Clinical trial NCT01164267 (phase 2, status: completed)
Conditions: marginal zone b-cell lymphoma
ICD codes: S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S
Drugs: everolimus
SMILES: [H][C@@]1(C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\C=C(C)\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\C=C\C=C\C=C(C)\[C@H](C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@@]3([H])C(=O)O2)OC)CC[C@@H](OCCO)[C@@H](C1)OC
Eligibility criteria:

        Inclusion Criteria:

          1. Histologically proven diagnosis of marginal zone B-cell lymphoma relapsing/refractory
             following at least 1 prior systemic treatment (chemotherapy and or monoclonal
             antibodies).

          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:

          1. Patients with newly diagnosed MZL.

          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.