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Spots Global Cancer Trial Database for An Extension Study to Determine the Safety and Anti-Leukemic Effects of Imatinib Mesylate in Adult Participants With Ph+ Leukemia

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Trial Identification

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

Study Description

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:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Novartis Pharmaceuticals

Affiliation: Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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