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Mantle Cell LymphomaPhase 2FIL-RBAC500NCT01662050

Phase II Study of Age-Adjusted Rituximab, Bendamustine, Cytarabine as Induction Therapy in Older Patients With MCL

A Phase 2 study testing Rituximab, Bendamustine, Cytarabine. in people with Mantle Cell Lymphoma, run by Fondazione Italiana Linfomi - ETS at 56 sites in Italy.

Completed

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

Official record
Search all trials

Trial summary

A phase 2 study of standard R-BAC (rituximab 375 mg/m2, bendamustine 70 mg/m2, ara-c 800 mg/m2) has been recently ultimated at the Vicenza Hematology Department involving several regional centers on both untreated and previously treated patients with Mantle Cell Lymphoma (MCL). Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Mantle Cell Lymphoma
What is being tested?
Rituximab, Bendamustine, Cytarabine.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
57 participants
Where
56 sitesItaly
Study dates
20 Mar 2012to 11 Sep 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 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Previously untreated patients with MCL aged > 65 years if they are FIT according to the geriatric CGA assessment.
  • age 60-65 years not eligible to high-dose chemotherapy plus transplantation, FIT or UNFIT according to the geriatric CGA assessment.
  • ECOG performance status ≤ 2.
  • Positivity for cyclin D1 and SOX11 [the latter being mandatory in cases lacking cyclin D1- or t(11;14)-negative], CD20 and CD5.
  • Adequate renal function (Creatinine clearance > 40 mL/min), with preserved diuresis.
  • Adequate liver function: alanine aminotransferase (ALT)/aspartate aminotransferase (AST) < 2.5 x upper limit of normal (ULN) value, total bilirubin < 2 mg/dL, unless directly attributable to the patient's tumor.
  • Hepatitis B core antibody (HBcAb) positive/HBsAg negative/HBV-DNA negative patients may be enrolled if correct antiviral prophylaxis is administered at least 2 weeks before initiating protocol treatment.
  • Written informed consent.

Who cannot join

  • Human immunodeficiency virus (HIV) positive.
  • Previous treatment for lymphoma
  • Medical conditions or organ injuries that could interfere with administration of therapy.
  • Active bacterial, viral, or fungal infection requiring systemic therapy.
  • Seizure disorders requiring anticonvulsant therapy.
  • Severe chronic obstructive pulmonary disease with hypoxemia.
Show all 15Show fewer
  • History of severe cardiac disease: New York Heart Association (NYHA) functional class III-IV, myocardial infarction within 6 months, ventricular tachyarrhythmias, dilatative cardiomyopathy, or unstable angina.
  • Uncontrolled diabetes mellitus.
  • Active secondary malignancy.
  • Known hypersensitivity or anaphylactic reactions to murine antibodies and proteins, to Bendamustine or mannitol.
  • Major surgery within 4 weeks of study Day 1.
  • HBsAg+
  • HCVAb+ patients with active viral replication (HCV-RNA+ with AST > 2 x normal limit)
  • Any co-existing medical or psychological condition that would preclude participation in the study or compromise the patient's ability to give informed consent, or that may affect the interpretation of the results, or render the patient at high risk from treatment complications.
  • CNS involvement (a diagnostic lumbar puncture will be performed in patients with the blastoid variant of MCL)

Trial locations and contacts

56 sites in 1 country.

56 sites in 1 country

Italy56 sites

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

    Alessandria, 15121

  • CRO Aviano

    Aviano, PN, 33081

  • A.O. Policlinico Consorziale

    Bari, BA, 70124

  • IRCCS Ospedale Oncologico

    Bari, BA, 70124

  • Comprensorio sanitario di Bolzano

    Bolzano, 39100

  • A.O. Spedali Civili

    Brescia, BS, 25100

  • Ospedale Businco

    Cagliari, CA, 09121

  • Ospedale Cardarelli

    Campobasso, 86100

  • U.O.C. Garibaldi Nesima

    Catania, CT, 95125

  • A.O. Pugliese-Ciacci

    Catanzaro, 88100

  • ASL TO4

    Ciriè-Ivrea-Chivasso, TO, 10043

  • Asur - Zona Territoriale 8

    Civitanova Marche, MC, 62012

  • AO Valduce

    Como, CO, 22100

  • AOU Careggi

    Florence, FI, 50134

  • A.O.U. San Martino

    Genova, GE, 16132

  • PO Vito Fazzi

    Lecce, LE, 73100

  • IRST

    Meldola, 47014

  • U.O.C. Ematologia - Policlinico Universitario

    Messina, ME, 98100

  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

    Milan, MI, 20122

  • A.O. S. Carlo Borromeo di Milano Unità Semplice di Trapianto Midollo - A.O.S.Carlo Borromeo

