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Follicular LymphomaPhase 2FLE09NCT01523860

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

A Phase 2 study testing Rituximab, Mitoxantrone, Bendamustine in people with Follicular Lymphoma, run by Fondazione Italiana Linfomi - ETS at 37 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 to 80 years
Conditions the study is for
Follicular Lymphoma
What is being tested?
Rituximab, Mitoxantrone, Bendamustine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
76 participants
Where
37 sitesItaly
Study dates
Jun 2009to Jan 2015
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 to 80 years
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

37 sites in 1 country.

37 sites in 1 country

Italy37 sites

  • Divisione di Ematologia Ospedale SS. Antonio e Biagio

    Alessandria, Alessandria, 15100

  • SOS Ematologia Ospedale C. Massaia

    Asti, Asti, 14100

  • Divisione di Oncologia Medica A, Centro di Riferimento Oncologico

    Aviano, Pordenone, 33081

  • Ematologia con Trapianto, Università di Bari

    Bari, Bari, 70124

  • Medicina Interna, Ospedale degli Infermi

    Biella, Biella, 13800

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

    Bologna, Bologna, 40138

  • Divisione di Ematologia e TMO, Ospedale di Bolzano

    Bolzano, Bolzano, 39100

  • S.C. di Ematologia, Spedali Civili

    Brescia, Brescia, 25123

  • Divisione di Ematologia, Ospedale Businco

    Cagliari, Cagliari, 09121

  • Divisione di Ematologia, Ospedale di Catania

    Catania, Catania

  • Azienda Ospedaliera Santa Croce e Carle

    Cuneo, Cuneo, 12100

  • Clinica Ematologica Policlinico Carreggi

    Florence, Firenze, 50134

  • Divisione di Ematologia, Policlinico Careggi

    Florence, Firenze

  • Ematologia I, A.O.U. San Martino

    Genova, Genova, 16132

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

    Ivrea, 10015

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

    Meldola, Forlì-Cesena, 47014

  • S.C. Ematologia, Azienda Ospedaliera Papardo

    Messina, Messina, 98158

  • Divisione di Ematologia, Ospedale Niguarda

    Milan, Milano, 20162

  • Ematologia e Trapianto IRCCS, Istituto Nazionale dei Tumori

    Milan, Milano

  • Policlinico La Marcora

    Milan, Milano

  • Ematologia, A.O. San Gerardo

    Monza, Milano, 20052

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

    Naples, Napoli, 80131

  • SCDU Ematologia, AOU Maggiore della Carità

    Novara, Novara, 28100

  • UO Ematologia, Università - Policlinico San Matteo

    Pavia, Pavia, 27100

  • Ematologia Ospedale Santa Maria delle Croci

    Ravenna, Ravenna, 48100

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

    Reggio Calabria, Reggio Calabria, 89100

  • UO Oncologia ed Onco-Ematologia, Ospedale di Rimini

    Rimini, Rn

  • Università Cattolica del Sacro Cuore

    Roma, Roma, 00168

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

    Roma, Roma

  • Oncologia Medica ed Ematologia, Istituto Clinica Humanitas

    Rozzano, Milano, 20089

  • Ospedale Santa Maria di Terni

    Terni, Terni, 05100

  • Osp. San Giovanni Battista - Biologia Molecolare

    Torino, Torino, 10126

  • Osp. San Giovanni Battista - Ematologia 2

    Torino, Torino, 10126

  • Ospedale S. Chiara

    Trento, Trento

  • Ematologia Ospedale Santa Maria Di Ca' Foncello

    Treviso, Treviso, 31100

  • Ematologia e Trapianto Ospedale Card.Panico

    Tricase, Lecce

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

    Udine, Udine, 33100

Other trials in Italy

About this study

Official title: 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.

Being tested
Rituximab, Mitoxantrone, Bendamustine
Medical subject headings
Lymphoma, Follicular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rituximab, Mitoxantrone, BendamustineDrug

    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

Study groups in NCT01523860
Study groupRoleWhat they receive
1ExperimentalRituximab 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.
Receives: Drug: Rituximab, Mitoxantrone, Bendamustine

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Proportion of CR according to the Cheson 2007 response criteria

    Measured: 6 months

Secondary outcomes (5)

  1. Progression-free survival (PFS)

    PFS will be measured from the day of enrolment to the date of disease progression, relapse or death due to any cause.

    Measured: 24 months

  2. Molecular response rate (Bcl2/IgH rearrangement)

    Rate of conversion to molecular remission by qualitative and quantitative PCR only in patients with a positive marker at baseline

    Measured: 24 months

  3. Molecular relapse rate

    Rate of conversion to molecular relapse measured by PCR only in patients with a positive marker at baseline

    Measured: 24 moths

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

    Measured: 24 months

  5. Overall survival (OS)

    OS will be measured from the day of enrolment to the date of death due to any cause.

    Measured: 24 moths

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Feb 2012 (estimated)
  2. Study startJun 2009
  3. Primary completionJan 2015
  4. Study completionJan 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
76 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01523860
Sponsor's protocol ID
IIL_FLE09
Acronym
FLE09
Status last verified
Feb 2016
First submitted
23 Jun 2011
Last updated
1 Mar 2016
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 33476434

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Rituximab, Mitoxantrone, Bendamustine in people with Follicular Lymphoma, run by Fondazione Italiana Linfomi - ETS at 37 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete Response (CR) Rate at the end of the consolidation phase (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01523860, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2016.

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