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Waldenstrom's MacroglobulinemiaPhase 2FIL_BRBNCT02371148

Fase II Study With BRB for Non-Hodgkin Lymphoplasmacytic Lymphoma/Waldenstrom Macroglobulinemia's

A Phase 2 study testing Bortezomib-Rituximab-Bendamustine in people with Waldenstrom's Macroglobulinemia, run by Fondazione Italiana Linfomi - ETS at 23 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 Bortezomib plus Rituximab plus Bendamustine in patients with relapsed/refractory Waldenstrom's Macroglobulinemia. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Waldenstrom's Macroglobulinemia
What is being tested?
Bortezomib-Rituximab-Bendamustine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
23 sitesItaly
Study dates
Jun 2014to 22 Jul 2020
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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Histological proven diagnosis of Lymphoplasmacytic/cytoid lymphoma/Waldenstrom macroglobulinemia according to REAL/WHO Classification
  • Relapsed/refractory disease after receiving one line chemotherapy (rituximab). If patients received bortezomib or bendamustine and have obtained a partial response lasting at least two years.
  • Age >= 18
  • Presence of at least one of the following criteria for the definition of active disease: Systemic symptoms or Hemoglobin less than 10 g/dL (due to lymphoma) or Platelets less than 100 x 109/L (due to lymphoma) or symptomatic splenomegaly or Bulky disease (>7 cm) or Hyperviscosity syndrome, peripheral neuropathy up to grade 1 (Waldenstrom's disease-related), hemolytic anemia, and immune complex vasculitis
  • Life expectancy >6 months
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
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  • left ventricular ejection fraction (LVEF) ≥45% or FS ≥37%
  • Creatinine up to 1.5 x upper limit of normal
  • Conjugated bilirubin up to 2 x upper limit of normal
  • Alkaline phosphatase and transaminases up to 2 x upper limit of normal
  • Written informed content

Who cannot join

  • Patients who received bortezomib or bendamustine first-line therapy, that or haven't obtained at least partial response nor partial response lasting at least two years.
  • Patients 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 ductal carcinoma in situ (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
  • Peripheral neuropathy of any grade ≥ 2 [see Appendix Section A]
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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 and HBV-DNA negative and Ab anti-HB core positive (these patients need to receive prophylaxis with Lamivudine)
  • HCV positivity with the exception of patients with HCV RNA negative
  • Participation at the same time in another study in with 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.
  • Women in pregnancy or breastfeeding

Trial locations and contacts

23 sites in 1 country.

23 sites in 1 country

Italy23 sites

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

    Alessandria, 15121

  • A.O. Universitaria Ospedali Riuniti - Ospedale Umberto I Di Ancona

    Ancona, 60126

  • Centro di riferimento Oncologico - Oncologia Medica A

    Aviano (PN)

  • A.O. Ospedale Degli Infermi

    Biella, 13900

  • Ospedale Businco, Divisione di Ematologia

    Cagliari

  • Ospedale S. Giacomo di Castelfranco Veneto

    Castelfranco Veneto, Treviso, 31033

  • Area Vasta Romagna e IRST

    Meldola (FC)

  • AO Riuniti Papardo Piemonte

    Messina, ME, 98158

  • Irccs Ospedale Maggiore Policlinico Di Milano

    Milan, 20122

  • A.O. Universitaria Policlinico Di Modena

    Modena, 41124

  • Ospedale Maggiore Della Carita' - Scdu Ematologia

    Novara, 28100

  • Ospedale San Martino, Asl Oristano- Ematologia

    Oristano, 09170

  • Uo Oncoematologia, Po "A.Tortora"

    Pagani, Salerno, 84016

  • Ematologia Policlinico San Matteo

    Pavia, 27100

  • Ausl Di Piacenza

    Piacenza, 29121

  • AUSL di Ravenna

    Ravenna, RA, 48100

  • A.O. Bianchi - Melacrino - Morelli

    Reggio Calabria, RC, 89125

  • Ausl Di Rimini

    Rimini, 47924

  • Centro di Riferimento Oncologico della Basilicata

    Rionero in Vulture, PZ, 85028

  • Nuovo Regina Margherita

    Roma, RM, 00153

  • Ematologia 1 - A.O. Citta' Della Salute E Della Scienza Di Torino

    Torino, 10126

  • Città della Salute e della Scienza SC Ematologia

    Torino

  • Ematologia - OSPEDALE DI CIRCOLO E FONDAZIONE MACCHI

    Varese, 21100

Other trials in Italy

About this study

Official title: Fase II Study With Bortezomib, Rituximab and Bendamustin-BRB- for Non-Hodgkin Lymphoplasmocytic Lymphoma/Waldenstrom Macroglobulinemia's Patients at First Relapse

