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


Phase 2
18 Years
N/A
Not Enrolling
Both
B-Cell Lymphoma

Thank you

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

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