Phase IIb Multicenter Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Advanced Cutaneous T-cell Lymphoma
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Cutaneous T-cell Lymphoma, Sezary Syndrome, Mycosis Fungoides
Both
Cutaneous T-cell Lymphoma, Sezary Syndrome, Mycosis Fungoides
Trial Information
Phase IIb Multicenter Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Advanced Cutaneous T-cell Lymphoma
Inclusion Criteria:
- Patients with Cutaneous T-cell Lymphoma (Stage 1B or higher)
- Age: over 18 years of age
- Have the ability to swallow capsules.
- You must be at least 3 weeks from any prior chemotherapy or anticancer therapy
treatment and have recovered from any side effects of that treatment.
- Patients also require adequate heart, liver, and kidney function.
Exclusion Criteria:
- Pregnant and nursing women and those with known allergy to the study drug are
excluded from this study.
- Patients are excluded if they are currently receiving chemotherapy, radiation
therapy, or other investigational anti-cancer therapy.
- Patients diagnosed with HIV, active hepatitis or who require intravenous antibiotics
or antifungal agents are not permitted.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Objective response rate in patients with progressive, persistent, or recurrent disease.
Principal Investigator
Medical Monitor
Investigator Role:
Study Director
Investigator Affiliation:
Merck
Authority:
United States: Food and Drug Administration
Study ID:
2004_015
NCT ID:
NCT00091559
Start Date:
February 2005
Completion Date:
Related Keywords:
- Cutaneous T-cell Lymphoma
- Sezary Syndrome
- Mycosis Fungoides
- CTCL
- Lymphoma
- Mycoses
- Mycosis Fungoides
- Sezary Syndrome
- Lymphoma, T-Cell
- Lymphoma, T-Cell, Cutaneous
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