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

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 (r/r) follicular lymphoma

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1080224541

Enrollment

Registered

2019-01-31

Start date

2018-11-12

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Follicular Lymphoma

Interventions

A single intravenous (i.v.) infusion of CTL019.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Refractory or relapsed Follicular Lymphoma (Grade 1, 2, 3A) Radiographically measurable disease at screening

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
efficacy CRR (Complete response rate)	—

Secondary

Measure	Time frame
Evaluate Overall Response Rate (ORR), duration of response (DOR) , relapse free survival (RFS), progression free survival (PFS), and overall survival (OS) Safety Immunogenicity and cellular kinetics	—

Countries

Asia except Japan, Europe, Japan, North America, Oceania, South America

Contacts

Public ContactKyosuke Yamauchi

Novartis Pharma. K.K.

rinshoshiken.toroku2@novartis.com+81-120-003-293

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026