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MANTLE CELL LYMPHOMAPhase 3MCL0208NCT02354313

Phase III, Randomized Trial: Lenalidomide vs Observation After Induction With Rituximab Followed by Cht and ASCT in MCL Adult Patients

A Phase 3 study testing Lenalidomide in people with MANTLE CELL LYMPHOMA, run by Fondazione Italiana Linfomi - ETS at 53 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

A phase III multicenter, randomized study with Lenalidomide (Revlimid®) maintenance versus observation after intensified induction regimen containing rituximab followed by high dose chemotherapy and Autologous Stem Cell Transplantation as first line treatment in adult patients with advanced Mantle Cell Lymphoma: IIL… Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
MANTLE CELL LYMPHOMA
What is being tested?
Lenalidomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
53 sitesin 2 countries
Study dates
May 2010to Jan 2019
Phase
Phase 3
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 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Any male or female adult with newly diagnosed mantle cell lymphoma according to the WHO criteria.
  • Biopsy-proven mantle cell non-Hodgkin's lymphoma, including evidence of cyclin D1 overexpression or the translocation t(11;14)(q13;q32) by FISH or RT-PCR. In subjects whose tumors are negative for the cyclin D1, evidence of overexpression of cyclin D2 or D3 by immunohistochemistry will be acceptable.
  • Age ≥18 years and < 60 with ECOG performance status 0-3, or an age from 60 to 65 years with an ECOG performance status 0-2, except when PS impairment is related to NHL.
  • Advanced stage (Stage III and IV according to Ann Arbor and stage II with bulky disease defined as a mass ≥ 5 cm or B symptoms).
  • Measurable disease (two diameters) in at least one site. Osteoblastic bone lesions, ascites and pleural effusion are not considered measurable disease.
  • Written informed consent prior to any study specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.
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  • Be willing and able to comply with the protocol for the duration of the study.
  • Females of childbearing potential (FCBP) must: have two negative medically supervised pregnancy test prior to starting of study therapy. She must agree to ongoing pregnancy testing during the course of the study, and after end of study therapy. This applies even if the patient practices complete and continued sexual abstinence. Either commit to continued abstinence from heterosexual intercourse (which must be reviewed on a monthly basis) or agree to use, and be able to comply with, effective contraception without interruption, 28 days prior to starting study drug, during the study therapy (including dose interruptions), and for 28 days after discontinuation of study therapy. The following are effective methods of contraception
  • Implant
  • Levonorgestrel-releasing intrauterine system (IUS)
  • Medroxyprogesterone acetate depot
  • Tubal sterilisation
  • Sexual intercourse with a vasectomised male partner only; vasectomy must be confirmed by two negative semen analyses
  • Ovulation inhibitory progesterone-only pills (i.e., desogestrel)
  • Male patients must agree to use a condom during sexual contact with a FCBP, even if they have had a vasectomy, throughout study drug therapy, during any dose interruption and after cessation of study therapy. Agree to not donate semen during study drug therapy and for a period after end of study drug therapy.
  • All patients must have an understanding that the study drug could have a potential teratogenic risk. They must agree to abstain from donating blood while taking study drug therapy and following discontinuation of study drug therapy. They must to agree not to share study medication with another person. They must be counseled about pregnancy precautions and risks of fetal exposure.