This is a prospective, multicenter phase II trial designed to determine efficacy and safety of Bortezomib plus Rituximab plus Bendamustine in patients with relapsed/refractory Waldenstrom's Macroglobulinemia.

Read the detailed description

The progression free survival (PFS) expected for lymphoplasmacytic/lymphoplasmocytoid lymphoma/Waldenstrom macroglobulinemia with the same characteristics indicated into the study and treated with standard Rituximab plus chemotherapy may be estimated to be 50% at 18 months.

The Investigators would consider a positive result to increase 18 months-PFS rate from 50 to 65%.

Being tested
Bortezomib-Rituximab-Bendamustine
Medical subject headings
Waldenstrom Macroglobulinemia

What participants receive

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

  • Bortezomib-Rituximab-BendamustineDrug

    Also called BRB

    Bortezomib-Rituximab-Bendamustine Bortezomib: 1.3 mg/mq sc days 1, 8, 15, 22* Rituximab: 375 mg/sqm i.v. day 1** Bendamustine: 90 mg/sqm iv days 1-2 or days 2-3 according to institutional/physician choice Repeat cycles every 28 days for a total of 6 cycles *In case of toxicity is omitted

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

Study groups in NCT02371148
Study groupRoleWhat they receive
Bortezomib-Rituximab-BendamustineExperimentalBortezomib-Rituximab-Bendamustine (BRB) combination in patients with relapsed/refractory lymphoplasmocytic/lymphoplasmocytoid lymphoma/Waldenstrom macroglobulinemia after one line of therapy.
Receives: Drug: Bortezomib-Rituximab-Bendamustine

What is being measured

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

  1. Progression Free Survival (PFS)

    This is a prospective, multicenter phase II trial designed to determine efficacy and safety of Bortezomib plus Rituximab plus Bendamustine in patients with relapsed/refractory Waldenstrom's Macroglobulinemia. Primary Objective is to assess whether the experimental treatment achieves an absolute increase of PFS rate from 50 to 65% at 18 months with respect to the standard treatment. PFS is measured from the beginning of therapy to the date of disease progression, relapse or death from any cause.

    Patients without any relapse at the end of the follow-up will be censored at their last assessment date.

    Measured: 18 months

Secondary outcomes (4)

  1. Overall Response Rate (ORR)

    Overall response rate (ORR): a patient is defined as a responder if he has a complete or very good partial or partial response, evaluated in based on Waldenstrom macroglobulinemia consensus recommendations of the 6th International Workshop on Waldestrom's macroglobulinemia.

    Measured: 2 years

  2. Overall Survival (OS)

    Overall survival (OS): measured from the beginning of therapy to the date of death from any cause. Patients alive at the time of the final analysis will be censored at the date of the last contact. Minimum follow up time required for all patients will be 2 years.

    Measured: 2 years

  3. Toxicity

    Toxicity: severe, life- threatening, fatal (grade 3, 4 and 5)

    Measured: 2 years

  4. Number of serious adverse events

    Number of serious adverse events are defined according to "Common Terminology Criteria for Adverse Events" (CTCAE), version 4.0

    Measured: 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 posted25 Feb 2015 (estimated)
  2. Study startJun 2014
  3. Primary completionNov 2017
  4. Study completion22 Jul 2020

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
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02371148
Sponsor's protocol ID
FIL_BRB
Acronym
FIL_BRB
Status last verified
Nov 2020
First submitted
13 Feb 2015
Last updated
2 Dec 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bortezomib-Rituximab-Bendamustine in people with Waldenstrom's Macroglobulinemia, run by Fondazione Italiana Linfomi - ETS at 23 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 11 inclusion and 19 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 2 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 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?

Progression Free Survival (PFS) (time frame: 18 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 NCT02371148.

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 2 Dec 2020.

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