Multicenter Phase II Study to Evaluate the Clinical Activity and the Safety Profile of Everolimus in Marginal Zone B-cell Lymphomas (MZL)
NCT ID: NCT01164267
Last Updated: 2013-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
30 participants
INTERVENTIONAL
2010-03-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Everolimus
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
Eligibility Criteria
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Inclusion Criteria
2. Any stage (Ann Arbor I-IV).
3. No evidence of histologic transformation to aggressive lymphoma.
4. Measurable or evaluable disease.
5. Age \> 18 years.
6. Life expectancy of at least 3 months.
7. ECOG performance status 0-1.
8. No prior diagnosis of neoplasm within 5 years, except cervical type 1 intraepithelial neoplasia or localized non-melanomatous skin cancer.
9. In case of prior diagnosis of solid organ tumors, no treatment over the last 5 years ond no current evidence of disease.
10. 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.
11. No major impairment of bone marrow function, renal function or liver function unless due to lymphoma.
12. No evidence of active opportunistic infections, no HIV infection, no evidence of HBV infection, no active HCV infection.
13. 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.
14. No serious cardiac, neurological or psychiatric disorders potentially hampering compliance with the study protocol and follow-up schedule.
15. 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.
16. Written informed consent.
Exclusion Criteria
2. Patients with concomitant or past hematological malignancies.
3. Presence or history of CNS lymphoma localization (either parenchymal or meningeal disease).
4. 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.
5. 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).
6. Concurrent anticancer drugs / treatments and experimental drugs. Previous radiation is allowed, unless the indicator lesion(s) are in the irradiated field.
7. Previous organ transplantation
8. Participation in another clinical trial within 30 days prior to trial entry
9. Pregnant or lactating women.
18 Years
ALL
No
Sponsors
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International Extranodal Lymphoma Study Group (IELSG)
OTHER
Responsible Party
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Principal Investigators
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Emanuele Zucca, MD
Role: STUDY_CHAIR
IOSI
Annarita Conconi, MD
Role: STUDY_CHAIR
AOU Maggiore della Carità Novara
Locations
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General Hospital AKH
Vienna, , Austria
Policlinico S. Orsola Malpighi
Bologna, , Italy
Humanitas
Milan, , Italy
San Raffaele Hospital
Milan, , Italy
IEO
Milan, , Italy
INT
Milan, , Italy
AOU Maggiore della Carità
Novara, , Italy
IRCCS Policlinico S. Matteo
Pavia, , Italy
AOU S. Giovanni Battista
Torino, , Italy
IOSI
Bellinzona, , Switzerland
Countries
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Related Links
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Related Info
Other Identifiers
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2009-011725-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
IELSG 34
Identifier Type: -
Identifier Source: org_study_id