Who cannot join

  • Non-Hodgkin's lymphoma subtypes other than MCL
  • Cytological variant with small cells with round nuclei mimicking CLL, which is frequently recognized in patients with a leukemic and splenomegaly presentation without or with minimal involvement of lymph nodes and has an indolent clinical course.
  • History of malignancy other than squamous cell carcinoma, basal cell carcinoma of the skin or carcinoma in situ of the cervix, carcinoma in situ of the breast, incidental histological finding of prostate cancer (TNM stage of T1a or T1b) within the last 3 years.
  • Major surgery, other than diagnostic surgery, within the last 4 weeks.
  • Evidence of CNS involvement, patients with an history of uncontrolled seizures, central nervous system disorders or psychiatric disability considered by the Investigator to be clinically significant and adversely affecting compliance to study drugs. If clinically indicated, lumbar puncture, and MRI should be performed during the screening process.
  • Clinically significant cardiac disease (VEF <45%) (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 6 months (New York Heart Association Class III or IV heart disease) and marked impairment of pulmonary function (pulmonary diffusing capacity <50%).
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  • Unacceptable hematologic values in the week prior to the start of study: hemoglobin <9 g/dL, WBC <3x109/L, platelets <60x109/L, absolute neutrophil count (ANC)<1.5x109/L (unless cytopenia is secondary to bone marrow involvement or autoimmune cytopenia related to lymphoma).
  • Abnormal liver function tests, within one week prior to study start above any of the values listed: serum bilirubin > 2 mg/dL, ALT or AST >3 times the upper normal value; alkaline phosphatase>2.5 times the upper normal value (unless these abnormalities are due to liver involvement of lymphoma).
  • Abnormal renal function (serum creatinine >2.0 mg/dL), unless it is disease related
  • Patients with active opportunistic infections.
  • Known seropositive for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). Patients who are seropositive because of hepatitis B virus vaccine are eligible. Patients with HBcAb serology, will not be excluded from the study and be given lamivudine as prophylaxis starting one week before chemotherapy. HbsAg and AST/ALT ifHBV DNA is not available, will be monitored every three weeks. If HBV DNA is available, it will be monitored along with HBsAg
  • Pregnant or lactating females

Trial locations and contacts

53 sites in 2 countries.

53 sites in 2 countries

Italy52 sites

  • SC Ematologia A.O.SS. Biagio e Antonio e C. Arrigo

    Alessandria

  • AORN San G.Moscati

    Avellino

  • Centro di riferimento Oncologico - Oncologia Medica A

    Aviano (PN)

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

    Bologna, 40138

  • Divisione di Ematologia e TMO, Ospedale di Bolzano

    Bolzano, 39100

  • Divisione di Ematologia Spedali Civili

    Brescia

  • Divisione di Ematologia Osp.Businco

    Cagliari

  • IRCC Onco-Ematologia

    Candiolo

  • S.C. di Ematologia e Trapianto di Midollo Osseo ASO S. Croce e Carle

    Cuneo

  • Divisione di Ematologia, Policlinico Careggi

    Florence

  • Ematologia, A.O.U. San Martino

    Genova, 16132

  • Clinica Ematologica, A.O.U. San Martino - IST

    Genova

  • Divisione di Ematologia Ospedale Vito Fazzi

    Lecce

  • Istituto Scientifico Romagnolo per lo studio e la cura dei Tumori-IRST - Meldola / Cesena

    Meldola (FC)

  • Ematologia AO Ospedali Riuniti Papardo-Piemonte

    Messina

  • UO Ematologia Ospedale Dell'Angelo

    Mestre, VE

  • Divisione di Ematologia, Ospedale Niguarda

    Milan, 20162

  • Dipartimento di Ematologia e Oncologia - Ospedale Maggiore Policlinico Mangiagalli e Regina Elena

    Milan

  • Unità Linfomi- Dipartimento Oncoematologia- Istituto Scientifico San Raffaele IRCCS

    Milan

  • Dipartimento di Scienze Mediche UOC di Oncologia ed Ematologia Oncologica - Ospedale di Mirano

    Mirano

  • Dip. di Oncologia ed Ematologia - Università di Modena e Reggio Emilia Policlinico - COM Centro Oncologico Modenese

    Modena

  • Osp.San Gerardo Divisione di Ematologia

    Monza

  • S.C.D.U Ematologia Azienda Ospedaliera Universitaria Maggiore - Università del Piemonte Orientale

    Novara, 28100

  • U.O.C. Ematologia e CTMO Presidio Ospedale S. Francesco

    Nuoro

  • U.O. Oncoematologia Ospedale "Andrea Tortora"

    Pagani

  • Divisione di Ematologia, Azienda Ospedali Riuniti Villa Sofia Cervello

    Palermo

  • Oncoematologia e TMO Clinica "La Maddalena"

