Phase II Open Label Trial to Determine Safety & Efficacy of Tisagenlecleucel in Pediatric Non-Hodgkin Lymphoma Patients (BIANCA)

Condition(s)
Lymphoma

Age Group
0-9 years 10-17 years 18-26 years

Phase(s)
2

Biological treatment cell Biological
Tisagenlecleucel
Trial Summary

The purpose of the study is to assess the efficacy and safety of tisagenlecleucel in children and adolescents with relapsed/refractory B-cell non-Hodgkin lymphoma (r/r B-NHL). For pediatric patients who have r/r B-NHL, survival rates are dismal, only ~20-50% subjects are alive at 2 years with overall response rate (ORR) of 20-30% after conventional salvage chemotherapy.

Ages: up to 18 Years
Condition: Non-Hodgkin Lymphoma
Status
Recruiting
Location(s)
Childrens Hospital Los Angeles, Los Angeles, CA
Memorial Sloan Kettering Cancer Center, New York, NY
Cincinnati Childrens Hospital Medical Center, Cincinnati, OH
University of Texas Southwestern Medical Center, Dallas, TX

Novartis Investigative Site, Wien, Austria
Novartis Investigative Site, Toronto, Ontario, Canada
Novartis Investigative Site, Paris Cedex, France
Novartis Investigative Site, Villejuif Cedex, France
Novartis Investigative Site, Sakyo Ku, Kyoto, Japan
Novartis Investigative Site, Barcelona, Barcelona/ Cataluny/Espanya, Spain
Contact
Novartis Pharmaceuticals
888-669-6682