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Phase IIb Multicenter Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Advanced Cutaneous T-cell Lymphoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Cutaneous T-cell Lymphoma, Sezary Syndrome, Mycosis Fungoides

Thank you

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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