Brief Chemoimmunotherapy With R+B+M Followed by R in Elderly Patients Advanced Stage Untreated Follicular Lymphoma (FLE09)

February 29, 2016 updated by: Fondazione Italiana Linfomi ONLUS

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Alessandria, Italy, 15100
        • Divisione di Ematologia Ospedale SS. Antonio e Biagio
      • Asti, Italy, 14100
        • SOS Ematologia Ospedale C. Massaia
      • Bari, Italy, 70124
        • Ematologia con Trapianto, Università di Bari
      • Biella, Italy, 13800
        • Medicina Interna, Ospedale degli Infermi
      • Bologna, Italy, 40138
        • Istituto di Ematologia ed Oncologia Medica A. Seragnoli Policlinico S. Orsola
      • Bolzano, Italy, 39100
        • Divisione di Ematologia e TMO, Ospedale di Bolzano
      • Brescia, Italy, 25123
        • S.C. di Ematologia, Spedali Civili
      • Cagliari, Italy, 09121
        • Divisione di Ematologia, Ospedale Businco
      • Catania, Italy
        • Divisione di Ematologia, Ospedale di Catania
      • Cuneo, Italy, 12100
        • Azienda Ospedaliera Santa Croce E Carle
      • Firenze, Italy
        • Divisione di Ematologia, Policlinico Careggi
      • Firenze, Italy, 50134
        • Clinica Ematologica Policlinico Carreggi
      • Genova, Italy, 16132
        • Ematologia I, A.O.U. San Martino
      • Ivrea, Italy, 10015
        • S.C. Medicina Trasfusionale ed Ematologia , P.O. Ivrea
      • Messina, Italy, 98158
        • S.C. Ematologia, Azienda Ospedaliera Papardo
      • Milano, Italy
        • Ematologia e Trapianto IRCCS, Istituto Nazionale dei Tumori
      • Milano, Italy, 20162
        • Divisione di Ematologia, Ospedale Niguarda
      • Milano, Italy
        • Policlinico La Marcora
      • Napoli, Italy, 80131
        • UO Ematologia, II Facoltà di Medicina e Chirurgia Università Federico II
      • Novara, Italy, 28100
        • SCDU Ematologia, AOU Maggiore della Carità
      • Pavia, Italy, 27100
        • UO Ematologia, Università - Policlinico San Matteo
      • Ravenna, Italy, 48100
        • Ematologia Ospedale Santa Maria delle Croci
      • Reggio Calabria, Italy, 89100
        • Div. Ematologia A.O. "Bianchi Melacrino Morelli"
      • Roma, Italy, 00168
        • Universita Cattolica del Sacro Cuore
      • Roma, Italy
        • Dipartimento di biotecnologie cellulari ed ematologia Ospedale Umberto I, Università La Sapienza
      • Terni, Italy, 05100
        • Ospedale Santa Maria di Terni
      • Torino, Italy, 10126
        • Osp. San Giovanni Battista - Biologia Molecolare
      • Torino, Italy, 10126
        • Osp. San Giovanni Battista - Ematologia 2
      • Trento, Italy
        • Ospedale S. Chiara
      • Treviso, Italy, 31100
        • Ematologia Ospedale Santa Maria Di Ca' Foncello
      • Udine, Italy, 33100
        • Clinica di Ematologia, A.O.U. di Udine
    • Forlì-Cesena
      • Meldola, Forlì-Cesena, Italy, 47014
        • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.)
    • Lecce
      • Tricase, Lecce, Italy
        • Ematologia e Trapianto Ospedale Card.Panico
    • Milano
      • Monza, Milano, Italy, 20052
        • Ematologia, A.O. San Gerardo
      • Rozzano, Milano, Italy, 20089
        • Oncologia Medica ed Ematologia, Istituto Clinica Humanitas
    • Pordenone
      • Aviano, Pordenone, Italy, 33081
        • Divisione di Oncologia Medica A, Centro di Riferimento Oncologico
    • Rn
      • Rimini, Rn, Italy
        • UO Oncologia ed Onco-Ematologia, Ospedale di Rimini

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 80 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS)
Time Frame: 24 months
PFS will be measured from the day of enrolment to the date of disease progression, relapse or death due to any cause.
24 months
Molecular response rate (Bcl2/IgH rearrangement)
Time Frame: 24 months
Rate of conversion to molecular remission by qualitative and quantitative PCR only in patients with a positive marker at baseline
24 months
Molecular relapse rate
Time Frame: 24 moths
Rate of conversion to molecular relapse measured by PCR only in patients with a positive marker at baseline
24 moths
Incidence of grade 3 or greater overall toxicities measured by CTCAE v.3.0
Time Frame: 24 months
24 months
Overall survival (OS)
Time Frame: 24 moths
OS will be measured from the day of enrolment to the date of death due to any cause.
24 moths

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Italiana Linfomi ONLUS

Collaborators

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

Investigators

  • Study Director: Umberto Vitolo, MD, Azienda Sanitaria Ospedaliera-Universitaria S. Giovanni Battista - TORINO

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

June 23, 2011

First Submitted That Met QC Criteria

January 30, 2012

First Posted (Estimate)

February 1, 2012

Study Record Updates

Last Update Posted (Estimate)

March 1, 2016

Last Update Submitted That Met QC Criteria

February 29, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIL_FLE09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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