    Milan, MI, 20153

  • A.O. Niguarda

    Milan, MI, 20162

  • Ospedale Civile di Mirano

    Mirano, VE, 30035

  • Centro Oncologico Modenese (COM)

    Modena, MO, 41100

  • Osp. San Gerardo

    Monza, MI, 20052

  • Osp. Umberto I

    Nocera Inferiore, SA, 84014

  • Università del Piemonte Orientale - Novara

    Novara, 28100

  • Ospedale S. Luigi Gonzaga,

    Orbassano, TO, 10043

  • Università di Padova

    Padova, PD, 35128

  • "La Maddalena"

    Palermo, PA, 90146

  • Ospedali Riuniti Villa Sofia - Cervello

    Palermo, PA, 90146

  • Fondazione IRCCS Policlinico San Matteo,

    Pavia, PV, 27100

  • Presidio ospedaliero di Pescara

    Pescara, PE, 65124

  • Ospedale Civile Guglielmo da Saliceto

    Piacenza, PC, 29121

  • Osp. S. Maria delle Croci

    Ravenna, RA, 48121

  • Azienda Ospedaliera "Bianchi Melacrino Morelli"

    Reggio Calabria, RC, 89125

  • Azienda Ospedaliera Arcispedale "S.Maria Nuova"

    Reggio Emilia, RE, 42100

  • Ospedale degli Infermi di Rimini

    Rimini, RN, 47900

  • A.O. San Camillo Forlanini

    Roma, RM, 00152

  • Nuovo Regina Margherita

    Roma, RM, 00153

  • Università "La Sapienza"

    Roma, RM, 00161

  • A.O. S. Giovanni Addolorata

    Roma, RM, 00184

  • Azienda ULSS 18

    Rovigo, RO, 45100

  • Istituto Clinico Humanitas

    Rozzano, MI, 20089

  • A.O.U. San Giovanni di Dio e Ruggi d'Aragona

    Salerno, SA, 84131

  • Az. Ospedaliera Univ. Senese

    Siena, SI, 53100

  • A.O. S. Maria di Terni

    Terni, TR, 05100

  • A.O.U. S. Giovanni Battista -Ematologia 2

    Torino, TO, 10126

  • AOU San Giovanni Battista-Ematologia 1

    Torino, TO, 10126

  • U.O.C. Ematologia Ospedale "San Nicola Pellegrino" ASL BAT

    Trani, BT, 70031

  • Ospedale Cardinale G. Panico

    Tricase, LE, 73039

  • Azienda Ospedaliero - Universitaria di Udine

    Udine, UD, 33100

  • Ospedale di Circolo e Fondazione Macchi - Ematologia

    Varese, VA, 21100

  • Ospedale di Circolo e Fondazione Macchi - Oncologia

    Varese, VA, 21100

  • Osp. S. Andrea Vercelli

    Vercelli, VC, 13100

  • Ospedale Policlinico G.B. Rossi (Borgo Roma) Di Verona

    Verona, VR, 37126

  • Ospedale San Bortolo

    Vicenza, VI, 36100

Other trials in Italy

About this study

Official title: Phase II Study of Age-Adjusted R-BAC (Rituximab, Bendamustine, Cytarabine) as Induction Therapy in Older Patients With Mantle Cell Lymphoma (MCL)

A phase 2 study of standard R-BAC (rituximab 375 mg/m2, bendamustine 70 mg/m2, ara-c 800 mg/m2) has been recently ultimated at the Vicenza Hematology Department involving several regional centers on both untreated and previously treated patients with Mantle Cell Lymphoma (MCL). An interim analysis conducted on 30 patients showed that rituximab + bendamustine + ara-c combination had very good clinical activity, but a quite relevant hematological toxicity, especially in previously treated and older patients (Visco C, ICML 2011 Lugano Conference, Poster 236).

Objectives:

Read more

The primary objective is to determine the activity (complete remission rate according to Cheson 2007 criteria) and safety of age-adjusted Rituximab-Bendamustine-Cytarabine (RBAC500) regimen at the end of treatment in older untreated patients with MCL.

The secondary objectives are to determine:

  • The rate of molecular response (characterized by labs of the FIL)
  • The progression-free survival (PFS)
  • The overall survival (OS)
  • The duration of responses (DOR)
  • The rate of patients that complete the expected treatment schedule (6 courses)
  • The rate of patients that are subject to dose reductions or delays
Read the detailed description

Study End points Primary efficacy end point of the study is the proportion of CR defined according to Cheson criteria (2007) at the end of treatment (6 or 4 cycles). Primary safety end point is the occurrence of any of the stop treatment criteria or of any episode of relevant toxicity, as above defined.

Secondary end points are MRD defined response, OS, PFS and DOR (Cheson 2007). Molecular response is the proportion of patients with molecular rearrangements at baseline that become negative during treatment, measured by qualitative and quantitative PCR.

