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An Investigational Drug Study With Suberoylanilide Hydroxamic Acid in Relapsed Diffuse Large B-cell Lymphoma (0683-013)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00097929
Recruitment Status : Completed
First Posted : December 2, 2004
Last Update Posted : April 7, 2017
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
A study to determine the safety, tolerability, and anti-tumor effectiveness of an oral investigational drug in the treatment of relapsed diffuse large B-cell lymphoma.

Condition or disease Intervention/treatment Phase
B-cell Lymphoma Drug: MK0683, vorinostat, Suberoylanilide Hydroxamic Acid (SAHA) / Duration of Treatment 6 Months Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Relapsed Diffuse Large B-Cell Lymphoma (DLBCL)
Actual Study Start Date : May 1, 2005
Actual Primary Completion Date : July 31, 2006
Actual Study Completion Date : July 31, 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Vorinostat

Primary Outcome Measures :
  1. Objective response rate based on FDG-PET and CT scan findings.

Secondary Outcome Measures :
  1. Response duration, Progression-free survival, Time to progression, Time to response, 3-Month and 6-month progression free survival.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patient must be 18 years or older with relapsed Diffuse Large B-cell Lymphoma (DLBCL).
  • Stable disease or better for at least 3 months on most recent treatment
  • Have not received any chemotherapy, radiation therapy, major surgery, or any other investigational therapy for at least 4 weeks prior to entry in this study
  • Adequate blood testing, liver, and kidney function as required by the study.
  • Eligible subjects will allow tissue samples to be examined and stored.

Exclusion Criteria:

  • Patient has been treated with other investigational agents with a similar anti-tumor mechanism.
  • Patient should not have failed more than 3 prior treatment regimens.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00097929

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
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Study Director: Medical Monitor Merck Sharp & Dohme Corp.
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Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00097929    
Obsolete Identifiers: NCT00124631
Other Study ID Numbers: 0683-013
First Posted: December 2, 2004    Key Record Dates
Last Update Posted: April 7, 2017
Last Verified: April 2017
Keywords provided by Merck Sharp & Dohme Corp.:
Relapsed Diffuse Large B-cell Lymphoma
Additional relevant MeSH terms:
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Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Antineoplastic Agents
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action