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NCT01523860: FLE09
Brief Induction Chemoimmunotherapy With Rituximab + Bendamustine + Mitoxantrone Followed by Rituximab in Elderly Patients With Advanced Stage Previously Untreated Follicular Lymphoma
Phase 2 trial testing Rituximab, Mitoxantrone, Bendamustine in Follicular Lymphoma in 76 participants. Completed in 1 January 2015.
1 January 2015
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 | 76 |
| Start date | 1 June 2009 |
| Primary completion | 1 January 2015 |
| Estimated completion | 1 January 2015 |
| Sites | 37 locations across Italy |
Drugs / interventions tested
- Rituximab, Mitoxantrone, Bendamustine — full drug profile →
Conditions studied
- Follicular Lymphoma — all drugs for Follicular Lymphoma →
Sponsor
Fondazione Italiana Linfomi - ETS — full company profile →
Who can join
Adults 65 to 80, any sex, with Follicular Lymphoma. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Complete Response (CR) Rate at the end of the consolidation phase
Time frame: 6 months
Proportion of CR according to the Cheson 2007 response criteria
Sponsor's own description
This is a prospective, multicenter phase II trial designed to determine efficacy and safety of a brief chemoimmunotherapy with the combination of Rituximab + Bendamustine + Mitoxantrone in elderly patients with advanced stage Follicular Lymphoma.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Advances in Lipid-Based Nanoparticles for Cancer Chemoimmunotherapy.
Wang T, Suita Y, Miriyala S, Dean J, et al · · 2021 · cited 33× · PMID 33918635 · DOI 10.3390/pharmaceutics13040520
Verify or expand the search:
- PubMed search for NCT01523860
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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 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 NCT01523860 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 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: 29 February 2016
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/NCT01523860.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing