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Mantle Cell LymphomaPhase 2R2-BNCT01737177

Bendamustine/Lenalidomide/Rituximab: Combination as a Second-Line Therapy for 1st Relapsed-Refractory MCL

A Phase 2 study testing Bendamustine, Lenalidomide, Rituximab in people with Mantle Cell Lymphoma, run by Fondazione Italiana Linfomi - ETS at 43 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 evaluate the safety and activity of the combination of Bendamustine, Lenalidomide and Rituximab (R2-B) in patients with first relapsed/refractory mantle cell lymphoma (MCL) and the efficacy and safety of a maintenance treatment with Lenalidomide for 18… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Mantle Cell Lymphoma
What is being tested?
Bendamustine, Lenalidomide, Rituximab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
43 sitesItaly
Study dates
31 Jul 2012to 2 Feb 2017
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient has a diagnosis of MCL according to the WHO classification;
  • Patient age is ≥ 18 years;
  • Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2;
  • Understands and voluntarily signs an informed consent form;
  • Able to adhere to the study visit schedule and other protocol requirements;
  • Patients treated with one prior regimen and relapsed, or refractory to front line therapy; front line consolidation with autologous stem cell transplantation is considered to be part of first line therapy;
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  • Patient has at least one site of measurable nodal disease at baseline ≥ 2.0 cm in the longest transverse diameter as determined by CT scan (MRI is allowed only if CT scan can not be performed). Note: Patients with bone marrow involvement are eligible;
  • Adequate haematological counts: ANC > 1.5 x 109/L and platelet count > 75 x 109/L unless due to bone marrow involvement by MCL;
  • Conjugated bilirubin up to 2 x ULN unless due to liver involvement by MCL;
  • Alkaline phosphatase and transaminases up to 2 x ULN unless due to liver involvement by MCL;
  • Creatinine clearance ≥ 30 ml/min; a dose reduction of Lenalidomide for patients with creatinine clearance ≥ 30 mL/min but < 50 mL/min is planned;
  • Written informed consent was obtained from the patient prior to any study-specific screening procedures;
  • Patient has the ability to swallow capsules or tablets;
  • Life expectancy ≥ 6 months;
  • Disease free of prior malignancies (a part MCL) with the exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast;

Who cannot join

  • Patients who have received an experimental drug or used an experimental medical device within 4 weeks before the planned start of treatment. Concurrent participation in non-treatment studies is allowed, if it will not interfere with participation in this study;
  • Patient has a history of CNS involvement with lymphoma;
  • Patients with previous history of malignancies (a part MCL) ≤ 3 years before study accrual with the exception of currently treated basal cell and squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix;
  • History of clinically relevant liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, rheumatologic, hematologic, psychiatric, or metabolic disturbances;
  • Patient has any other concurrent severe and/or uncontrolled medical condition(s) (e.g., uncontrolled diabetes mellitus, active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol;
  • Creatinine clearance < 30 ml/min;
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  • Patient has a known history of HIV seropositivity;
  • Patient has active HBV hepatitis. The following categories of HBV positive patients but with non evidence of active hepatitis may be considered for the study and treated with R2-B (see also Section 8.1.8):
  • patient is HBsAg + with HBV DNA < 2000 UI/ml (inactive carriers); HBV DNA > 2000 UI/ml is criteria of exclusion;
  • patient is HBsAg - HBsAb +;
  • patient is HBsAg - but HBcAb +
  • Patients with HCV active hepatitis are excluded from the study. Patient with no evidence of active hepatitis and/or advanced chronic liver disease according to liver biopsy or fibro-scan evaluation may be included into the study
  • Patients have received previous treatment with either Bendamustine and/or Lenalidomide.

Trial locations and contacts

43 sites in 1 country.

