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NCT03567876
Rituximab, Bendamustine and Cytarabine Followed by Venetoclax in High Risk Elderly Patients With MCL
Phase 2 trial testing Venetoclax in Lymphoma, Mantle-Cell in 141 participants. Completed in 15 October 2025.
26 July 2021
Quick facts
| Lead sponsor | Fondazione Italiana Linfomi - ETS |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 141 |
| Start date | 3 September 2018 |
| Primary completion | 26 July 2021 |
| Estimated completion | 15 October 2025 |
| Sites | 35 locations across Italy |
Drugs / interventions tested
- Venetoclax (venetoclax) — full drug profile →
Conditions studied
- Lymphoma, Mantle-Cell — all drugs for Lymphoma, Mantle-Cell →
Sponsor
Fondazione Italiana Linfomi - ETS — full company profile →
Who can join
18 and older, any sex, with Lymphoma, Mantle-Cell. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Prospective, multicenter, phase II trial designed to evaluate whether the addition of Venetoclax after rituximab, bendamustine and cytarabine (R-BAC) to high risk patients with mantle cell lymphoma improves the results of the standard R-BAC, in terms of Progression Free Survival.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Long-term follow-up of rituximab plus bendamustine and cytarabine in older patients with newly diagnosed MCL.
Tisi MC, Moia R, Patti C, Evangelista A, et al · · 2023 · cited 20× · PMID 37171620 · DOI 10.1182/bloodadvances.2023009744 -
Tipping the balance: toward rational combination therapies to overcome venetoclax resistance in mantle cell lymphoma.
Thus YJ, Eldering E, Kater AP, Spaargaren M. · · 2022 · cited 17× · PMID 35725771 · DOI 10.1038/s41375-022-01627-9 -
Rituximab, bendamustine, and cytarabine followed by venetoclax in older patients with high-risk mantle cell lymphoma (FIL_V-RBAC): a multicentre, single-arm, phase 2 study.
Visco C, Tabanelli V, Sacchi MV, Evangelista A, et al · · 2025 · cited 2× · PMID 40975105 · DOI 10.1016/s2352-3026(25)00252-2 -
<i>TP53</i> Mutations in Mantle Cell Lymphoma: From Backup to Game Changer.
Carazzolo ME, Moioli A, Visco C. · · 2025 · PMID 41375783 · DOI 10.3390/jcm14238480
Verify or expand the search:
- PubMed search for NCT03567876
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Venetoclax
Trials testing the same drug.
- NCT07425808 — FLT3-ITD Targeted Therapy in Fit AML Patients · Phase 2, PHASE3 · not yet recruiting
- NCT07437950 — Comparing Different Treatment Lengths for Venetoclax in Older People With Newly Diagnosed Acute Myeloid Leukemia (A Myel · Phase 2 · not yet recruiting
- NCT07175415 — HEM-iSMART E: Capivasertib + Venetoclax + Dexamethasone in Pediatric Patients With Relapsed or Refractory Hematological · Phase 1, PHASE2 · not yet recruiting
- NCT07513129 — A Phase 1 Study Of Venetoclax, Dexamethasone, Bortezomib, And Daratumumab (VDBD) For Adolescent And Young Adult Patients · Phase 1 · not yet recruiting
- NCT07511062 — Axatilimab Combined With Decitabine/Venetoclax for the Treatment of TP53-mutated AML · Phase 1 · not yet recruiting
Other recruiting trials for Lymphoma, Mantle-Cell
Currently open trials in the same condition.
- NCT06136351 — A Study of the Zanubrutinib Given in Combination With Bendamustine and Rituximab in (Elderly or TP53 Alterations or Chem · Phase 2 · recruiting
- NCT05659732 — A Study of PEP07 (Checkpoint Kinase 1 Inhibitor) in Patients With Advanced Cancer · Phase 1 · recruiting
Other Fondazione Italiana Linfomi - ETS trials
Trials by the same sponsor.
- NCT07453095 — Study With Glofitamab in Patients With MCL and Inadequate Response or Relapse Following CAR T-cell Therapy · Phase 2 · not yet recruiting
- NCT07256158 — PET Guided Dose Reduction for InvOlved Site Radiotherapy In Early sTage Unfavourable Hodgkin Lymphoma · Phase 3 · not yet recruiting
- NCT07207785 — PirtobrUtinib as Frontline Therapy for Elderly Unfit/Frail Patient With MAntle Cell Lymphoma · Phase 2 · not yet recruiting
- NCT06781359 — Study on Plasmablastic Lymphoma Patients · recruiting
- NCT06492837 — Study With Mosunetuzumab and Zanubrutinib in R/R Follicular Lymphoma Patients · Phase 2 · 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 NCT03567876 (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 Fondazione Italiana Linfomi - ETS
- Last refreshed: 8 December 2025
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/NCT03567876.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing