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Indolent Non-follicularPhase 2IIL INFL09NCT01929265

A Phase II Study for Patients With Indolent Non-follicular Non-Hodgkin's Lymphoma

A Phase 2 study testing Bendamustine in people with Indolent Non-follicular and Non-Hodgkin's Lymphoma, run by Fondazione Italiana Linfomi - ETS at 25 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 chemoimmunotherapy with the combination of Bendamustine + Rituximab in patients with advanced untreated Indolent non Follicular non-Hodgkin Lymphomas (INFL). Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Bendamustine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
73 participants
Where
25 sitesItaly
Study dates
Jan 2011to May 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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Understand and voluntarily sign an informed consent form
  • Histological (bone marrow or lymph nodes biopsy) proven diagnosis of B-cell CD20- positive non-follicular NHL according to REAL/WHO Classification:
  • small lymphocytic lymphoma-SLL (bone marrow or lymph nodes biopsy ii. lymphoplasmacytic/citoid lymphoma/ Waldenstrom macroglobulinemia(bone marrow or lymph nodes biopsy) iii. nodal marginal zone lymphoma (lymph nodes biopsy)
  • Untreated patients
  • Stage III or IV or stage II with more than three involved sites
  • Presence of at least one of the following criteria for the definition of active disease:
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  • Systemic symptoms
  • Hemoglobin less than 10 g/dL (due to lymphoma)
  • Platelets less than 100 x 10 9/L (due to lymphoma)
  • Diffuse bone marrow infiltrate
  • Lymphocyte doubling time less than 12 months (in leukemic cases)
  • Bulky disease (>7 cm)
  • Aged 18 - 75 Life expectancy >6 months
  • ECOG performance status 0-2
  • LVEF ≥45% or FS ≥37%
  • ANC ≥1 x 10 9/l and Platelets count ≥75 x 10 9/l, unless due to bone marrow involvement by follicular lymphoma
  • Creatinine up to 1.5 x ULN
  • Conjugated bilirubin up to 2 x ULN
  • Alkaline phosphatase and transaminases up to 2 x ULN
  • Written informed content

Who cannot join

  • Patients with diagnosis of marginal zone lymphoma of splenic or MALT origin
  • Patients with diagnosis of typical Chronic Lymphocytic Leukemia (CLL)
  • 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
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  • Concurrent medical condition which might exclude administration of therapy
  • Cardiac insufficiency (NYHA grade III/IV)
  • 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
  • HIV positivity
  • HBV positivity with the exception of patients HbsAg negative and Ab anti-Hbcore positive(these patientes need to receive prophylaxis with Lamivudine)
  • HCV positivity with the exception of patients with HCV RNA negative.
  • CNS involvement by lymphoma
  • Participation at the same time in another study in with investiogational 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
  • Women in pregnancy or breastfeeding

Trial locations and contacts

25 sites in 1 country.

25 sites in 1 country

Italy25 sites

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

    Alessandria, AL, 15121

  • Div. Oncologia Medica - CRO, Centro di Riferimento Oncologico

    Aviano, PN

  • Divisione di Ematologia e Trapianti, Ospedale San Maurizio

    Bolzano, BZ

  • SC Ematologia Spedali Civili

    Brescia, BS

  • Divisione Ematologia I , Ospedale San Martino

    Genova, GE

  • S.C. Ematologia Azienda Ospedaliera Papardo

    Messina, ME

  • Divisione di Ematologia Ospedale Niguarda

    Milan, MI

  • UOC Ematologia 1/CTMO, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

    Milan

  • Centro Oncologico Modenese

    Modena, MO

  • Oncoematologia Istituto Pascale

    Naples

  • S.C.D.U Ematologia Azienda Ospedaliero Universitaria Maggiore

    Novara

  • Ematologia Azienda Ospedaliero Universitaria Paolo Giaccone

    Palermo, PA

  • UO Ematologia Università - Policlinico San Matteo

    Pavia

  • Ematologia Ospedale Santo Spirito

    Pescara

  • UOA Ematologia, Ospedale Civile Ospedale G. da Saliceto

    Piacenza

  • Div. Ematologia AO Bianchi Melacrino Morelli

    Reggio Calabria

  • Ematologia, Azienda Ospedaliera Arcispedale "S.Maria Nuova"

    Reggio Emilia

  • Ematologia, Università "La Sapienza"

