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Brief Title: An Extension Study to Determine the Safety and Anti-Leukemic Effects of Imatinib Mesylate in Adult Participants With Ph+ Leukemia
Official Title: An Extension to a Phase II Study to Determine the Safety and Anti-Leukemic Effects of STI571 in Adult Patients With Philadelphia Chromosome Positive Leukemia Including Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, and Accelerated Phase Chronic Myeloid Leukemia
Study ID: NCT00171249
Brief Summary: The objectives of Part 1 of the study were: * To determine the rate of hematologic response (HR) lasting ≥4 weeks in participants with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in the accelerated phase (AP). * To evaluate duration of HR, overall survival, cytogenetic response (CyR), time to blast crisis in CML participants in the AP, improvement of symptomatic parameters, tolerability and safety of STI571 treatment. The objective of the extension (Part 2) was: -To enable participants to have access to study drug and continue study treatment and to decrease data collection to include only overall survival and serious adverse events.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Dana Faber Cancer Institute, Boston, Massachusetts, United States
New York Presbyterian Hospital, New York, New York, United States
Oregon Health & Sciences University, Portland, Oregon, United States
MD Anderson Cancer Center, University of Texas, Houston, Texas, United States
Novartis Investigative Site, Pessac, , France
Novartis Investigative Site, Poitiers, , France
Novartis Investigative Site, Frankfurt, , Germany
Novartis Investigative Site, Leipzig, , Germany
Novartis Investigative Site, Mainz, , Germany
Novartis Investigative Site, Mannheim, , Germany
Novartis Investigative Site, Monza, , Italy
Novartis Investigative Site, London, , United Kingdom
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR