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

April 5, 2017 updated by: Merck Sharp & Dohme LLC

A Phase II Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Relapsed Diffuse Large B-Cell Lymphoma (DLBCL)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Objective response rate based on FDG-PET and CT scan findings.

Secondary Outcome Measures

Outcome Measure
Response duration, Progression-free survival, Time to progression, Time to response, 3-Month and 6-month progression free survival.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2005

Primary Completion (Actual)

July 31, 2006

Study Completion (Actual)

July 31, 2006

Study Registration Dates

First Submitted

December 1, 2004

First Submitted That Met QC Criteria

December 1, 2004

First Posted (Estimate)

December 2, 2004

Study Record Updates

Last Update Posted (Actual)

April 7, 2017

Last Update Submitted That Met QC Criteria

April 5, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0683-013
  • MK0683-013
  • 2004_029

Plan for Individual participant data (IPD)

Study Data/Documents

  1. CSR Synopsis Links

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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