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Sponsors and Collaborators: |
M.D. Anderson Cancer Center Novartis |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00129740 |
The goal of this clinical research study is to learn if an experimental agent, AMN107 (nilotinib), can help to control CML in chronic phase. The safety of this experimental agent will also be studied.
Optional Procedures:
Patients will be asked to have extra blood and/or bone marrow samples taken. These samples will be used to study the effect of the treatment on leukemia cells.
Condition | Intervention | Phase |
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Leukemia, Myelogenous, Chronic |
Drug: Nilotinib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study |
Official Title: | Therapy of Early Chronic Phase Chronic Myelogenous Leukemia (CML) With Oral Nilotinib |
Estimated Enrollment: | 100 |
Study Start Date: | June 2005 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Nilotinib
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Drug: Nilotinib
Nilotinib 400 mg orally twice daily
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Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
New York Heart Association (NYHA) cardiac class 3-4 heart disease as well as impaired cardiac function defined as:
Patients in late chronic phase (i.e., time from diagnosis to treatment >12 months) or blastic phase are excluded. Patients with de novo accelerated phase will be treated but analyzed separately. The definitions of CML phases are as follows:
Accelerated phase CML: presence of any of the following features:
Contact: Hagop M Kantarjian, MD | 713-792-7026 | hkantarj@mdanderson.org |
United States, Texas | |
The University of Texas M.D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Hagop M Kantarjian, MD 713-792-7026 hkantarj@mdanderson.org |
Principal Investigator: | Hagop M Kantarjian, MD | M.D. Anderson Cancer Center |
Responsible Party: | The University of Texas M.D. Anderson Cancer Center ( Hagop Kantarjian M.D./Chair/Professor ) |
Study ID Numbers: | 2005-0048 |
Study First Received: | August 11, 2005 |
Last Updated: | July 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00129740 |
Health Authority: | United States: Food and Drug Administration |
Chronic phase CML Newly diagnosed chronic phase CML AMN107 |
Leukemia Chronic myelogenous leukemia Hematologic Diseases Myeloproliferative Disorders |
Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid, Chronic-Phase Leukemia, Myeloid Bone Marrow Diseases |
Neoplasms Neoplasms by Histologic Type |