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Brief Chemoimmunotherapy With R+B+M Followed by R in Elderly Patients Advanced Stage Untreated Follicular Lymphoma

Information source: Fondazione Italiana Linfomi ONLUS
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Follicular Lymphoma

Intervention: Rituximab, Mitoxantrone, Bendamustine (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Fondazione Italiana Linfomi ONLUS

Official(s) and/or principal investigator(s):
Umberto Vitolo, MD, Study Director, Affiliation: Azienda Sanitaria Ospedaliera-Universitaria S. Giovanni Battista - TORINO


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.

Clinical Details

Official title: Brief Induction Chemoimmunotherapy With Rituximab + Bendamustine + Mitoxantrone Followed by Rituximab in Elderly Patients With Advanced Stage Previously Untreated Follicular Lymphoma

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Complete Response (CR) Rate at the end of the consolidation phase

Secondary outcome:

Progression-free survival (PFS)

Molecular response rate (Bcl2/IgH rearrangement)

Molecular relapse rate

Incidence of grade 3 or greater overall toxicities measured by CTCAE v.3.0

Overall survival (OS)


Minimum age: 65 Years. Maximum age: 80 Years. Gender(s): Both.


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

Locations and Contacts

Divisione di Ematologia Ospedale SS. Antonio e Biagio, Alessandria 15100, Italy

SOS Ematologia Ospedale C. Massaia, Asti 14100, Italy

Ematologia con Trapianto, Università di Bari, Bari 70124, Italy

Medicina Interna, Ospedale degli Infermi, Biella 13800, Italy

Istituto di Ematologia ed Oncologia Medica A. Seragnoli Policlinico S. Orsola, Bologna 40138, Italy

Divisione di Ematologia e TMO, Ospedale di Bolzano, Bolzano 39100, Italy

S.C. di Ematologia, Spedali Civili, Brescia 25123, Italy

Divisione di Ematologia, Ospedale Businco, Cagliari 09121, Italy

Divisione di Ematologia, Ospedale di Catania, Catania, Italy

Azienda Ospedaliera Santa Croce e Carle, Cuneo 12100, Italy

Clinica Ematologica Policlinico Carreggi, Firenze 50134, Italy

Divisione di Ematologia, Policlinico Careggi, Firenze, Italy

Ematologia I, A.O.U. San Martino, Genova 16132, Italy

S.C. Medicina Trasfusionale ed Ematologia , P.O. Ivrea, Ivrea 10015, Italy

S.C. Ematologia, Azienda Ospedaliera Papardo, Messina 98158, Italy

Divisione di Ematologia, Ospedale Niguarda, Milano 20162, Italy

Ematologia e Trapianto IRCCS, Istituto Nazionale dei Tumori, Milano, Italy

Policlinico La Marcora, Milano, Italy

UO Ematologia, II Facoltà di Medicina e Chirurgia Università Federico II, Napoli 80131, Italy

SCDU Ematologia, AOU Maggiore della Carità, Novara 28100, Italy

UO Ematologia, Università - Policlinico San Matteo, Pavia 27100, Italy

Ematologia Ospedale Santa Maria delle Croci, Ravenna 48100, Italy

Div. Ematologia A.O. "Bianchi Melacrino Morelli", Reggio Calabria 89100, Italy

Dipartimento di biotecnologie cellulari ed ematologia Ospedale Umberto I, Università La Sapienza, Roma, Italy

Università Cattolica del Sacro Cuore, Roma 00168, Italy

Ospedale Santa Maria di Terni, Terni 05100, Italy

Osp. San Giovanni Battista - Biologia Molecolare, Torino 10126, Italy

Osp. San Giovanni Battista - Ematologia 2, Torino 10126, Italy

Ospedale S. Chiara, Trento, Italy

Ematologia Ospedale Santa Maria Di Ca' Foncello, Treviso 31100, Italy

Clinica di Ematologia, A.O.U. di Udine, Udine 33100, Italy

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.), Meldola, Forlì-Cesena 47014, Italy

Ematologia e Trapianto Ospedale Card.Panico, Tricase, Lecce, Italy

Ematologia, A.O. San Gerardo, Monza, Milano 20052, Italy

Oncologia Medica ed Ematologia, Istituto Clinica Humanitas, Rozzano, Milano 20089, Italy

Divisione di Oncologia Medica A, Centro di Riferimento Oncologico, Aviano, Pordenone 33081, Italy

UO Oncologia ed Onco-Ematologia, Ospedale di Rimini, Rimini, Rn, Italy

Additional Information

Starting date: June 2009
Last updated: January 30, 2012

Page last updated: August 23, 2015

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