Trials / Completed
CompletedNCT03806179
Study of Safety and Efficacy of Betalutin and Rituximab in Patients With FL
A Phase 1b Open-label Study of Betalutin in Combination With Rituximab in Patients With Relapsed/Refractory Follicular Lymphoma (Archer-1)
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 7 (actual)
- Sponsor
- Nordic Nanovector · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study is a Phase 1b, open-label, single arm dose escalation study of Betalutin followed by rituximab in patients with previously treated follicular lymphoma. The purpose of this study is to characterise the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary anti-tumour activity of Betalutin in combination with rituximab.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 10 MBq/kg Betalutin | 10 MBq/kg Betalutin, lilotomab 40mg, rituximab 375 mg/m2 |
| DRUG | 15 MBq/kg Betalutin | 15 MBq/kg Betalutin, lilotomab 40mg, rituximab 375 mg/m2 |
Timeline
- Start date
- 2018-10-04
- Primary completion
- 2022-08-08
- Completion
- 2022-08-08
- First posted
- 2019-01-16
- Last updated
- 2023-12-22
- Results posted
- 2023-12-22
Locations
2 sites across 2 countries: Czechia, Norway
Source: ClinicalTrials.gov record NCT03806179. Inclusion in this directory is not an endorsement.