Trial Management Group
|CLC.1 Trial Now Open
We are very pleased to announce the central activation of the CLC.1 trial. This is an intergroup phase III study led by the CALGB in patients with asymptomatic CLL. The trial will examine the role of early intervention with fludarabine and rituximab (FR) in patients identified as high risk based on immunoglobulin heavy chain gene (IgVH) mutation analysis.
At initial registration, asymptomatic individuals within six months of a diagnosis of CLL will have mutation testing performed at a central laboratory. These results will be available to the investigator and participant within 60 days. At second registration, high risk (IgVH unmutated) participants will be randomized to FR vs. observation, while the low-risk (IgVH mutated) group will be offered observation within the context of a prospective cohort study; once symptomatic, participants will be eligible to receive FR. In Canada, both oral and iv fludarabine are permitted. Rituximab will be provided by Roche Pharmaceuticals. The estimated sample size for the high risk arm is 700, while 500 participants are required for the low risk arm.
Not only do we expect that Canadian centres will be vital contributors to this trial, but innovative Canadian-based correlative science studies and an economic analysis are planned. We urge Canadian investigators to proceed with activation of this large and important trial. Trial-related questions can be forwarded to the Canadian P.I. Matthew Seftel, or to the Chairs of the Hematologic Disease Site Committee, Stephen Couban and Michael Crump.
Dr. Matthew Seftel Dr. Stephen Couban Dr. Michael Crump
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To see the trial protocol including the trial schema, please go to the trial website http://www.ctg.queensu.ca/trials/hematologic/clc1/clc1.html.