A randomized phase II trial of Interferon + GM-CSF versus K562/GM-CSF vaccination in CML patients achieving a complete cytogenetic response to frontline tyrosine kinase therapy
B Douglas Smith
To determine whether sequential, combination therapy can improve clinical responses of single agent imatinib for patients with Ph+ CML in chronic phase in cytogenetic remission. The primary clinical endpoint of the study will be progression-free survival at one year of molecular complete remissions obtained on combination therapy following discontinuation of all therapy. The secondary clinical endpoint will be the rate of molecular CR in each of two treatment arms described as follows: All subjects will be treated with imatinib mesylate and will have achieved a complete cytogenetic remission. Subjects will then be randomized to receive either Study Arm A) interferon-? + GM-CSF or Study Arm B) a series of K562/GM-CSF vaccinations in combination with imatinib mesylate. All subjects achieving a molecular CR after a minimum duration of combination therapy will then have the combination discontinued. Subjects who do not achieve a molecular CR after 1 year of combination therapy are eligible to cross over to the other study arm.
Ph+ CML. The diagnosis of chronic phase CML based on cytogenetic detection of the Ph chromosome and/or detection of the BCR-ABL rearrangement by molecular analysis (recombinant DNA analysis of the BCR-ABL fusion gene, fluorescence in situ hybridization, or polymerase chain reaction detection of the BCR-ABL hybrid mRNA). Documentation of complete cytogenetic response (CCR) by conventional cytogenetics or FISH analysis on a stable imatinib dose.
Arm A: Inerferon-alfa and Sargramostim Vaccine Arm B: K562/GM-CSF Vaccination and Imatinib
05/22/2013 04:02 AM