43 sites in 1 country

Italy43 sites

  • SC Ematologia AO SS. Antonio e Biagio e C. Arrigo

    Alessandria, 15121

  • Clinica di Ematologia AOU Umberto I Ospedali Riuniti

    Ancona, 60100

  • Centro di riferimento Oncologico CRO Aviano

    Aviano, Pordenone, 33081

  • SC Ematologia Spedali Civili

    Brescia, 25123

  • Ematologia Ospedale Cardarelli ASREM

    Campobasso, 86100

  • Oncoematologia Ospedale SS. Anna e Sebastiano

    Caserta, 81100

  • UOC Ematologia Osp. Garibaldi Nesima

    Catania, 95100

  • Azienda Ospedaliera Pugliese Ciaccio Dipartimento oncoematologico

    Catanzaro, 88100

  • Clinica Ematologica AOU San Martino

    Genova, 16132

  • Ematologia AOU S. Martino - IST

    Genova, 16132

  • UOC Ematologia Universitaria Polo Pontino Sapienza

    Latina, 04100

  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori IRST Meldola

    Meldola, Forlì Cesena, 47014

  • SC Ematologia Azienda Ospedali Riuniti Papardo Piemonte

    Messina, 98100

  • UOC Ematologia Policlinico Universitario AOU G. Martino

    Messina

  • SC Ematologia - Trapianto di midollo osseo Fond. IRCCS Istituto Nazionale Tumori

    Milan, 20133

  • SC Ematologia AO Niguarda Cà Granda

    Milan, 20162

  • SCDU Ematologia - Università del Piemonte Orientale

    Novara, 28100

  • Medicina Interna 2 ad indirizzo Ematologico AOU San Luigi Gonzaga

    Orbassano, Torino, 10043

  • Divisione di Ematologia, Azienda Ospedali Riuniti Villa Sofia Cervello

    Palermo, 90146

  • U.O. Complessa di Ematologia Ospedale di Parma

    Parma, 43100

  • Ematologia Policlinico San Matteo

    Pavia, 27100

  • Unità Ematologia Ospedale Civile di Piacenza

    Piacenza, 29100

  • UO Ematologia Az Ospedaliera Pisana Ospedale "S.Chiara"

    Pisa, 56100

  • UO Ematologia Ospedale Santa Maria delle Croci

    Ravenna, 48100

  • Divisione di Ematologia AO Bianchi Melacrino Morelli

    Reggio Calabria, 89124

  • SC Ematologia AO Santa Maria Nuova IRCCS

    Reggio Emilia, 42123

  • UO Oncoematologia ospedale degli Infermi

    Rimini, 47900

  • IRCCS-Centro di Riferimento Oncologico UO di Ematologia e Trapianto Cellule Staminali

    Rionero in Vulture, Potenza, 85028

  • Ematologia Ospedale San Eugenio

    Roma, 00144

  • UOC Ematologia e Trapianto Istituto Regina Elena (IFO)

    Roma, 00144

  • Ematologia Ospedale S.Camillo Forlanini

    Roma, 00149

  • Ematologia Università La Sapienza

    Roma, 00161

  • UOC Ematologia AO San Giovanni Addolorata

    Roma, 00184

  • Ematologia Istituto Clinico Humanitas

    Rozzano, Milano, 20089

  • Ematologia e Trapianti A.O. San Giovanni di DIO e Ruggi D'Aragona

    Salerno, 84131

  • Ematologia Ospedale SG Moscati

    Taranto, 74100

  • SC Oncoematologia con autotrapianto AO Santa Maria

    Terni, 05100

  • SC Ematologia - AO Città della Salute e della Scienza

    Torino, 10126

  • SC Ematologia U - AO Città della Salute e della Scienza

    Torino, 10126

  • UOC Ematologia Trani

    Trani, Barletta-Andria-Trani (BT), 76125

  • Clinica Ematologica ASUI Integrata di Udine

    Udine, 33100

  • Oncologia Medica Varese Ospedale di Circolo e Fondazione Macchi

    Varese, 21100

  • UO Ematologia Ospedale di Circolo e Fondazione Macchi

    Varese, 21100

Other trials in Italy

About this study

Official title: Bendamustine, Lenalidomide and Rituximab (R2-B) Combination as a Second-Line Therapy for First Relapsed-Refractory Mantle Cell Lymphomas: A Phase II Study

This is a prospective, multicenter phase II trial designed to evaluate the safety and activity of the combination of Bendamustine, Lenalidomide and Rituximab (R2-B) in patients with first relapsed/refractory mantle cell lymphoma (MCL) and the efficacy and safety of a maintenance treatment with Lenalidomide for 18 months from the end of R2-B (from month 7 to 24) for those responding to the induction.

