Phase 2
Completed N=56
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)
Source: ClinicalTrials.gov NCT00875056 ↗Enrolled (actual)
56
Serious AEs
37.5%
Results posted
Oct 2020
Primary outcomePrimary: Objective Response Rate (ORR) — 48.7; 27.3 Percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate (ORR) |
48.7; 27.3 | — |
| PRIMARY Number of Participants Who Experienced an Adverse Event (AE) |
39; 11; 6 | — |
| PRIMARY Number of Participants Who Discontinued Study Drug Due to Experiencing an Adverse Event (AE) |
6; 1; 2 | — |
| SECONDARY Time to Treatment Failure for Relapsed/Refractory FL |
323 | — |
| SECONDARY Time to Response for Relapsed/Refractory FL |
NA | — |
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
Data sourced from ClinicalTrials.gov (NCT00875056). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.