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

  • STATUS
    Recruiting
  • End date
    Feb 15, 2023
  • participants needed
    35
  • sponsor
    Novartis Pharmaceuticals
Updated on 19 January 2022
hodgkin's disease
measurable disease
leukemia
gilbert's syndrome
burkitt's lymphoma
neutrophil count
blood transfusion
follicular lymphoma
diffuse large b-cell lymphoma
b-cell lymphoma
large b-cell lymphoma
autologous hematopoietic stem cell transplant

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.

Description

This study is part of an agreed Pediatric Investigation Plan (PIP). The single-arm study design includes r/r B-cell NHL subject population with poor prognosis, lack of approved effective therapies in this setting. Subject population will include aggressive subtypes of B-cell NHL and will be allowed to receive "bridging therapy" of investigator's choice After assessment of eligibility, subjects qualifying for the study will be enrolled and are allowed to start lymphodepleting chemotherapy as recommended in protocol after which a single dose of tisagenlecleucel product will be infused. The efficacy of tisagenlecleucel will be evaluated through the primary endpoint of Overall Response Rate (ORR) which includes complete response (CR) and partial response (PR) as determined by local assessment. Safety assessments will be conducted through the study completion.

Details
Condition non-hodgkin's lymphoma (nhl), Non-Hodgkin's Lymphoma, Lymphoma
Treatment Tisagenlecleucel
Clinical Study IdentifierNCT03610724
SponsorNovartis Pharmaceuticals
Last Modified on19 January 2022

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