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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte
Information provided by (Responsible Party):
Fondazione Italiana Linfomi ONLUS
ClinicalTrials.gov Identifier:
NCT01523860
First received: June 23, 2011
Last updated: January 30, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
Follicular Lymphoma
Drug: Rituximab, Mitoxantrone, Bendamustine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Brief Induction Chemoimmunotherapy With Rituximab + Bendamustine + Mitoxantrone Followed by Rituximab in Elderly Patients With Advanced Stage Previously Untreated Follicular Lymphoma

Resource links provided by NLM:


Further study details as provided by Fondazione Italiana Linfomi ONLUS:

Primary Outcome Measures:
  • Complete Response (CR) Rate at the end of the consolidation phase [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Proportion of CR according to the Cheson 2007 response criteria


Secondary Outcome Measures:
  • Progression-free survival (PFS) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    PFS will be measured from the day of enrolment to the date of disease progression, relapse or death due to any cause.

  • Molecular response rate (Bcl2/IgH rearrangement) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Rate of conversion to molecular remission by qualitative and quantitative PCR only in patients with a positive marker at baseline

  • Molecular relapse rate [ Time Frame: 24 moths ] [ Designated as safety issue: No ]
    Rate of conversion to molecular relapse measured by PCR only in patients with a positive marker at baseline

  • Incidence of grade 3 or greater overall toxicities measured by CTCAE v.3.0 [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Overall survival (OS) [ Time Frame: 24 moths ] [ Designated as safety issue: No ]
    OS will be measured from the day of enrolment to the date of death due to any cause.


Estimated Enrollment: 67
Study Start Date: June 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   65 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01523860

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

No publications provided

Responsible Party: Fondazione Italiana Linfomi ONLUS
ClinicalTrials.gov Identifier: NCT01523860     History of Changes
Other Study ID Numbers: IIL_FLE09
Study First Received: June 23, 2011
Last Updated: January 30, 2012
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Follicular
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Mitoxantrone
Bendamustine
Rituximab
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents
Immunologic Factors
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 21, 2014