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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

Conditions: B-cell Lymphoma

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00097929

2004_029

MK0683-013

0683-013

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)