Tisagenlecleucel in Adult Patients With Aggressive B-cell Non-Hodgkin Lymphoma

Active:	No
Cancer Type:	Hematopoietic Malignancies Lymphoma Non-Hodgkin Lymphoma Unknown Primary	NCT ID:	NCT03570892
Trial Phases:	Phase III	Protocol IDs:	CCTL019H2301 (primary) NCI-2018-02925 2016-002966-29
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Novartis Pharmaceuticals Corporation
NCI Full Details:	http://clinicaltrials.gov/show/NCT03570892

Summary

This is a randomized, open label, multicenter phase III trial comparing the efficacy,
safety, and tolerability of tisagenlecleucel to Standard Of Care in adult patients with
aggressive B-cell Non-Hodgkin Lymphoma after failure of rituximab and anthracycline
containing frontline immunochemotherapy.

Objectives

Approximately 318 subjects were planned to be randomized; 322 subjects were analyzed
(Full analysis set): 162 subjects in the tisagenlecleucel arm and 160 subjects in the SOC
arm.

The target population consisted of adult participants with aggressive B-cell non-Hodgkin
lymphoma (NHL) who were relapsed/refractory within 365 days of their last dose of first
line immunochemotherapy and eligible for autologous hematopoietic stem cell
transplantation (HSCT).

The duration of treatment in the tisagenlecleucel treatment strategy is from the start of
bridging chemotherapy (if applicable) until the infusion of tisagenlecleucel (expected on
average at approximately 6 weeks from randomization). The duration of the treatment in
the SOC treatment strategy is from the start of salvage chemotherapy until autologous
HSCT. In either treatment arm, if infusion of tisagenlecleucel or autologous HSCT is not
possible, the duration of treatment is until the last dose of study treatment prior to
discontinuation of the treatment strategy.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

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