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Phase 2
18 Years
N/A
Not Enrolling
Both
Cutaneous T-cell Lymphoma (CTCL)

Thank you

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 CenterHouston, Texas  77030-4009
Stanford University Hospitals and ClinicsStanford, California  94305
Timothy Kuzel, M.D.Chicago, Illinois  60611