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NCT04790903
A Study Evaluating the Safety, Efficacy and Pharmacokinetics of Venetoclax in Combination With Polatuzumab Vedotin Plus Rituximab (R) and Cyclophosphamide, Doxorubicin, Prednisone (CHP) in Participants With Untreated BCL-2 Immunohistochemistry (IHC)-Positive Diffuse Large B-Cell Lymphoma (DLBCL)
Phase 1 trial testing Venetoclax in Lymphoma, Large B-Cell, Diffuse in 50 participants. Terminated before completion.
21 May 2024
Quick facts
| Lead sponsor | Hoffmann-La Roche |
|---|---|
| Phase | Phase 1 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 50 |
| Start date | 2 July 2021 |
| Primary completion | 21 May 2024 |
| Estimated completion | 21 May 2024 |
| Sites | 20 locations across France, United States, Spain, Italy |
Drugs / interventions tested
- Venetoclax (venetoclax) — full drug profile →
- Polatuzumab Vedotin (POLATUZUMAB VEDOTIN) — full drug profile →
- Rituximab — full drug profile →
- Cyclophosphamide (cyclophosphamide) — full drug profile →
- Doxorubicin
- Prednisone (prednisone) — full drug profile →
Conditions studied
- Lymphoma, Large B-Cell, Diffuse — all drugs for Lymphoma, Large B-Cell, Diffuse →
Sponsor
Hoffmann-La Roche — full company profile →
Who can join
18 and older, any sex, with Lymphoma, Large B-Cell, Diffuse. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This Phase Ib, open-label, multicenter study evaluates the safety, efficacy, and pharmacokinetics of venetoclax in combination with Pola + R-CHP in previously untreated participants with BCL-2 IHC-positive DLBCL. Approximately 50 participants will be enrolled in this study in five consecutive cohorts each consisting of approximately 10 participants.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Immunotherapy for Diffuse Large B-Cell Lymphoma: Current Landscape and Future Directions.
Modi D, Potugari B, Uberti J. · · 2021 · cited 29× · PMID 34830980 · DOI 10.3390/cancers13225827 -
Changing Trends in B-Cell Non-Hodgkin Lymphoma Treatment: The Role of Novel Monoclonal Antibodies in Clinical Practice.
Tavarozzi R, Zacchi G, Pietrasanta D, Catania G, et al · · 2023 · cited 7× · PMID 38001657 · DOI 10.3390/cancers15225397 -
Novel biologic therapies in relapsed or refractory diffuse large B cell lymphoma: CAR-T is not the only answer.
Paillassa J, Safa F. · · 2022 · cited 1× · PMID 35024331 · DOI 10.1016/j.lrr.2021.100282 -
Strategic Combinations of Antibody-Drug Conjugates from 2023 to 2025: From Dual Therapies to Innovative ADC-Based Regimens.
Jang H, Chang JE. · · 2025 · PMID 41471096 · DOI 10.3390/pharmaceutics17121581
Verify or expand the search:
- PubMed search for NCT04790903
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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- NCT07513129 — A Phase 1 Study Of Venetoclax, Dexamethasone, Bortezomib, And Daratumumab (VDBD) For Adolescent And Young Adult Patients · Phase 1 · not yet recruiting
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Other recruiting trials for Lymphoma, Large B-Cell, Diffuse
Currently open trials in the same condition.
- NCT06890884 — A Clinical Study of Zilovertamab Vedotin (MK-2140) Plus Rituximab Plus Cyclophosphamide, Doxorubicin, and Prednisone (R- · Phase 2 · recruiting
- NCT06254495 — A Safety Study of PF-08046044/SGN-35C in Adults With Advanced Cancers · Phase 1 · active not recruiting
- NCT06093841 — Relmacabtagene Autoleucel As Second-Line Therapy in Adult Patients with Aggressive B-cell NHL · Phase 2 · active not recruiting
- NCT05800366 — A Phase II Study of Glofitamab Plus Polatuzumab-R-CHP for Patients With High-risk Diffuse Large B-cell Lymphoma · Phase 2 · recruiting
- NCT05798156 — Rituximab in Combination With Glofitamab and Polatuzumab Vedotin in Patients With Previously Untreated Aggressive B-cell · Phase 2 · active not recruiting
Other Hoffmann-La Roche trials
Trials by the same sponsor.
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- NCT07059273 — A COPD Data Registry for Participants With Frequent Exacerbations · not yet recruiting
- NCT07416526 — A Clinical Study to Evaluate the Effects of NXT007 Compared to Factor VIII Prophylaxis in Participants With Hemophilia A · Phase 3 · recruiting
- NCT05199688 — A Study To Evaluate Pharmacokinetics, Efficacy, Safety, Tolerability, And Pharmacodynamics Of Satralizumab In Pediatric · Phase 3 · 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 NCT04790903 (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 Hoffmann-La Roche
- Last refreshed: 11 July 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/NCT04790903.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing