Lead Investigator: Yanguang Cao
Title of Proposal Research: Identifying Prognostic and Predictive Factors for Causal Exposure-Response Analysis of Imatinib in Treatment of Chronic Myeloid Leukemia
Vivli Data Request: 10204
Funding Source: None
Potential Conflicts of Interest: None
Summary of the Proposed Research:
Finding the right dosage of cancer medication is crucial for effective treatment. In clinical trials, we study how different doses of a drug affect patients to decide the best amount to use. However, it’s not always easy to see the true effects because patients respond differently to treatment. To understand these effects better, we need to identify other factors that influence patient health and treatment outcomes. These factors can include things like age, overall health, and specific characteristics of the cancer. In our study, we are focusing on a drug called imatinib, used to treat a type of blood cancer called chronic myeloid leukemia (CML). CML is a cancer of the blood and bone marrow that arises from the abnormal growth of blood cells, primarily affecting the white blood cells. It is characterized by the presence of the Philadelphia chromosome, which leads to the production of an abnormal protein that promotes the uncontrolled growth of these cells. Patients with CML often experience symptoms such as fatigue, night sweats, and an increased risk of infections due to the elevated white blood cell counts. We want to understand how different doses of imatinib affect patient outcomes and identify key factors that influence their response to the treatment. We will use advanced data analysis techniques to discover these important factors and clarify how they impact the relationship between the drug dosage and patient health. This will help us make better-informed decisions about the optimal dose of imatinib for treating CML.
Requested Studies:
A PHASE 3 RANDOMIZED, OPEN-LABEL STUDY OF BOSUTINIB VERSUS IMATINIB IN SUBJECTS WITH NEWLY DIAGNOSED CHRONIC PHASE PHILADELPHIA CHROMOSOME POSITIVE CHRONIC MYELOGENOUS LEUKEMIA
Data Contributor: Pfizer Inc.
Study ID: NCT00574873
Sponsor ID: 3160A4-3000
A Phase 3 Randomized, Open-Label Study of Ponatinib Versus Imatinib in Adult Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase
Data Contributor: Takeda
Study ID: NCT01650805
Sponsor ID: AP24534-12-301