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A Multicenter Open-Label Study to Evaluate the Safety and Efficacy of DAB389IL-2 in Cutaneous T-Cell Lymphoma (CTCL) Patients Following Protocol 93-04-10, Protocol 93-04-11, or Protocol 92-04-01 or Who Meet the Requirements for Protocol 93-04-11 Except Have Biopsy-Documented CTCL That Does Not 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 Open-Label Study to Evaluate the Safety and Efficacy of DAB389IL-2 in Cutaneous T-Cell Lymphoma (CTCL) Patients Following Protocol 93-04-10, Protocol 93-04-11, or Protocol 92-04-01 or Who Meet the Requirements for Protocol 93-04-11 Except Have Biopsy-Documented CTCL That Does Not Express CD25


Inclusion Criteria:



- Patient must have been previously enrolled in Protocol 93-04-11 and randomized to the
placebo arm; or the patient met all eligibility criteria for protocol 93-04-11 other
than the expression of CD25 on CTCL tumor cells.

- CTCL disease Stage Ia - III.

- History of less than or equal to 3 previous 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 chemotherapy regimen is permitted.
Topical or systemic steroids are not considered a therapy.

- Patient must have evaluable or measurable disease. Lymph node involvement no greater
than LN2. No CTCL involvement of bone marrow.

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

- No systemic infections.

- ECOG performance status of 0 or 1.

Exclusion Criteria:

• The 93-04-14 study is no longer open to subjects previously enrolled in 93-04-10 or
92-04-01.

Type of Study:

Interventional

Study Design:

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

93-04-14

NCT ID:

NCT00051012

Start Date:

September 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