Read the detailed description

This is a phase II study, non randomized, multicenter. Patients with MCL refractory to front line therapy or in first relapse will be enrolled.

The study includes an induction phase, a consolidation phase, a maintenance phase and a follow up phase.

Being tested
Bendamustine, Lenalidomide, Rituximab
Keywords
MCL, Mantle Cell Lymphoma, RELAPSED-REFRACTORY
Medical subject headings
Lymphoma, Mantle-Cell

What participants receive

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

  • Bendamustine, Lenalidomide, RituximabDrug

    INDUCTION PHASE (COURSE 1-4)

    • Bendamustine: 70 mg/m2 on day 2 and 3 every 28
    • Lenalidomide: 10 mg/daily on day 1 to 14 of a 28 days course
    • Rituximab: 375 mg/m2 on day 1 every 28 days; only for the first cycle in the induction phase will start on day 8

    CONSOLIDATION PHASE (courses 5-6)

    Patients in CR and PR at the end of the induction phase

    • Lenalidomide: 15 mg/daily on day 1 to 21 of a 28 days course.
    • Rituximab: 375 mg/m2 on day 1 every 28 days

    MAINTENANCE PHASE (courses 7-24)

    Patients in CR or PR at the end of the consolidation treatment with Lenalidomide until disease progression or unacceptable toxicity up to 18 months (from month 7 to month 24)

    • Lenalidomide: 15 mg/daily on day 1 to 21 of a 28 days
Study groups in NCT01737177
Study groupRoleWhat they receive
Bendamustina, Lenalidomide, RituximabExperimental1 arm for all patients
Receives: Drug: Bendamustine, Lenalidomide, Rituximab

What is being measured

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

  1. Complete Response (CR) rate

    Proportion of CR according to the Cheson2007 response criteria

    Measured: At the end of the consolidation phase (6 months)

  2. Maintenance Progression Free Survival (maPFS)

    maPFS will be defined in the maintenance cohort as the time between the date of CR/PR and the date of disease progression or death from any cause.

    Measured: 36 months

Secondary outcomes (9)

  1. Toxicity

    Incidence of grade 3 or higher Toxicity measured by CTCAE v.4 during induction and maintenance therapy

    Measured: 24 months

  2. Overall Response Rate (ORR)

    ORR at the end of the consolidation treatment is defined as Complete Response(CR) or Partial Response according to the Cheson 2007 response criteria

    Measured: at the end of the consolidation phase (6 months)

  3. Progression Free Survival (PFS) in all patients

    PFS will be measured from the day of enrolment and of disease progression or death from any cause

    Measured: 42 months

  4. Overall Survival (OS)

    OS will be defined as the date of enrolment and the date of recurrence/disease progression or death from any cause

    Measured: 36 months

  5. Molecular response rate

    rate of conversion to molecular remission measured by PCR

    Measured: 24 months

  6. Molecular relapse rate during study period

    rate of conversion to molecular relapse measured by PCR

    Measured: 42 months

  7. Disease kinetics of minimal residual disease (MRD) during study period

    measured by real time PCR in the bone marrow and peripheral blood

    Measured: up to 42 months

  8. Cumulative incidence of second primary malignancies

    incidence of any second primary malignancies (haematological and not haematological) diagnosed after the conclusion of induction phase

    Measured: up to 42 months

  9. To evaluate the possible relationship between Cereblon expression and response to therapy

    Possible relationship between Cereblon expression and response to therapy

    Measured: 6 months

Timeline

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

  1. First posted29 Nov 2012 (estimated)
  2. Study start31 Jul 2012
  3. Primary completionJul 2014
  4. Study completion2 Feb 2017

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
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01737177
Sponsor's protocol ID
FIL R2-B
Acronym
R2-B
Status last verified
Mar 2018
First submitted
27 Nov 2012
Last updated
9 Mar 2018
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bendamustine, Lenalidomide, Rituximab in people with Mantle Cell Lymphoma, run by Fondazione Italiana Linfomi - ETS at 43 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 15 inclusion and 13 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 9 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 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 (time frame: At the end of the consolidation phase (6 months)). The study lists 2 primary outcomes in all. 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 NCT01737177.

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 9 Mar 2018.

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