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

NCT ID: NCT01523860

Last Updated: 2016-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2015-01-31

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.

Conditions

Follicular Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

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.

Group Type: EXPERIMENTAL

Rituximab, Mitoxantrone, Bendamustine

Intervention Type: 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

Interventions

Rituximab, Mitoxantrone, Bendamustine

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte

OTHER

Sponsor Role: collaborator

Fondazione Italiana Linfomi - ETS

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Umberto Vitolo, MD

Role: STUDY_DIRECTOR

Azienda Sanitaria Ospedaliera-Universitaria S. Giovanni Battista - TORINO

Locations

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

Napoli, 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

Countries

Italy

References

Boccomini C, Ladetto M, Rigacci L, Puccini B, Rattotti S, Volpetti S, Ferrero S, Chiarenza A, Freilone R, Novo M, Corradini P, Nassi L, Rusconi C, Stelitano C, Bolis S, Marina Liberati A, Tucci A, Baldini L, Balzarotti M, Evangelista A, Ciccone G, Vitolo U. A brief rituximab, bendamustine, mitoxantrone (R-BM) induction followed by rituximab consolidation in elderly patients with advanced follicular lymphoma: a phase II study by the Fondazione Italiana Linfomi (FIL). Br J Haematol. 2021 Apr;193(2):280-289. doi: 10.1111/bjh.17283. Epub 2021 Jan 21.

Reference Type: DERIVED

PMID: 33476434 (View on PubMed)

Other Identifiers

IIL_FLE09

Identifier Type: -

Identifier Source: org_study_id