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Marginal Zone B-cell LymphomaPhase 2NCT01164267

Multicenter Phase II Study to Evaluate the Clinical Activity and the Safety Profile of Everolimus in Marginal Zone B-cell Lymphomas (MZL)

A Phase 2 study testing Everolimus in people with Marginal Zone B-cell Lymphoma, run by International Extranodal Lymphoma Study Group (IELSG) at 10 sites in 3 countries.

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 multicenter open-label uncontrolled phase II study. There are no previous clinical data to estimate the expected response rate of everolimus in MALT lymphomas and in the other less common MZLs (i.e. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Marginal Zone B-cell Lymphoma
What is being tested?
Everolimus
Type of treatment
Pill or oral medicine
How many people
30 participants
Where
10 sitesin 3 countries
Study dates
Mar 2010to Dec 2012
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

  • Histologically proven diagnosis of marginal zone B-cell lymphoma relapsing/refractory following at least 1 prior systemic treatment (chemotherapy and or monoclonal antibodies).
  • Any stage (Ann Arbor I-IV).
  • No evidence of histologic transformation to aggressive lymphoma.
  • Measurable or evaluable disease.
  • Age > 18 years.
  • Life expectancy of at least 3 months.
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  • ECOG performance status 0-1.
  • No prior diagnosis of neoplasm within 5 years, except cervical type 1 intraepithelial neoplasia or localized non-melanomatous skin cancer.
  • In case of prior diagnosis of solid organ tumors, no treatment over the last 5 years ond no current evidence of disease.
  • No prior chemo-or radiotherapy in the last 6 weeks, no prior immunotherapy in the last 8 weeks, no corticosteroids during the last 4 weeks unless low-dose prednisone chronically administered for indications other than lymphoma or lymphoma-related symptoms.
  • No major impairment of bone marrow function, renal function or liver function unless due to lymphoma.
  • No evidence of active opportunistic infections, no HIV infection, no evidence of HBV infection, no active HCV infection.
  • Women of childbearing potential are using effective contraception, are not breast feeding, are not pregnant and agree not to become pregnant during participation in the trial and during the 12 months thereafter. A negative pregnancy test is mandatory for all patients < 50 years (unless considered unnecessary by the investigator).
  • Men agree not to father a child during participation in the trial and during the 12 months thereafter.
  • No serious cardiac, neurological or psychiatric disorders potentially hampering compliance with the study protocol and follow-up schedule.
  • Fasting serum cholesterol ≤ 200 mg/dL or ≤ 5 mmol/L AND fasting triglycerides ≤ 200 mg/dL. NOTE: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication.
  • Written informed consent.

Who cannot join

  • Patients with newly diagnosed MZL.
  • Patients with concomitant or past hematological malignancies.
  • Presence or history of CNS lymphoma localization (either parenchymal or meningeal disease).
  • Cardiovascular disease (congestive heart failure; NYHA III or IV), unstable angina pectoris, significant cardiac arrhythmias requiring chronic treatment, or prior history of myocardial infarction in the last 3 months.
  • Serious underlying medical condition which could impair the ability of the patient to participate in the trial (e.g. uncontrolled diabetes mellitus, gastric ulcers, active autoimmune disease, ongoing infection e.g. HIV, hepatitis).
  • Concurrent anticancer drugs / treatments and experimental drugs. Previous radiation is allowed, unless the indicator lesion(s) are in the irradiated field.
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  • Previous organ transplantation
  • Participation in another clinical trial within 30 days prior to trial entry
  • Pregnant or lactating women.

Trial locations and contacts

10 sites in 3 countries.

10 sites in 3 countries

Italy8 sites

  • Policlinico S. Orsola Malpighi

    Bologna

  • Humanitas

    Milan

  • San Raffaele Hospital

    Milan

  • IEO

    Milan

  • INT

    Milan

  • AOU Maggiore della Carità

    Novara

  • IRCCS Policlinico S. Matteo

    Pavia

  • AOU S. Giovanni Battista

    Torino

Other trials in Italy

Austria1 site

  • General Hospital AKH

    Vienna

Other trials in Austria

Switzerland1 site

  • IOSI

    Bellinzona

Other trials in Switzerland

About this study

Official title: A Multicenter Phase II Study to Evaluate the Clinical Activity and the Safety Profile of Everolimus (RAD001) in Marginal Zone B-cell Lymphomas (MZL) EudraCT Number 2009-011725-14

This is a multicenter open-label uncontrolled phase II study. There are no previous clinical data to estimate the expected response rate of everolimus in MALT lymphomas and in the other less common MZLs (i.e. nodal and splenic) refractory or relapsing after at least 1 prior systemic treatment (chemotherapy or immunotherapy).

The primary objective of this study is to define the antitumor activity, in term of overall response rate (ORR), as sum of complete remissions (CR) and partial remissions (PR) of everolimus in relapsed or refractory marginal zone B-cell lymphomas.

The secondary objectives of this study are to assess safety, as acute or long-term toxicity, response duration (RD) (time to relapse or progression) in responders and progression-free survival (PFS) (time to disease progression or death from any cause) in all patients.

Being tested
Everolimus
Medical subject headings
Lymphoma, B-Cell, Marginal Zone

What participants receive

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

  • EverolimusDrug

    Everolimus (tablets, 5 mg) is given orally at the dose of 10 mg/day from day 1 to day 28 of each cycle for up to a total of 6 cycles or until progression. Patients with CR or PR may continue treatment until PD if well tolerated

What is being measured

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

  1. Total Body CT-Scan

    Measured: Every 12 weeks

Timeline

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

  1. First posted16 Jul 2010 (estimated)
  2. Study startMar 2010
  3. Primary completionDec 2012

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
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01164267
Sponsor's protocol ID
IELSG 34
Other IDs
2009-011725-14, 2009
Status last verified
May 2012
First submitted
15 Jul 2010
Last updated
25 Nov 2013
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Everolimus in people with Marginal Zone B-cell Lymphoma, run by International Extranodal Lymphoma Study Group (IELSG) at 10 sites in 3 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 17 inclusion and 9 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 25 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Italy, Austria, Switzerland. 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?

Total Body CT-Scan (time frame: Every 12 weeks). 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 NCT01164267.

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 25 Nov 2013.

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