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

NCT01523860 | Completed Phase 2

• 1 other identifier: IIL_FLE09
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 37

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

Outcome Measures

Primary Outcomes (1)

• Complete Response (CR) Rate at the end of the consolidation phase

  Proportion of CR according to the Cheson 2007 response criteria

  6 months

Secondary Outcomes (5)

• Progression-free survival (PFS)

  24 months

• Molecular response rate (Bcl2/IgH rearrangement)

  24 months

• Molecular relapse rate

  24 moths

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

  24 months

• Overall survival (OS)

  24 moths

Study Arms (1)

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.

Drug: Rituximab, Mitoxantrone, Bendamustine

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

1

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Italiana Linfomi - ETS: lead
• Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte: collaborator

Study Sites (37)

Divisione di Ematologia Ospedale SS. Antonio e Biagio

Alessandria, Alessandria, 15100, Italy

Location

SOS Ematologia Ospedale C. Massaia

Asti, Asti, 14100, Italy

Location

Ematologia con Trapianto, Università di Bari

Bari, Bari, 70124, Italy

Location

Medicina Interna, Ospedale degli Infermi

Biella, Biella, 13800, Italy

Location

Istituto di Ematologia ed Oncologia Medica A. Seragnoli Policlinico S. Orsola

Bologna, Bologna, 40138, Italy

Location

Divisione di Ematologia e TMO, Ospedale di Bolzano

Bolzano, Bolzano, 39100, Italy

Location

S.C. di Ematologia, Spedali Civili

Brescia, Brescia, 25123, Italy

Location

Divisione di Ematologia, Ospedale Businco

Cagliari, Cagliari, 09121, Italy

Location

Divisione di Ematologia, Ospedale di Catania

Catania, Catania, Italy

Location

Azienda Ospedaliera Santa Croce e Carle

Cuneo, Cuneo, 12100, Italy

Location

Clinica Ematologica Policlinico Carreggi

Florence, Firenze, 50134, Italy

Location

Divisione di Ematologia, Policlinico Careggi

Florence, Firenze, Italy

Location

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.)

Meldola, Forlì-Cesena, 47014, Italy

Location

Ematologia I, A.O.U. San Martino

Genova, Genova, 16132, Italy

Location

Ematologia e Trapianto Ospedale Card.Panico

Tricase, Lecce, Italy

Location

S.C. Ematologia, Azienda Ospedaliera Papardo

Messina, Messina, 98158, Italy

Location

Divisione di Ematologia, Ospedale Niguarda

Milan, Milano, 20162, Italy

Location

Ematologia e Trapianto IRCCS, Istituto Nazionale dei Tumori

Milan, Milano, Italy

Location

Policlinico La Marcora

Milan, Milano, Italy

Location

Ematologia, A.O. San Gerardo

Monza, Milano, 20052, Italy

Location

Oncologia Medica ed Ematologia, Istituto Clinica Humanitas

Rozzano, Milano, 20089, Italy

Location

UO Ematologia, II Facoltà di Medicina e Chirurgia Università Federico II

Napoli, Napoli, 80131, Italy

Location

SCDU Ematologia, AOU Maggiore della Carità

Novara, Novara, 28100, Italy

Location

UO Ematologia, Università - Policlinico San Matteo

Pavia, Pavia, 27100, Italy

Location

Divisione di Oncologia Medica A, Centro di Riferimento Oncologico

Aviano, Pordenone, 33081, Italy

Location

Ematologia Ospedale Santa Maria delle Croci

Ravenna, Ravenna, 48100, Italy

Location

Div. Ematologia A.O. "Bianchi Melacrino Morelli"

Reggio Calabria, Reggio Calabria, 89100, Italy

Location

UO Oncologia ed Onco-Ematologia, Ospedale di Rimini

Rimini, Rn, Italy

Location

Università Cattolica del Sacro Cuore

Roma, Roma, 00168, Italy

Location

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

Roma, Roma, Italy

Location

Ospedale Santa Maria di Terni

Terni, Terni, 05100, Italy

Location

Osp. San Giovanni Battista - Biologia Molecolare

Torino, Torino, 10126, Italy

Location

Osp. San Giovanni Battista - Ematologia 2

Torino, Torino, 10126, Italy

Location

Ospedale S. Chiara

Trento, Trento, Italy

Location

Ematologia Ospedale Santa Maria Di Ca' Foncello

Treviso, Treviso, 31100, Italy

Location

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

Udine, Udine, 33100, Italy

Location

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

Ivrea, 10015, Italy

Location

Related Publications (1)

• 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.

  PMID: 33476434 DERIVED

MeSH Terms

Conditions

Lymphoma, Follicular

Interventions

Rituximab; Mitoxantrone; Bendamustine Hydrochloride

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Anthraquinones; Anthrones; Anthracenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Quinones; Polycyclic Compounds; Butyrates; Acids, Acyclic; Carboxylic Acids; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Umberto Vitolo, MD

  Azienda Sanitaria Ospedaliera-Universitaria S. Giovanni Battista - TORINO

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2011
• First Posted: February 1, 2012
• Study Start: June 1, 2009
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: March 1, 2016

Record last verified: 2016-02

Locations

IT (37)