OS is measured from enrollment until death from any cause. PFS is measured from the time of enrollment until disease progression, relapse or death from any cause. DOR is measured from the first assessment that documents response (CR or PR) to the date of disease relapse or progression. Minimum follow up required for all patients will be 24 months.

Being tested
Rituximab, Bendamustine, Cytarabine.
Keywords
MCL, Mantle Cell Lymphoma, Older
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.

  • Rituximab, Bendamustine, Cytarabine.Drug

    6 cycles of 28 days with Rituximab, Bendamustine and Cytarabine (R-BAC). Rituximab 375mg/mq; Bendamustine 70mg/mq; Cytarabine 500mg/mq.

Study groups in NCT01662050
Study groupRoleWhat they receive
One arm for all patients.ExperimentalRituximab, Bendamustine, Cytarabine
Receives: Drug: Rituximab, Bendamustine, Cytarabine.

What is being measured

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

  1. complete remission rate at the end of treatment

    The primary objective is to determine the activity [complete remission rate (CR) according to Cheson 2007 criteria]

    Measured: 6 months

  2. Toxicity will be represented by the occurrence of any of the stop treatment criteria or of any episode of relevant toxicity

    Relevant toxicity:

    Grade 4 cytopenia lasting for more than 6 days or Grade 3-4 non-hematologic toxicity or Febrile neutropenia lasting for more than 3 consecutive days.

    Stop treatment criteria:

    1. Occurrence of relevant toxicity for two subsequent or consecutive cycles.
    2. Grade 3-4 hematological or non-hematological toxicity on day +28 of a cycle not resolving within two weeks.
    3. Grade 3-4 hematological or non-hematological toxicity on day +28 of a cycle after 25% dose reduction.
    4. Patient refusal to procede with further cycles due to perceived excessive toxicity.
    5. Any unpredictable drug related event that suggests against study continuation

    Measured: 6 months

Secondary outcomes (6)

  1. the rate of molecular response

    the rate of molecular response (characterized by labs of the FIL)

    Measured: 6 months

  2. the progression-free survival (PFS)

    the progression-free survival (PFS)is defined as the time from enrollment to complete remission with disappearance of all evidence of disease, disease progression or relapse or death from any cause.

    Measured: 30 months

  3. the overall survival (OS)

    the overall survival (OS) is defined as the time from enrollment to death from any cause

    Measured: 30 months

  4. the duration of responses (DOR)

    the duration of responses (DOR)

    Measured: 30 months

  5. the rate of completion of treatment

    the rate of patients that complete the expected treatment schedule (6 courses)

    Measured: 6 months

  6. the rate of dose reductions or delays

    the rate of patients that are subject to dose reductions or delays

    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 posted10 Aug 2012 (estimated)
  2. Study start20 Mar 2012
  3. Primary completionAug 2014
  4. Study completion11 Sep 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
57 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01662050
Sponsor's protocol ID
FIL-RBAC500
Acronym
FIL-RBAC500
Status last verified
Aug 2022
First submitted
26 Jun 2012
Last updated
9 Aug 2022
Results posted
No
Data monitoring committee
No

Publications

  • Tisi MC, Moia R, Patti C, Evangelista A, Ferrero S, Spina M, Tani M, Botto B, Celli M, Puccini B, Cencini E, Di Rocco A, Chini C, Ghiggi C, Zambello R, Zanni M, Sciarra R, Bruna R, Ferrante M, Pileri SA, Quaglia FM, Stelitano C, Re A, Volpetti S, Zilioli VR, Arcari A, Merli F, Visco C. Long-term follow-up of rituximab plus bendamustine and cytarabine in older patients with newly diagnosed MCL. Blood Adv. 2023 Aug 8;7(15):3916-3924. doi: 10.1182/bloodadvances.2023009744.

    PubMed 37171620

  • Visco C, Chiappella A, Nassi L, Patti C, Ferrero S, Barbero D, Evangelista A, Spina M, Molinari A, Rigacci L, Tani M, Rocco AD, Pinotti G, Fabbri A, Zambello R, Finotto S, Gotti M, Carella AM, Salvi F, Pileri SA, Ladetto M, Ciccone G, Gaidano G, Ruggeri M, Martelli M, Vitolo U. Rituximab, bendamustine, and low-dose cytarabine as induction therapy in elderly patients with mantle cell lymphoma: a multicentre, phase 2 trial from Fondazione Italiana Linfomi. Lancet Haematol. 2017 Jan;4(1):e15-e23. doi: 10.1016/S2352-3026(16)30185-5. Epub 2016 Dec 5.

    PubMed 27927586

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Rituximab, Bendamustine, Cytarabine. in people with Mantle Cell Lymphoma, run by Fondazione Italiana Linfomi - ETS at 56 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 8 inclusion and 15 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 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 56 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 remission rate at the end of treatment (time frame: 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 NCT01662050, which also lists 2 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 Aug 2022.

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