Trial Information: 87 patients with indolent lymphoma (including follicular lymphoma), mantle cell lymphoma, and Hodgkin's disease will be given SB1518 orally, one dose per day, beginning with a four-week (28-day) cycle. The dosage is not indicated on ClinicalTrials.gov, but another Phase II trial is currently evaluating a 200 mg dosage, while the Phase I trials suggested that at least 600 mg was tolerable.
Background Information: SB1518 is an experimental new Janus kinase-2 (JAK-2) inhibitor from S*BIO. Results from a Phase I trial were published at the December 2010 ASH convention. This trial included 30 patients with a range of aggressive and indolent lymphomas. "Mild" side effects (diarrhea, constipation, and fever) were common, but the most frequent serious effect (low white blood cell counts, aka neutropenia) was found in 7%. Of eight follicular lymphoma patients, 1 had a partial response and 7 had stable disease. In contrast, two of three mantle cell lymphoma patients responded. No other lymphomas responded.
After the presentation at ASH, two Phase II studies were entered into the ClinicalTrials.gov database, this one and another which is exclusively American.
Canadian Locations: University of British Columbia (Vancouver, BC)
For further information, see ClinicalTrials.gov.
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