    Palermo

  • Cattedra di Ematologia - Centro Trapianti Midollo Osseo - Università Parma

    Parma

  • Fondazione Policlinico San Matteo Clinica Ematologica

    Pavia

  • U.O. Ematologia e Centro Trapianto Midollo Osseo - Ospedale G. da Saliceto

    Piacenza

  • Dipartimento di Oncologia Divisione di Ematologia, Azienda Ospedaliera Pisana Ospedale "S.Chiara"

    Pisa

  • Divisione di Ematologia con TMO - Ospedale San Carlo

    Potenza

  • U.O di Ematologia Ospedale S. Maria delle Croci

    Ravenna

  • Divisione di Ematologia - Presidio Ospedali Riuniti Bianchi, Melacrino, Morelli

    Reggio Calabria

  • S. C. Ematologia - Azienda Ospedaliera Arcispedale - "S.Maria Nuova" IRCCS

    Reggio Emilia

  • UO Ematologia - Ospedale degli Infermi

    Rimini

  • Cattedra di Ematologia Università Cattolica Policlinico Gemelli

    Roma

  • Dipartimento di Biotecnologie Cellulari ed Ematologia Università "La Sapienza"

    Roma

  • Divisione di Ematologia Policlinico Università Tor-Vergata

    Roma

  • Divisione di Oncologia Medica ed Ematologia, Istituto Clinico Humanitas

    Rozzano (MI)

  • Divisione di Ematologia, Centro Trapianto di Cellule Staminali, IRCCS "Casa Sollievo della Sofferenza"

    San Giovanni Rotondo

  • Istituto di Ematologia - Azienda Ospedaliero Universitaria di Sassari

    Sassari

  • Divisione di Ematologia - Policlinico Le Scotte

    Siena

  • Struttura Complessa di Oncoematologia - Ospedale Santa Maria

    Terni

  • S.C.D.U. Ematologia Universitaria A.O. Città della Salute e della Scienza di Torino

    Torino

  • SC. Ematologia A.O. Città della Salute e della Scienza

    Torino

  • Divisione di Ematologia ASL BAT 1

    Trani

  • U.O. Ematologia e Immunoematologia - Ospedale Cà Foncello

    Treviso

  • Divisione di Ematologia Ospedale Cardinale Panico

    Tricase

  • Ematologia Clinica Ospedale Maggiore

    Trieste

  • Clinica Ematologica ASUI Integrata di Udine

    Udine

  • Ospedale Policlinico G.B. Rossi

    Verona

Other trials in Italy

Portugal1 site

  • Departemento de Hematologia di Instituto Português de Oncologia de Lisboa Francisco Gentil

    Lisbon

Other trials in Portugal

About this study

Official title: A Phase III Multicenter, Randomized Study With Lenalidomide Maintenance vs Observation After Induction Regimen Containing Rituximab Followed by High Dose Chemotherapy and ASCT as First Line Treatment in Adult Patients With Advanced Mantle Cell Lymphoma

A phase III multicenter, randomized study with Lenalidomide (Revlimid®) maintenance versus observation after intensified induction regimen containing rituximab followed by high dose chemotherapy and Autologous Stem Cell Transplantation as first line treatment in adult patients with advanced Mantle Cell Lymphoma: IIL study (MCL0208).

Read the detailed description

This is a Phase 3, multicenter, open-label, randomized, controlled study to determine the efficacy and safety of lenalidomide as maintenance therapy versus observation in patients with MCL in complete or partial remission after first line intensified and high-dose chemotherapy additioned with rituximab and followed by ASCT. This study will be conducted in three phases: a Screening Phase, a Treatment Phase and a Follow-up Phase

Being tested
Lenalidomide
Keywords
MANTLE CELL LYMPHOMA (MCL), Lenalidomide (Len), Rituximab, ASCT, Revlimid, High dose chemotherapy, transplant
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.

  • LenalidomideDrug

    Also called Revlimid

    Treatment Phase: consisting in an induction phase (3 cycles of RCHOP, given every 21 days); consolidation phase: (high-dose cyclophosphamide (CTX), 2 cycles of high dose Ara-C, BEAM and ASCT).

