Efficacy and safety of tisagenlecleucel in adult patients with refractory or relapsed follicular lymphoma

Phase 1

• Conditions: Adult patients with refractory or relapsed follicular lymphoma; MedDRA version: 20.0Level: HLTClassification code 10016903Term: Follicle centre lymphomas, follicular grade I, II, IIISystem Organ Class: 100000004851; MedDRA version: 20.0Level: PTClassification code 10061170Term: Follicle centre lymphoma, follicular grade I, II, IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-004385-94-NL
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-27
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 113

Inclusion Criteria

•Written informed consent prior to any screening procedures
•=18 years of age at the time of ICF signature
•FL (Grade 1, 2, 3A) confirmed histologically by central pathology review before tisagenlecleucel infusion.
•FL meeting one of the following criteria:
oRefractory 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
oRelapsed during anti-CD20 antibody maintenance (following at least two lines of therapies as above) or within 6 months after maintenance completion
oRelapsed after autologous HSCT
•Radiographically measurable disease at screening defined as:
•At least one nodal lesion greater than 20 mm in the long axis, regardless of the length of the short axis AND/OR
•Extranodal lesions (outside lymph node or nodal mass, including liver and spleen) greater than 10 mm in long AND short axis

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 23

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 clinical trial of medicinal product
• Study Design: Not specified