--- title: Brief Chemoimmunotherapy With R+B+M Followed by R in Elderly Patients Advanced Stage Untreated Follicular Lymphoma nct_id: NCT01523860 overall_status: COMPLETED phase: PHASE2 sponsor: Fondazione Italiana Linfomi - ETS study_type: INTERVENTIONAL primary_condition: Follicular Lymphoma countries: Italy canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01523860.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01523860" ct_last_update_post_date: 2016-03-01 last_seen_at: "2026-05-12T06:55:07.885Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Brief Chemoimmunotherapy With R+B+M Followed by R in Elderly Patients Advanced Stage Untreated Follicular Lymphoma **Official Title:** Brief Induction Chemoimmunotherapy With Rituximab + Bendamustine + Mitoxantrone Followed by Rituximab in Elderly Patients With Advanced Stage Previously Untreated Follicular Lymphoma **NCT ID:** [NCT01523860](https://clinicaltrials.gov/study/NCT01523860) ## Key Facts - **Status:** COMPLETED - **Phase:** PHASE2 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 76 - **Lead Sponsor:** Fondazione Italiana Linfomi - ETS - **Collaborators:** Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte - **Conditions:** Follicular Lymphoma - **Start Date:** 2009-06 - **Completion Date:** 2015-01 - **CT.gov Last Update:** 2016-03-01 ## Brief Summary 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. ## Eligibility - **Minimum age:** 65 Years - **Maximum age:** 80 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` Inclusion Criteria: * Histological proven diagnosis of B-cell CD20+ follicular NHL, grade I, II and IIIa of WHO Classification * Untreated patients with the exception of prior limited radiotherapy * Stage III or IV who require therapy according to SIE and GELF criteria * Stage II with at least one of the following: * Bulky disease (\>7 cm) * LDH \>normal * Systemic symptoms * Beta2-Microglobulin \>3 mg/l * Extra-nodal involvement * Active disease with rapid progression 5.Age from 65 to 80 years, geriatric score "FIT" (see Appendix B) 6.Life expectancy \>6 months 7.ECOG performance status 0-2 (see Appendix C) 8.LVEF ≥45% or FS ≥37% 9.ANC ≥1 x 109/l and Platelets count ≥75 x 109/l, unless due to bone marrow involvement by follicular lymphoma 10.Creatinine up to 1.5 x ULN 11.Conjugated bilirubin up to 2 x ULN 12.Alkaline phosphatase and transaminases up to 2 x ULN 13.Sending of bone marrow sample for Bcl-2/IgH rearrangement evaluation 14.Written informed content Exclusion Criteria: * Men not agreeing to take adequate contraceptive precautions during and for at least 6 months after cessation of therapy * History of other malignancies within 3 years prior to study entry except for: adequately treated carcinoma in situ of the cervix; basal or squamous cell skin cancer; low grade, early stage, localized prostate cancer treated surgically with curative intent; good prognosis DCIS of the breast treated with lumpectomy alone with curative intent * Medical condition requiring long term use (\>1 months) of systemic corticosteroids * Active bacterial, viral, or fungal infection requiring systemic therapy 5. Concurrent medical condition which might exclude administration of therapy * Cardiac insufficiency (NYHA grade III/IV; see Appendix D) * Myocardial infarction within 6 months of entry on study * Severe chronic obstructive pulmonary disease with hypoxemia * Severe diabetes mellitus difficult to control with adequate insulin therapy * Hypertension that is difficult to control * Impaired renal function with creatinine clearance \<30 ml/min (see Appendix E) * HIV