    Randomization and maintenance phase: Patients who have achieved complete or partial response will be randomized between maintenance with lenalidomide or observation.

Study groups in NCT02354313
Study groupRoleWhat they receive
LenalidomideExperimentallenalidomide 10-15 mg once daily on days 1-21, every 28 day, for two years
Receives: Drug: Lenalidomide
ObservationNo interventionno therapy is planned but only observation

What is being measured

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

  1. Progression Free Survival (PFS)

    PFS will be defined as the time between the date of randomization and the date of disease progression, relapse or death from any cause.therapy to prolong progression-free survival (PFS) after completion of first-line high-dose chemotherapy additioned with rituximab and followed by ASCT in adult patients with MCL who have achieved complete response (CR) or partial response (PR). PFS is defined according to Cheson et al (JCO, 2007) as the time from randomisation until lymphoma progression or death as a result of any cause.

    Measured: 30 months from randomisation

Secondary outcomes (8)

  1. Overall Survival (OS)

    OS will be defined as the time between the date of randomization and the date of death from any cause

    Measured: 36 months from randomisation (42 months from accrual)

  2. Progression Free Survival (PFS)

    PFS will be defined as the time between the date of enrolment and the date of disease progression, relapse or death from any cause.

    Measured: 36 months from accrual

  3. Disease-free survival (DFS)

    DFS will be defined in CR patients as the time between the date of randomization and the date of relapse or death as a result of lymphoma or acute toxicity of treatment according to the Cheson 2007

    Measured: 30 months from randomisation (36 months from accrual)

  4. Event-free survival (EFS)

    EFS will be defined in CR patients as the time between the date of randomization and the date of failure of treatment or death as a result of any cause according to the Cheson 2007

    Measured: 30 months from randomisation (36 months from accrual)

  5. Complete Response (CR) Rate

    Proportion of CR according to the Cheson 2007 response criteria

    Measured: up to 3 months from accrual

  6. Overall Response Rate (ORR)

    ORR is defined as Complete Response (CR) or Partial Response (PR) according to the Cheson 2007 response criteria

    Measured: up to 3 months from accrual

  7. Incidence of grade 3 or higher Toxicity measured by CTCAE v.4 at any time during therapy and follow-up.

    Toxicity amount of grade 3 or more as CTCAE

    Measured: 30 months from accrual

  8. Quality of life

    EORTC QLQC30 questionnaire

    Measured: baseline, 6-12-18-24 months from randomisation

Timeline

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

  1. First posted3 Feb 2015 (estimated)
  2. Study startMay 2010
  3. Primary completionDec 2017
  4. Study completionJan 2019 (estimated)

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02354313
Sponsor's protocol ID
IIL-MCL0208
Other IDs
2009-012807-25, 2009
Acronym
MCL0208
Status last verified
Feb 2018
First submitted
23 Jun 2011
Last updated
9 Feb 2018
Results posted
No
Data monitoring committee
No

Publications

  • Ragaini S, Galli A, Genuardi E, Gandossini M, Alessandria B, Civita AM, Evangelista A, Amaducci E, Stefoni V, Cavallo F, Ballerini F, Puccini B, Vallisa D, Michieli M, Pascarella A, Palmas A, Patti C, Lucchini E, Careddu MG, Merli M, Postorino M, Boccomini C, Balzarotti M, Zilioli VR, Gomes da Silva M, Bruno B, Rizzo E, Ladetto M, Malcovati L, Ferrero S. Large clones of clonal hematopoiesis affect outcome in mantle cell lymphoma: results from the FIL MCL0208 clinical trial. Blood Adv. 2025 Apr 22;9(8):1805-1815. doi: 10.1182/bloodadvances.2024014948.

