Trials / Terminated
TerminatedNCT04161118
TisaGenlecleucel in Elderly Patients With First-Relapsed or Primary Refractory Aggressive B-cell Non-Hodgkin Lymphoma
Phase II Trial of TisaGenlecleucel in Elderly Patients With First-Relapsed or Primary Refractory Aggressive B-cell Non-Hodgkin Lymphoma
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 3 (actual)
- Sponsor
- University of Cologne · Academic / Other
- Sex
- All
- Age
- 60 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
A phase II trial of TisaGenlecleucel (CTL019) in Elderly Patients with First-Relapsed or Primary Refractory Aggressive B-cell Non-Hodgkin Lymphoma
Detailed description
This is a single-arm, prospective, multicenter phase-II trial for elderly patients with aNHL failing 1st-line treatment with immunochemotherapy containing rituximab and anthracycline, who are not eligible for either autologous or allogeneic stem cell transplantation, defined as age \> 65 years, or \> 60 years old with HCT-CI score \>2. This trial evaluates the CMR rate 12 weeks after tisagenlecleucel (CTL019) infusion, the incidence and severity of adverse events, progression-free survival, and overall survival after one and two years after tisagenlecleucel (CTL019).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CTL019 | IV Infusion |
Timeline
- Start date
- 2021-05-12
- Primary completion
- 2023-02-24
- Completion
- 2023-02-24
- First posted
- 2019-11-13
- Last updated
- 2023-05-06
Locations
2 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT04161118. Inclusion in this directory is not an endorsement.