Trials / Completed
CompletedNCT03568461
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 Follicular Lymphoma
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 98 (actual)
- Sponsor
- Novartis Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years – 100 Years
- Healthy volunteers
- Not accepted
Summary
This is a multi-center, phase II study to determine the efficacy and safety of tisagenlecleucel in adult patients with relapsed or refractory FL.
Detailed description
This single-arm, open label study had the following sequential phases: Screening, Pretreatment, Treatment and Follow-up. In the Pre-treatment phase, the patient could undergo bridging therapy (optional) and lymphodepleting (LD) chemotherapy. Treatment and Follow-up Phase included tisagenlecleucel infusion, and safety and efficacy follow-up for at least 24 months. For all the patients who received tisagenlecleucel infusion, additional survival follow-up was to be performed to determine survival status every 3 months.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | tisagenlecleucel | Tisagenlecleucel is single infusion. |
Timeline
- Start date
- 2018-11-12
- Primary completion
- 2020-11-24
- Completion
- 2025-05-28
- First posted
- 2018-06-26
- Last updated
- 2025-10-07
- Results posted
- 2022-07-22
Locations
31 sites across 12 countries: United States, Australia, Austria, Belgium, France, Germany, Italy, Japan, Netherlands, Norway, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03568461. Inclusion in this directory is not an endorsement.