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About
The purpose of this study is to evaluate the safety, tolerability, and efficacy of vorinostat (MK-0683) in participants with relapsed and/or refractory follicular lymphoma. The exploratory purpose of this study is to evaluate efficacy of MK-0683 in participants with relapsed/refractory non-FL indolent B-NHL or relapsed/refractory MCL. The primary hypothesis is that MK-0683 will show efficacy in relapsed/refractory FL patients as measured by the Overall Response Rate.
Enrollment
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Inclusion criteria
Participant has an histopathologically confirmed follicular lymphoma (FL), or other indolent B-cell non-Hodgkin's lymphoma (B-NHL) or mantle cell lymphoma (MCL)
Participant has at least one measurable lesion by computerized tomography (CT) scan which is defined by Cheson's 1999 criteria
Participant has received at least 1 but up to 4 prior chemotherapeutic regimens, the most recent therapy must have failed to induce a partial response, or there must be recurrence in case of the most recent therapy has shown complete response, or there must be relapse in case of the most recent therapy has shown partial response
Life expectancy of >4 months
Participant must have adequate organ and marrow function
Women of child bearing potential must be negative for pregnancy and agree to use effective contraceptive measures until 30 days after the last dose of MK-0683.
Men must agree to use effective contraceptive measures until 6 months after the last dose of MK-0683
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
56 participants in 3 patient groups
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Data sourced from clinicaltrials.gov
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