positivity * HBV positivity with the exception of patients HbsAg negative and Ab anti-Hbcore positive (these patients need to receive prophylaxis with Lamivudine) * HCV positivity with the exception of patients with no laboratory signs of active chronic hepatitis and HCV-RNA negativity * CNS involvement by lymphoma 16. Participation at the same time in another study in which investigational drugs are used * Known hypersensitivity or anaphylactic reactions to murine antibodies or proteins * Any other co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent ``` ## Arms - **1** (EXPERIMENTAL) — Rituximab will be supplied as 375 mg/sqm for i.v.administration.Mitoxantrone will be supplied as 8 mg/sqm for i.v.administration.Bendamustine will be supplied as 90 mg/sqm for i.v.administration. ## Interventions - **Rituximab, Mitoxantrone, Bendamustine** (DRUG) — Rituximab will be supplied as 375 mg/sqm for i.v.administration.Mitoxantrone will be supplied as 8 mg/sqm for i.v.administration.Bendamustine will be supplied as 90 mg/sqm for i.v.administration ## Primary Outcomes - **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 ## Secondary Outcomes - **Progression-free survival (PFS)** _(time frame: 24 months)_ - **Molecular response rate (Bcl2/IgH rearrangement)** _(time frame: 24 months)_ - **Molecular relapse rate** _(time frame: 24 moths)_ - **Incidence of grade 3 or greater overall toxicities measured by CTCAE v.3.0** _(time frame: 24 months)_ - **Overall survival (OS)** _(time frame: 24 moths)_ ## Locations (37) - Divisione di Ematologia Ospedale SS. Antonio e Biagio, Alessandria, Alessandria, Italy - SOS Ematologia Ospedale C. Massaia, Asti, Asti, Italy - Ematologia con Trapianto, Università di Bari, Bari, Bari, Italy - Medicina Interna, Ospedale degli Infermi, Biella, Biella, Italy - Istituto di Ematologia ed Oncologia Medica A. Seragnoli Policlinico S. Orsola, Bologna, Bologna, Italy - Divisione di Ematologia e TMO, Ospedale di Bolzano, Bolzano, Bolzano, Italy - S.C. di Ematologia, Spedali Civili, Brescia, Brescia, Italy - Divisione di Ematologia, Ospedale Businco, Cagliari, Cagliari, Italy - Divisione di Ematologia, Ospedale di Catania, Catania, Catania, Italy - Azienda Ospedaliera Santa Croce e Carle, Cuneo, Cuneo, Italy - Clinica Ematologica Policlinico Carreggi, Florence, Firenze, Italy - Divisione di Ematologia, Policlinico Careggi, Florence, Firenze, Italy - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.), Meldola, Forlì-Cesena, Italy - Ematologia I, A.O.U. San Martino, Genova, Genova, Italy - Ematologia e Trapianto Ospedale Card.Panico, Tricase, Lecce, Italy - S.C. Ematologia, Azienda Ospedaliera Papardo, Messina, Messina, Italy - Divisione di Ematologia, Ospedale Niguarda, Milan, Milano, Italy - Ematologia e Trapianto IRCCS, Istituto Nazionale dei Tumori, Milan, Milano, Italy - Policlinico La Marcora, Milan, Milano, Italy - Ematologia, A.O. San Gerardo, Monza, Milano, Italy - Oncologia Medica ed Ematologia, Istituto Clinica Humanitas, Rozzano, Milano, Italy - UO Ematologia, II Facoltà di Medicina e Chirurgia Università Federico II, Naples, Napoli, Italy - SCDU Ematologia, AOU Maggiore della Carità, Novara, Novara, Italy - UO Ematologia, Università - Policlinico San Matteo, Pavia, Pavia, Italy - Divisione di Oncologia Medica A, Centro di Riferimento Oncologico, Aviano, Pordenone, Italy - Ematologia Ospedale Santa Maria delle Croci, Ravenna, Ravenna, Italy - Div. Ematologia A.O. "Bianchi Melacrino Morelli", Reggio Calabria, Reggio Calabria, Italy - UO Oncologia ed Onco-Ematologia, Ospedale di Rimini, Rimini, Rn, Italy - Università Cattolica