A Phase II, single arm, multicenter open label trial to determine the efficacy and safety of tisagenlecleucel (CTL019) in adult patients with refractory or relapsed follicular lymphoma

Phase 2

Recruiting

• Conditions: blood cancer; Follicular Lymphoma; 10025320

• Registration Number: NL-OMON55846
• Lead Sponsor: ovartis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 4

Inclusion Criteria

- Written informed consent prior to any screening procedures
- >=18 years of age at the time of ICF signature
- Follicular Lymphoma (Grade 1, 2, 3A) confirmed histologically by central
pathology review before tisagenlecleucel infusion.
- FL meeting one of the following criteria:
o Refractory to a second line or later line of systemic therapy (including
anti-CD20 antibodies and alkylating agents) or relapsed within 6 months after
completion of a second line or later line of systemic therapy
o Relapsed during anti-CD20 antibody maintenance (following at least two
lines of therapies as above) or within 6 months after maintenance completion
o Relapsed after autologous Hematopoietic Stam Cell Transplant
- Radiographically measurable disease at screening

Exclusion Criteria

- Evidence of histologic transformation
- Follicular Lymphoma Grade 3B
- Prior anti-CD19 therapy
- Prior gene therapy
- Prior adoptive T cell therapy
- Prior allogeneic hematopoietic stem cell transplant
- Active CNS involvement by malignancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Evaluate the efficacy of tisagenlecleucel therapy as measured by complete<br /><br>response rate determined by Independent Review Committee in the full analysis<br /><br>set based on Lugano 2014 classification response criteria.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Evaluate the efficacy of tisagenlecleucel as measured by additional efficacy<br /><br>measures, including Overall Response Rate (ORR), Duration of Response (DOR),<br /><br>Progression Free Survival (PFS) and Overall Survival (OS).<br /><br>- Evaluate safety of tisagenlecleucel<br /><br>- Characterize the in vivo cellular kinetics (levels, expansion, persistence)<br /><br>of tisagenlecleucel transduced cells into target tissues (blood, bone marrow,<br /><br>and other tissues if available) and CD3+ tisagenlecleucel cells in peripheral<br /><br>blood<br /><br>- Characterize the incidence and prevalence of tisagenlecleucel immunogenicity<br /><br>(humoral and cellular)<br /><br>- Characterize the impact of pre-existing and treatment induced immunogenicity<br /><br>on cellular kinetics, efficacy and safety<br /><br>- Describe the effect of tisagenlecleucel therapy on patient reported outcomes</p><br>