    Roma

  • Divisione di Oncologia Medica ed Ematologia, Istituto Clinico Humanitas

    Rozzano, Milano

  • Divisione di Ematologia, Centro Trapianto di Cellule Staminali

    San Giovanni Rotondo, Foggia

  • Clinica Ematologia Policlino Le Scotte

    Siena

  • Struttura Complessa di Onco-Ematologia Azienda Ospedaliera S.Maria

    Terni

  • SC Ematologia - Città della Salute e della Scienza

    Torino

  • SC Ematologia U - Città della Salute e della Scienza

    Torino

  • Clinica Ematologica e Unità di Terapie Cellulari 'Carlo Melzi' AOU S. Maria della Misericordia

    Udine

Other trials in Italy

About this study

Official title: A Phase II Study of Bendamustine in Combination With Rituximab as Initial Treatment for Patients With Indolent Non-follicular Non-Hodgkin's Lymphoma

This is a prospective, multicenter phase II trial designed to determine efficacy and safety of a chemoimmunotherapy with the combination of Bendamustine + Rituximab in patients with advanced untreated Indolent non Follicular non-Hodgkin Lymphomas (INFL).

Read the detailed description

This is a prospective, multicenter phase II trial designed to determine efficacy and safety of a chemoimmunotherapy with the combination of Bendamustine + Rituximab in patients with advanced untreated Indolent non Follicular non-Hodgkin Lymphomas (INFL).

The study includes and induction phase and a consolidation phase.

Being tested
Bendamustine
Keywords
INFL, Indolent non-follicular, untreated INFL
Medical subject headings
Lymphoma, Non-Hodgkin

What participants receive

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

  • BendamustineDrug

    Also called RIBOMUSTIN

    INDUCTION PHASE

    Rituximab - Bendamustine (RB): cycles 1 to 4 (0, 4, 8, 12 week):

    Rituximab: 375 mg/sqm iv, day 1*

    Bendamustine: 90 mg/sqm iv, days 1-2 or days 2-3 according to istitutional/patient/physician choice

    Repeat cycles every 28 days for a total of 4 cycles

    *In cycle 1, in order to avoid tumor lysis syndrome, Rituximab will be given on day 8.

    CONSOLIDATION PHASE

    Rituximab - Bendamustine (RB): cycles 5 to 6 (16, 20 week):

    Rituximab: 375 mg/sqm iv day 1

    Bendamustine: 90 mg/sqm iv days 1-2 or days 2-3 according to istitutional/patient/physician choice

    Rituximab two monthly doses

    Rituximab: 375 mg/sqm iv week 24 and 28

Study groups in NCT01929265
Study groupRoleWhat they receive
Rituximab - Bendamustine (RB)Experimental1 arm: Rituximab - Bendamustine (RB) 1 arm for all patients
Receives: Drug: Bendamustine

What is being measured

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

  1. Complete remission rate (CR)

    Evaluated at the end of treatment

    Measured: 5 months

Secondary outcomes (5)

  1. Safety analysis

    Evaluated during and at the end of treatment. Percentage of patients with adverse, hematological and non-hematological toxic events

    Measured: 5 months

  2. Overall response rate (ORR)

    Evaluated at the end of treatment. Complete plus partial remission.

    Measured: 5 months

  3. Overall survival (OS)

    Dead for any causes after diagnosis. Evaluated by means of Kaplan-Meier method.

    Measured: at 2 years

  4. Progression free survival (PFS)

    Progression, relapse or dead for any causes after diagnosis. Evaluated by means of Kaplan-Meier method.

    Measured: at 2 years

  5. Disease free survival (PFS)

    Relapse or dead for any causes from the end of treatment, for patients in CR after B+R. Evaluated by means of Kaplan-Meier method.

    Measured: at 2 years

Timeline

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

  1. First posted27 Aug 2013 (estimated)
  2. Study startJan 2011
  3. Primary completionMar 2012
  4. Study completionMay 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
73 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01929265
Sponsor's protocol ID
IIL INFL09
Acronym
IIL INFL09
Status last verified
Mar 2017
First submitted
22 Aug 2013
Last updated
13 Oct 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bendamustine in people with Indolent Non-follicular and Non-Hodgkin's Lymphoma, run by Fondazione Italiana Linfomi - ETS at 25 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 20 inclusion and 21 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 13 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 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 (CR) (time frame: 5 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 NCT01929265.

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 13 Oct 2017.

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