    PubMed 39808795

  • Zaccaria GM, Ferrero S, Hoster E, Passera R, Evangelista A, Genuardi E, Drandi D, Ghislieri M, Barbero D, Del Giudice I, Tani M, Moia R, Volpetti S, Cabras MG, Di Renzo N, Merli F, Vallisa D, Spina M, Pascarella A, Latte G, Patti C, Fabbri A, Guarini A, Vitolo U, Hermine O, Kluin-Nelemans HC, Cortelazzo S, Dreyling M, Ladetto M. A Clinical Prognostic Model Based on Machine Learning from the Fondazione Italiana Linfomi (FIL) MCL0208 Phase III Trial. Cancers (Basel). 2021 Dec 31;14(1):188. doi: 10.3390/cancers14010188.

    PubMed 35008361

  • Ladetto M, Cortelazzo S, Ferrero S, Evangelista A, Mian M, Tavarozzi R, Zanni M, Cavallo F, Di Rocco A, Stefoni V, Pagani C, Re A, Chiappella A, Balzarotti M, Zilioli VR, Gomes da Silva M, Arcaini L, Molinari AL, Ballerini F, Ferreri AJM, Puccini B, Benedetti F, Stefani PM, Narni F, Casaroli I, Stelitano C, Ciccone G, Vitolo U, Martelli M. Lenalidomide maintenance after autologous haematopoietic stem-cell transplantation in mantle cell lymphoma: results of a Fondazione Italiana Linfomi (FIL) multicentre, randomised, phase 3 trial. Lancet Haematol. 2021 Jan;8(1):e34-e44. doi: 10.1016/S2352-3026(20)30358-6. Epub 2020 Dec 22.

    PubMed 33357480

  • Zaccaria GM, Ferrero S, Rosati S, Ghislieri M, Genuardi E, Evangelista A, Sandrone R, Castagneri C, Barbero D, Lo Schirico M, Arcaini L, Molinari AL, Ballerini F, Ferreri A, Omede P, Zamo A, Balestra G, Boccadoro M, Cortelazzo S, Ladetto M. Applying Data Warehousing to a Phase III Clinical Trial From the Fondazione Italiana Linfomi Ensures Superior Data Quality and Improved Assessment of Clinical Outcomes. JCO Clin Cancer Inform. 2019 Oct;3:1-15. doi: 10.1200/CCI.19.00049.

    PubMed 31633999

  • Ferrero S, Rossi D, Rinaldi A, Bruscaggin A, Spina V, Eskelund CW, Evangelista A, Moia R, Kwee I, Dahl C, Di Rocco A, Stefoni V, Diop F, Favini C, Ghione P, Mahmoud AM, Schipani M, Kolstad A, Barbero D, Novero D, Paulli M, Zamo A, Jerkeman M, da Silva MG, Santoro A, Molinari A, Ferreri A, Gronbaek K, Piccin A, Cortelazzo S, Bertoni F, Ladetto M, Gaidano G. KMT2D mutations and TP53 disruptions are poor prognostic biomarkers in mantle cell lymphoma receiving high-dose therapy: a FIL study. Haematologica. 2020 Jun;105(6):1604-1612. doi: 10.3324/haematol.2018.214056. Epub 2019 Sep 19.

    PubMed 31537689

  • Bomben R, Ferrero S, D'Agaro T, Dal Bo M, Re A, Evangelista A, Carella AM, Zamo A, Vitolo U, Omede P, Rusconi C, Arcaini L, Rigacci L, Luminari S, Piccin A, Liu D, Wiestner A, Gaidano G, Cortelazzo S, Ladetto M, Gattei V. A B-cell receptor-related gene signature predicts survival in mantle cell lymphoma: results from the Fondazione Italiana Linfomi MCL-0208 trial. Haematologica. 2018 May;103(5):849-856. doi: 10.3324/haematol.2017.184325. Epub 2018 Feb 22.

    PubMed 29472356

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lenalidomide in people with MANTLE CELL LYMPHOMA, run by Fondazione Italiana Linfomi - ETS at 53 sites in 2 countries.

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 16 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 9 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 sites in Italy, Portugal. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Results are not available in the source record.

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?

Progression Free Survival (PFS) (time frame: 30 months from randomisation). 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 NCT02354313, which also lists 6 linked publications.

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 Feb 2018.

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