Trial Information
A Phase II Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Relapsed Diffuse Large B-Cell Lymphoma (DLBCL)
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Objective response rate based on FDG-PET and CT scan findings.
Principal Investigator
Medical Monitor
Investigator Role:
Study Director
Investigator Affiliation:
Merck
Authority:
United States: Food and Drug Administration
Study ID:
2004_029
NCT ID:
NCT00097929
Start Date:
May 2005
Completion Date:
Related Keywords:
- B-Cell Lymphoma
- Relapsed Diffuse Large B-cell Lymphoma
- Lymphoma
- Lymphoma, B-Cell
- Lymphoma, Large B-Cell, Diffuse