Phase II Study of IMTOX25 in Relapsed/Refractory Cutaneous T-Cell Lymphoma
- Determine the response rate of patients with relapsed or refractory cutaneous T-cell
non-Hodgkin lymphoma (CTCL) following treatment with RFT5-dgA immunotoxin (anti-CD25
immunotoxin IMTOX25) .
- Determine whether responses correlate with the level of CD25+ expression on the CTCL
- Determine whether changes in the pre-treatment and the post-treatment levels of
CD4+CD25+ Treg cells correlate with responses.
OUTLINE: Patients receive anti-CD25 immunotoxin IMTOX25 IV over 4 hours on days 1, 3, and 5.
Treatment repeats every 6 weeks for 6 courses in the absence of disease progression or
Tissue and blood samples are collected at baseline, and during study for CD25+ expression by
fluorescent-activated cell sorter analysis, immunohistochemistry.
After completion of study therapy, patients are followed every 3 months for 2 years, every 6
months for 2 years, and then annually thereafter.
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
Simrit Parmar, MD
Simmons Cancer Center
United States: Food and Drug Administration
|Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas||Dallas, Texas 75390|