Phase II Study of Therapy With IMTOX-25 in Adults With Refractory/Relapsed Cd25 Positive Adult T Cell Leukemia/Lymphoma
Adult T Cell Leukemia/Lymphoma (ATL) is a lymphoproliferative disease associated with HTLV-1
infection, characterized by circulating malignant cells expressing the IL-2 receptor (CD25).
Prognosis for patients with ATL remains poor despite advances in chemotherapy, with survival
in leukemic patients ranging from six months to less than one year. Novel agents that are
potent and specific for the tumor cells are urgently needed to improve overall survival and
decrease toxicity in this dismal disease. One therapeutic approach would be to use
immunotoxins (ITs). ITs utilize a potent toxin linked to a targeting moiety designed to
maximize drug delivery to the tumor cells, thus avoiding the nonspecific toxicity of
conventional chemotherapeutic agents. Imtox-25 is constructed using the RFT5 murine
monoclonal antibody (Mab) coupled to deglycosylated ricin-A chain (dgA) via the
heterobifunctional, thiol-containing crosslinker, 4[(succinimidyloxy)
carbonyl]-Ą-methyl-Ą-(2 pyridyldithio) toluene (SMPT). Phase I and II clinical studies
with Imtox-25 (RFT5.dGA) have been shown safety and efficacy in adult patients with
Hodgkin¡¦s disease and a recommended Phase II dose has been established.. In vitro
experiments using ATL cell lines and in vivo studies in a murine xenograft model have
demonstrated significant activity of Imtox-25 in this disease. Based on these results, the
investigators propose to conduct a phase II trial utilizing Imtox-25 in adults with relapsed
or refractory ATL.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
overall response
To determine any anti-tumor activity of Imtox-25 in relapsed/refractory ATL patients within the confines of a Phase II study as defined by overall response
28 days
Yes
Samir Parekh, MD
Principal Investigator
Montefiore Medical Center
United States: Food and Drug Administration
Imtox 25
NCT01378871
December 2009
December 2012
Name | Location |
---|---|
Albert Einstein Comprehensive Cancer Center | Bronx, New York 10461 |
Albert Einstein Clinical Cancer Center | Bronx, New York 10461 |
Albert Einstein Cancer Center at Albert Einstein College of Medicine | Bronx, New York 10461 |
Montefiore Medical Center | Bronx, New York 10467-2490 |
Albert Einstein Cancer Center | Bronx, New York 10461 |
Montefiore Medical Center- | Bronx, New York 10467 |