Research & Trial Information
Protocol#: SWOG – S1712
Cancer Type: Chronic Myeloid Leukemia CLL
- Patients must have a diagnosis of chronic phase chronic myeloid leukemia without any history of progression to accelerated or blast phase CML. No new bone marrow aspiration and biopsy is needed to prove diagnosis prior to randomization; however, documentation stating the patient is in chronic phase is required.
- Patients must have detectable BCR-ABL transcripts measured by RT-PCR at a CLIA-approved laboratory and reported on the International Scale (IS) with a value of > 0.0032% IS and ≤ 1.0% IS within 21 days prior to randomization. The RT-PCR assay must have the sensitivity to detect a 4.5 log reduction in BCR-ABL transcripts from baseline (at least 0.0032% IS).
- Patients must be receiving treatment with dasatinib (within the allowable dose range of 70-100 mg daily) or nilotinib (within the allowable dose range of 200-400 mg BID) as first or second line therapy for a minimum of 6 months prior to registration.
- Patients must not have received > 2 TKIs for treatment of CML (hydroxyurea prior to initiation of TKI is allowed).
- Patients must have been on their current TKI for a minimum of 6 months prior to randomization.
- If dasatinib or nilotinib is second-line therapy, the reason for stopping first-line treatment must not have been resistance to prior treatment or failure to achieve an adequate response on their first-line TKI (e.g., the patient could have stopped due to intolerance to prior TKI).
- Patients must have been receiving TKI treatment for CML for at least one year and no more than 10 years prior to randomization.
- Patients must be expected to remain on the same TKI for the next 12 months.
- Patients must not be receiving any other investigational agents.
- Patients must be ≥ 18 years of age.