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Study of Vorinostat (MK0683) With Follicular Lymphoma (FL), Other Indolent B-cell Non-Hodgkin's Lymphoma (B-NHL) or Mantle Cell Lymphoma (MCL) Patients (MK-0683-103)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: April 2, 2009
Last updated: February 13, 2017
Last verified: February 2017
This study evaluates safety and tolerability of MK0683 and efficacy of MK0683 in patients with relapsed and/or refractory FL. Exploratory purpose of this study is to evaluate efficacy of MK0683 in patients with relapsed and/or refractory other Indolent B-NHL or MCL.

Condition Intervention Phase
Drug: vorinostat
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Phase II Study of MK0683 in Patients With Relapsed / Refractory Follicular Lymphoma (FL), Other Indolent B-cell Non-Hodgkin's Lymphoma (B-NHL) or Mantle Cell Lymphoma (MCL)

Resource links provided by NLM:

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Overall Response Rate [ Time Frame: 21 Months ]

Secondary Outcome Measures:
  • Time to event efficacy endpoints 2)Any clinical or laboratory adverse experiences [ Time Frame: 21 Months ]

Estimated Enrollment: 54
Study Start Date: April 2009
Estimated Study Completion Date: January 2018
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Drug: vorinostat
MK0683 (200 mg capsule) Oral, twice daily (400 mg/day) for Day 1 through 14 of a 21 day cycle


Ages Eligible for Study:   20 Years to 74 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patient Is 20 To 74 Years Old
  • Patient Has An Histopathologically Confirmed Fl, Or Other Indolent B-Nhl Or Mcl (Only Relapsed / Refractory Fl Can Be Included Outside Japan.)
  • Patient Has At Least One Measurable Lesion By Ct Scan Which Is Defined By Cheson's 1999 Criteria
  • Patient Has Received At Least 1 But Up To 4 Prior Chemotherapeutic Regimen, 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.
  • Patient Must Have Adequate Organ And Marrow function

Exclusion Criteria:

  • Patient Who Has Undergone Allogenic Transplant Treatment Or Autologous Stem Cell Transplant Within 6 Months
  • Patient With Other Active Malignancies Or Central Neurological Infiltration With Lymphoma
  • Patient With Severe Hepatic Insufficiency
  • Patient With History Of Allergic Reactions Attributed To Any Component Of MK0683
  • Patient Who Is Known To Be HIV Antibody-, Hbv Antigen- Or Hcv Antibody-Positive
  • Patient Who Has Undergone Prior/Concomitant Treatment With MK0683 Or Other Hdac Inhibitors
  Contacts and Locations
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Please refer to this study by its identifier: NCT00875056

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00875056     History of Changes
Other Study ID Numbers: 0683-103
132248 ( Registry Identifier: JAPIC-CTI )
Study First Received: April 2, 2009
Last Updated: February 13, 2017

Additional relevant MeSH terms:
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Lymphoma, Mantle-Cell
Lymphoma, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on April 27, 2017