drugset / Trial / NCT05387616
A Prospective Multicenter Phase 2 Study of the Chemotherapy-Free Combination of the Intravenous Phosphatidylinositol-3-Kinase (PI3K) Inhibitor Copanlisib in Combination With Obinutuzumab in Patients With Previously Untreated Follicular Lymphoma (FL) and a High Tumor Burden
Phase 2
Unknown
98 enrolled
Ludwig-Maximilians - University of Munich
Bayer · collabRoche Pharma AG · collab
NaSingle-groupOpen-labelTreatment
Summary
The Alternative-C Trial is a prospective, multicenter Phase 2 Study to evaluate the efficacy of the chemotherapy-free combination of copanlisib and obinutuzumab in patients with previously untreated follicular lymphoma (FL) and a high tumor burden. Additionally, the combination should be evaluated in terms of secondary efficacy endpoints, treatment compliance, safety and patient-reported symptoms. The study Population includes Patients \> 18 years of age with histologically confirmed follicular lymphoma grade 1, 2 or 3A with Ann Arbor Stage III/IV or stage II not suitable for radiotherapy and in need of therapy.
Timeline
- Start
- 2020-10-19
- Primary completion
- 2023-09-16
- Completion
- 2026-05-19
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Copanlisib | Small molecule | 60 mg | Intravenous |
| Subject | Obinutuzumab | Monoclonal antibody | 1000 mg | Intravenous |