del Sacro Cuore, Roma, Roma, Italy - Dipartimento di biotecnologie cellulari ed ematologia Ospedale Umberto I, Università La Sapienza, Roma, Roma, Italy - Ospedale Santa Maria di Terni, Terni, Terni, Italy - Osp. San Giovanni Battista - Biologia Molecolare, Torino, Torino, Italy - Osp. San Giovanni Battista - Ematologia 2, Torino, Torino, Italy - Ospedale S. Chiara, Trento, Trento, Italy - Ematologia Ospedale Santa Maria Di Ca' Foncello, Treviso, Treviso, Italy - Clinica di Ematologia, A.O.U. di Udine, Udine, Udine, Italy - S.C. Medicina Trasfusionale ed Ematologia , P.O. Ivrea, Ivrea, Italy ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.maxAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `sponsor.collaborators` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.divisione di ematologia ospedale ss. antonio e biagio|alessandria|alessandria|italy` — added _(2026-05-12)_ - `locations.sos ematologia ospedale c. massaia|asti|asti|italy` — added _(2026-05-12)_ - `locations.ematologia con trapianto, università di bari|bari|bari|italy` — added _(2026-05-12)_ - `locations.medicina interna, ospedale degli infermi|biella|biella|italy` — added _(2026-05-12)_ - `locations.istituto di ematologia ed oncologia medica a. seragnoli policlinico s. orsola|bologna|bologna|italy` — added _(2026-05-12)_ - `locations.divisione di ematologia e tmo, ospedale di bolzano|bolzano|bolzano|italy` — added _(2026-05-12)_ - `locations.s.c. di ematologia, spedali civili|brescia|brescia|italy` — added _(2026-05-12)_ - `locations.divisione di ematologia, ospedale businco|cagliari|cagliari|italy` — added _(2026-05-12)_ - `locations.divisione di ematologia, ospedale di catania|catania|catania|italy` — added _(2026-05-12)_ - `locations.azienda ospedaliera santa croce e carle|cuneo|cuneo|italy` — added _(2026-05-12)_ - `locations.clinica ematologica policlinico carreggi|florence|firenze|italy` — added _(2026-05-12)_ - `locations.divisione di ematologia, policlinico careggi|florence|firenze|italy` — added _(2026-05-12)_ - `locations.istituto scientifico romagnolo per lo studio e la cura dei tumori (i.r.s.t.)|meldola|forlì-cesena|italy` — added _(2026-05-12)_ - `locations.ematologia i, a.o.u. san martino|genova|genova|italy` — added _(2026-05-12)_ - `locations.ematologia e trapianto ospedale card.panico|tricase|lecce|italy` — added _(2026-05-12)_ - `locations.s.c. ematologia, azienda ospedaliera papardo|messina|messina|italy` — added _(2026-05-12)_ - `locations.divisione di ematologia, ospedale niguarda|milan|milano|italy` — added _(2026-05-12)_ - `locations.ematologia e trapianto irccs, istituto nazionale dei tumori|milan|milano|italy` — added _(2026-05-12)_ - `locations.policlinico la marcora|milan|milano|italy` — added _(2026-05-12)_ - `locations.ematologia, a.o. san gerardo|monza|milano|italy` — added _(2026-05-12)_ - `locations.oncologia medica ed ematologia, istituto clinica humanitas|rozzano|milano|italy` — added _(2026-05-12)_ - `locations.uo ematologia, ii facoltà di medicina e chirurgia università federico ii|naples|napoli|italy` — added _(2026-05-12)_ - `locations.scdu ematologia, aou maggiore della carità|novara|novara|italy` — added _(2026-05-12)_ - `locations.uo ematologia, università - policlinico san matteo|pavia|pavia|italy` — added _(2026-05-12)_ - `locations.divisione di oncologia medica a, centro di riferimento oncologico|aviano|pordenone|italy` — added _(2026-05-12)_ - `locations.ematologia ospedale santa maria delle croci|ravenna|ravenna|italy` — added _(2026-05-12)_ - `locations.div. ematologia a.o. 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