Dasatinib in Treating Patients With Early Chronic Phase Chronic Myelogenous Leukemia (NCT00254423) | Clinical Trial Compass
CompletedPhase 2
Dasatinib in Treating Patients With Early Chronic Phase Chronic Myelogenous Leukemia
United States150 participantsStarted 2005-11-08
Plain-language summary
The goal of this clinical research study is to learn if BMS-354825 (dasatinib) can help to control CML in chronic phase. The safety of this drug will also be studied.
Who can participate
Age range16 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosis of Ph-positive or Bcr-Abl positive CML in early chronic phase CML (i.e., time from diagnosis \</= 12 months). Except for hydroxyurea, patients must have received no or minimal prior therapy, defined as \<1 month (30 days) of prior IFN-alpha (with or without ara-C) and/or an FDA approved TKI
* Continued from above #1: Clonal evolution defined as the presence of additional chromosomal abnormalities other than the Ph chromosome has been historically been included as a criterion for accelerated phase. However, patients with clonal evolution as the only criterion of accelerated phase have a significantly better prognosis, and when present at diagnosis may not impact the prognosis at all. Thus, patients with clonal evolution and no other criteria for accelerated phase will be eligible for this study
* Age \>/= 16 years (Age \>18 years to participate in optional symptom burden assessment)
* ECOG performance of 0-2
* Adequate end organ function, defined as the following: total bilirubin \<1.5 x ULN, SGPT \<2.5x ULN, creatinine \<1.5x ULN
* Patients must sign an informed consent indicating they are aware of the investigational nature of this study, in keeping with the policies of the hospital.
* Reliable telephone access to receive calls from an interactive voice response system (IVR) (only applicable to patients who will participate in optional symptom burden assessment)
Exclusion Criteria:
* New York Heart Association (NYHA) cardiac class 3-4 heart…
What they're measuring
1
Number of Participants With a Major Molecular Response at 12 Months