Study of Vorinostat (MK-0683) With Follicular Lymphoma (FL), Other Indolent B-cell Non-Hodgkin's Lymphoma (B-NHL), or Mantle Cell Lymphoma (MCL) Participants (MK-0683-103)
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, Follicular; Lymphoma, Non-Hodgkin; Lymphoma, Mantle-Cell; Lymphoma, B-Cell
Intervention: Vorinostat
Intervention description: Two 100 mg oral capsules of vorinostat, twice daily (400 mg/day), on Days 1 through 14 of each 21 day cycle
Intervention MeSH terms: Vorinostat
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: All participants received the same drug regimen but were allocated to groups based on disease type.
Masking: None (Open Label)
Enrollment: 56.0
Sex: All
Minimum age: 20 Years
Maximum age: 74 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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)

               -  Only relapsed/refractory FL can be included outside Japan

          -  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:

          -  Participant has undergone allogenic transplant treatment or autologous stem cell
             transplant within 6 months

          -  Participant with other active malignancies or central neurological infiltration with
             lymphoma

          -  Participant with severe hepatic insufficiency

          -  Participant with history of allergic reactions attributed to any component of MK-0683

          -  Participant is known to be human immunodeficiency virus (HIV) antibody-, hepatitis B
             virus antigen- or hepatitis C virus antibody-positive

          -  Participant has undergone prior/concomitant treatment with MK-0683 or other histone
             deacetylase (HDAC) inhibitors