Trial Information

Summary: Study of autografting for advanced phase chronic myeloid leukemia

This study will evaluate the utility of autografting for patients with advanced phase CML. To suppress the leukemia an intermediate dose of the chemotherapeutic drug busulfan will be used. The dose is 'intermediate' because it is higher than that employed for treatment of chronic phase disease, but only half the amount that is traditionally used for autografting. The dose of the chemotherapy has been reduced in an attempt to prolong life with minimal toxicity and disruption to the patient.

Patients must fulfill standard criteria for the diagnosis of chronic phase CML at the time of initial entry into the study and leukapheresis. At the time of autografting, they must have evidence of advanced phase CML, including:

• Typical blood and marrow morphology
• Presence of Philadelphia chromosome (or molecular evidence of bcr/abl rearrangements in Philadelphia chromosome-negative patients).
• Marrow or blood blast count > 10%, or additional evidence of advanced disease, such as the presence of myelofibrosis, additional non-random chromosomal changes, extra medullary tumor deposits, systemic symptoms such as bone pain, fever, weight loss or enlarging spleen or liver, or worsening leukocytosis, thrombocytosis, or thrombocytopenia despite conventional therapy.

The patient physiological age must be < 65 years and there must be consensus agreement that autologous transplantation is appropriate after discussion at Adult Leukemia/Lymphoma/Hematology Conference.

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Trial listings updated: June 1, 2008 at 5:43:10 AM