A Phase I/II, Non-Randomized,Multiple-Dose,Dose Escalation Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of TNX-650 in Patients With Refractory Hodgkin's Lymphoma
Hodgkin's lymphoma (HL) is a lymphoid malignancy that accounts for approximately 7,000 to
8,000 new cancer cases per year in the United Sates. It occurs with a bimodal age-incidence
distribution peaking in the 15- to 30-year old and 50- to 60-year old age groups. The
pathological hallmark of the disease is the presence of malignant Reed Sternberg (RS) cells.
Reed-Sternberg cells are interspersed among a heterogeneous population of non-malignant
reactive cells, including T cells, eosinophils, neutrophils, B lymphocytes, plasma cells,
histiocytes, fibroblasts, and stromal cells.
While more than 80% of patients will respond to initial radiotherapy or combination
chemoradiotherapy, some patients will experience early relapse after initial therapy or be
refractory to first-line therapy. These patients may be treated with second-line therapy,
which may include autologous bone marrow transplantation (BMT). Patients with HL who
relapse after first- and second-line therapy, or who are refractory to therapy, with or
without autologous BMT, have a poor prognosis. The long-term event-free survival rate in
this patient group is less than 10%; median survival is 16 months. At present, these
patients have no treatment options other than investigational therapies.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the safety and tolerability of TNX-650 for Injection when administered to patients with refractory Hodgkin's Lymphoma (HL)
Anas Younes, MD
M.D. Anderson Cancer Center
United States: Food and Drug Administration
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|
|MD Anderson Cancer Center - Dept. of Lymphoma and Myeloma||Houston, Texas 77030-4009|