Clinical Trial DRUG CA180406
- Open-Label Single Arm Phase 2 Study Evaluating Dasatinib Therapy Discontinuation In Patients With Chronic Phase Chronic Myeloid Leukemia (CP-CML) With Stable Complete Molecular Response (CMR) DASFREE
- Principal Investigator
- Jessica Altman
- Status: COMPLETED
- Study Type: Therapeutic, Treatment
- Protocol No:.DRUG CA180406
- The purpose of this study is to evaluate dasatinib treatment discontinuation among patients who have achieved a sustained stable complete molecular response (CMR) for 12 months or longer.
- Chronic myeloid leukemia (CML) is a cancer of the white blood cells. It is a form of leukemia. Approximately 85% of patients with CML are in the chronic phase at the time of diagnosis. During this phase, patients are usually asymptomatic or have only mild symptoms of fatigue, left side pain, joint and/or hip pain, or abdominal fullness. The duration of chronic phase is variable and depends on how early the disease was diagnosed as well as the therapies used. Dasatinib (SPRYCEL® ) has been studied in a number of CML subjects and has been approved in approximately 69 countries (including by the United States Food and Drug Administration (FDA) and the European Commission) for the treatment of adults with CML with resistance or intolerance to prior therapy including imatinib. For the treatment of adult patients with newly diagnosed chronic phase CML, SPRYCEL is approved in the US and Europe. Marketing authorization approval for the indication of adult patients with newly diagnosed CP-CML is currently under review in several other countries. Patients with chronic phase CML who have achieved a CMR after dasatinib or other tyrosine kinase inhibitor (TKI) therapy often ask whether it is still necessary for their treatment to continue, and that question has been the focus of some recent research.
Some of the eligibility criteria include:
- Participants must be diagnosed with chronic phase CML, on treatment with dasatinib for at least 2 years and in dasatinib-induced complete molecular remission for at least 1 year prior to study entry.
- Participants must be 18 or older.
- Description of Treatment
- Participants enrolled in this study will have their dasatinib treatment discontinued. They will be followed for 5 years to monitor the maintenance of Major Molecular Response (MMR). If MMR is lost, dasatinib treatment will be resumed at the dose level the participant was receiving before enrollment and remain on treatment for the remainder of the study. The doctor may adjust treatment as needed. All study procedures will continue.
- Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
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last updated: 13-Oct-15 11:43 AM
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