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NCT05387616: Alternative-C
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 trial testing Copanlisib in Follicular Lymphoma in 98 participants. Participants enrolled and being followed up; not accepting new ones.
16 September 2023
Quick facts
| Lead sponsor | Ludwig-Maximilians - University of Munich |
|---|---|
| Phase | Phase 2 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 98 |
| Start date | 19 October 2020 |
| Primary completion | 16 September 2023 |
| Estimated completion | 19 May 2026 |
| Sites | 40 locations across Germany |
Drugs / interventions tested
- Copanlisib (COPANLISIB) — full drug profile →
- Obinutuzumab — full drug profile →
Conditions studied
- Follicular Lymphoma — all drugs for Follicular Lymphoma →
Sponsor
Ludwig-Maximilians - University of Munich
Who can join
18 and older, any sex, with Follicular Lymphoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Current State and Future Challenges for PI3K Inhibitors in Cancer Therapy.
Sirico M, D'Angelo A, Gianni C, Casadei C, et al · · 2023 · cited 76× · PMID 36765661 · DOI 10.3390/cancers15030703 -
Small-molecule agents for cancer immunotherapy.
Wang F, Fu K, Wang Y, Pan C, et al · · 2024 · cited 41× · PMID 38486980 · DOI 10.1016/j.apsb.2023.12.010 -
Targeting PI3K Signaling to Overcome Tumor Immunosuppression: Synergistic Strategies to Enhance Cancer Vaccine Efficacy.
Cui R, Luo Z, Zhang X, Yu X, et al · · 2025 · cited 10× · PMID 40266213 · DOI 10.3390/vaccines13030292 -
Molecular Basis of Oncogenic PI3K Proteins.
Sheng Z, Beck P, Gabby M, Habte-Mariam S, et al · · 2024 · cited 1× · PMID 39796708 · DOI 10.3390/cancers17010077
Verify or expand the search:
- PubMed search for NCT05387616
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Copanlisib
Trials testing the same drug.
- NCT05082025 — Phase 2 Study of PI3K Inhibitor Copanlisib in Combination With Fulvestrant in Selected ER+ and/or PR+ Cancers With PI3K · Phase 2 · terminated
- NCT04933617 — Copanlisib With Dose-Adjusted EPOCH-R in Relapsed and Refractory Burkitt Lymphoma and Other High-Grade B-cell Lymphomas · Phase 1 · terminated
- NCT05010096 — BAY1895344 and Copanlisib for the Treatment of Molecularly Selected Patients With Advanced Solid Tumors · Phase 1 · withdrawn
- NCT04750941 — Study of Copanlisib and Ketogenic Diet · Phase 2 · terminated
- NCT04572763 — Copanlisib Plus Venetoclax in R/R DLBCL · Phase 1, PHASE2 · active not recruiting
Other recruiting trials for Follicular Lymphoma
Currently open trials in the same condition.
- NCT07128641 — Odronextamab in Low Tumor Volume Advanced FL · Phase 2 · recruiting
- NCT06792825 — HM2023-43:Ph 2 Trial of Tafasitamab With Lenalidomide+Rituximab in Treatment-naive FL and MZL · Phase 2 · recruiting
- NCT06911502 — A Study to Compare the Efficacy and Safety of Golcadomide in Combination With Rituximab (Golca + R) vs Investigator's Ch · Phase 3 · recruiting
- NCT07126678 — Fixed-Duration Zanubrutinib, Bendamustine, and Obinutuzumab (ZBG) in Treatment-Naïve Advanced Stage Follicular Lymphoma · NA · recruiting
- NCT06860880 — Combating Cancer-Related Fatigue: A Personalized Supportive Care Program · NA · recruiting
Other Ludwig-Maximilians - University of Munich trials
Trials by the same sponsor.
- NCT07514520 — Decision-making, Ethical Consent, and Interactive Dialogue in Ongoing Neurocognitive Decline - DECISION · active not recruiting
- NCT07504965 — Dementia-friendly Apothecaries as a Resource for Mental Heath in the Elderly · recruiting
- NCT07100548 — A Qualitative Analysis of Youth Responses to Depression Education Delivered on Social Media · completed
- NCT07061600 — Enhancing Depression Literacy and Reducing Stigma in Adolescents Through Social Media · NA · completed
- NCT06749106 — Plaque Imaging in Routine Care to Detect Intraplaque Hemorrhage · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05387616 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Ludwig-Maximilians - University of Munich
- Last refreshed: 12 March 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05387616.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing