Know Cancer

or
forgot password

A Multicenter Phase III Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy of Two Dose Levels of DAB389IL-2 (9 and 18 Mcg/kg/Day) in Cutaneous T-Cell Lymphoma (CTCL) Patients With Stage Ia-III Disease Who, Following Less Than or Equal to 3 Previous Therapies, Have Recurrent or Persistent Disease That Has Been Biopsy-Documented to Express CD25


Phase 4
18 Years
N/A
Not Enrolling
Both
Lymphoma, T-Cell, Cutaneous, Mycosis Fungoides, Sezary Syndrome

Thank you

Trial Information

A Multicenter Phase III Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy of Two Dose Levels of DAB389IL-2 (9 and 18 Mcg/kg/Day) in Cutaneous T-Cell Lymphoma (CTCL) Patients With Stage Ia-III Disease Who, Following Less Than or Equal to 3 Previous Therapies, Have Recurrent or Persistent Disease That Has Been Biopsy-Documented to Express CD25


Inclusion Criteria:



- Histopathologically confirmed recurrent or persistent CTCL as determined by reference
pathology lab;

- Patient must have had 1 to 3 prior CTCL therapies. Repeated use of the same agent is
considered to be 1 therapy unless it is part of a different combination regimen.
Only 1 prior combination cytotoxic regimen is permitted. Topical or systemic
steroids are not considered a therapy;

- Interleukin-2 receptor (IL-2R) expression on at least 20% of tumor cells as
determined by immunohistochemistry.

- Stage IA - III disease and unlikely to progress during the first month on study.
Life expectancy of at least 12 months.

- Measurable or evaluable disease. Lymph node involvement no greater than LN2. No
CTCL involvement of bone marrow.

- No active CNS disease, kidney or liver disease, significant pulmonary disease, or
cardiac disease.

- No systemic infections;

- Willingness to be randomized to a placebo treatment only arm;

- ECOG performance status 0 or 1;

Exclusion Criteria:

• Patients must not have previously received treatment with DAB389IL-2 or DAB486IL 2
(previous candidate compound evaluated in a clinical setting).

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

Objective Rate of Response (ORR), defined as CR + CCR + PR

Principal Investigator

Elyane Lombardy, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Ligand Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

93-04-11

NCT ID:

NCT00050999

Start Date:

June 1995

Completion Date:

December 2006

Related Keywords:

  • Lymphoma, T-Cell, Cutaneous
  • Mycosis Fungoides
  • Sezary Syndrome
  • Lymphoma
  • Mycoses
  • Mycosis Fungoides
  • Sezary Syndrome
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Cutaneous

Name

Location

University of Texas, M.D. Anderson Cancer CenterHouston, Texas  77030