Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Cutaneous T-cell Lymphoma (CTCL)
Both
Cutaneous T-cell Lymphoma (CTCL)
Trial Information
Inclusion Criteria:
- Adult patients with advanced CTCL
- Have had at least 2 systemic therapies
- Must have evaluable disease
- Eastern Cooperative Oncology Group performance status 0-2
- Adequate bone marrow, hepatic and renal function
- At least 3 weeks from prior therapies
- Not receiving topical steroids or have been on a stable dose of topical steroids for
at least 2 weeks
- Able to swallow capsules
- At least 3 weeks from major surgery
- Agree to practice effective contraception
- Able to understand and willing to sign the informed consent form
Exclusion Criteria:
- Receiving systemic steroids
- Receiving topical or systemic retinoids or vitamin A
- Receiving radiotherapy, biological therapy,or any other investigational agents
- Uncontrolled intercurrent illness
- Pregnant or lactating women
- Known to be HIV-positive
- Active hepatitis B and/or hepatitis C infection
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
response rate in overall skin disease
Outcome Time Frame:
over the course of study
Safety Issue:
No
Principal Investigator
Judy H Chiao, M.D.
Investigator Role:
Study Director
Investigator Affiliation:
Cyclacel Pharmaceuticals, Inc.
Authority:
United States: Food and Drug Administration
Study ID:
CYC682-06-05
NCT ID:
NCT00476554
Start Date:
April 2007
Completion Date:
March 2012
Related Keywords:
- Cutaneous T-cell Lymphoma (CTCL)
- CTCL
- Lymphoma
- Lymphoma, T-Cell
- Lymphoma, T-Cell, Cutaneous
Name | Location |
|---|---|
| The University of Texas MD Anderson Cancer Center | Houston, Texas 77030-4009 |
| Stanford University Hospitals and Clinics | Stanford, California 94305 |
| Timothy Kuzel, M.D. | Chicago, Illinois 60611 |
