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

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.

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Key information

Conditions

B-cell Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MK0683, vorinostat, Suberoylanilide Hydroxamic Acid (SAHA) / Duration of Treatment 6 Months

Drug

Primary outcomes

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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start: 2005
Primary completion: 2006
Study completion: 2006
First posted: Dec 2, 2004
Registry last updated: Apr 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed