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Phase 2
18 Years
Not Enrolling
Cutaneous T-Cell Lymphoma

Thank you

Trial Information

Inclusion Criteria

Inclusion criteria

- Medical diagnosis of CTCL, and positivity for the CD4 receptor.

- Late stage CTCL.

- Have received at least one prior anti-cancer therapy with inadequate effect.

- WHO performance status 0,1 or 2

- Male or female, age 18 or older.

- Signed informed consent.

Exclusion Criteria

- Certain rare types of CTCL.

- Previous treatment with other anti-CD4 medications.

- More than two previous treatments with systemic chemotherapy.

- Certain anti-psoriasis or anti-cancer therapies within the last 4 weeks before
entering this trial.

- Some types of steroid treatments less than two weeks before entering the trial.

- Prolonged exposure to sunlight or UV light during the trial.

- Other cancer diseases, except certain skin cancers or cervix cancer.

- Chronic infectious disease requiring medication.

- Certain serious medical conditions, including kidney or liver disease, some
psychiatric illnesses, and stomach, lung, heart, hormonal, nerve or blood diseases.

- Certain laboratory values which are too high or too low.

- HIV positivity.

- Pregnant or breast-feeding women.

- Women of childbearing age who are unable or unwilling to use an IUD or hormonal birth
control during the whole trial.

- If you are participating in another trial with a different new drug 4 weeks before
you enter this trial.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Composite assessment of index lesion activity (CA Score)

Outcome Time Frame:

20 weeks

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

May 2003

Completion Date:

Related Keywords:

  • Cutaneous T-cell Lymphoma
  • Skin cancer
  • Lymphoma
  • Mycosis fungoides
  • Sezary syndrome
  • Lymphoma
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Cutaneous



University of Texas, M.D. Anderson Cancer Center Houston, Texas  77030
Stanford University Med Ctr., Dept of Dermatology Stanford, California  94305-5152