chronic phase chronic myelogenous leukemia.
Condition | Intervention | Phase |
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Leukemia |
Drug: nilotinib Procedure: cytogenetic analysis Procedure: mutation analysis Procedure: pharmacological study Procedure: polymerase chain reaction |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label |
Official Title: | A Phase II Multi-Center, Open-Label, Study of Nilotinib at a Dose of 300mg Twice Daily in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) |
Estimated Enrollment: | 40 |
Study Start Date: | October 2008 |
Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive oral nilotinib twice daily on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
Peripheral blood and bone marrow samples are collected periodically for mutation analysis, Bcr-Abl analysis by quantitative PCR, metaphase cytogenetics, and pharmacokinetic analysis.
After completion of study therapy, patients are followed every 3 months for 2 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Cytogenetically confirmed chronic myelogenous leukemia (CML) by standard conventional cytogenetic analysis of bone marrow*
In chronic phase, as defined by the following:
Philadelphia chromosome-positive disease as demonstrated by (9;22) translocation (presence of Bcr-Abl)
PATIENT CHARACTERISTICS:
No impaired cardiac function including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
United States, Texas | |
M. D. Anderson Cancer Center at University of Texas | Recruiting |
Houston, Texas, United States, 77030-4009 | |
Contact: Clinical Trials Office - M. D. Anderson Cancer Center at the U 713-792-3245 | |
Ireland | |
University College Hospital | Recruiting |
Galway, Ireland | |
Contact: Mike O'Dwyer, MD 353-91-524-222 | |
United Kingdom, Northern Ireland | |
Centre for Cancer Research and Cell Biology at Queen's University Belfast | Recruiting |
Belfast, Northern Ireland, United Kingdom, BT9 7BL | |
Contact: Mary F. McMullin, MD 44-28-9097-2960 |
Principal Investigator: | Mike O'Dwyer, MD | University College London Hospitals |
Study ID Numbers: | CDR0000629801, ICORG-08-02, EUDRACT-2008-004551-30, EU-20899 |
Study First Received: | December 16, 2008 |
Last Updated: | January 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00809211 |
Health Authority: | Unspecified |
Philadelphia chromosome positive chronic myelogenous leukemia chronic phase chronic myelogenous leukemia |
Chromosomal abnormalities Philadelphia Chromosome Leukemia Chronic myelogenous leukemia Hematologic Diseases Myeloproliferative Disorders |
Chromosome Aberrations Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid, Chronic-Phase Leukemia, Myeloid Bone Marrow Diseases |
Neoplasms Pathologic Processes Neoplasms by Histologic Type Translocation, Genetic |