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

Phase 2

Completed

• Conditions: B-cell Lymphoma

• Registration Number: NCT00097929
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2004-12-01
• Study First Submitted QC: 2004-12-01
• Study First Posted: 2004-12-02
• Study Start: 2005-05-01
• Primary Completion: 2006-07-31
• Study Completion: 2006-07-31
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-05
• Last Update Posted: 2017-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

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