| Exclusion Criteria: | 1) Patients with evidence of disease according to the revised IWRC after completion of the first-line R-chemotherapy treatment, prior to study entry.
2) Patients receiving ongoing radiation therapy or who received radiation therapy to the residual tumor masses < 4 weeks from start of study drug.
3) Patients who have previously received systemic mTOR inhibitor (sirolimus, temsirolimus, everolimus, etc).
4) Patients with evidence of current central nervous system (CNS) involvement with lymphoma. Patients who have only had prophylactic intrathecal chemotherapy against CNS disease are eligible.
5) Patients with transformed follicular lymphoma.
6) Patients who received ibritumomab tiuxetan (ZevalinŽ), in order to avoid potential delayed kidney toxicities.
7) Patients who had myelosuppressive chemotherapy or biologic therapy < 3 weeks from start of study drug.
8) Patients receiving chronic systemic immunosuppressive agents. Inhaled and topical steroids are acceptable. Patients may be receiving stable (not increased within the last month) chronic doses of corticosteroids with a maximum dose of 20 mg of prednisone or </=5 mg of dexamethasone per day, if they are being given for disorders other than lymphoma such as rheumatoid arthritis, polymyalgia rheumatica, adrenal insufficiency or asthma.
9) Patients with active, bleeding diathesis.
10) Patients with a known history of HIV seropositivity.
11) Patients with known hypersensitivity to RAD001 (everolimus) or other rapamycins (sirolimus, temsirolimus) or to any of the excipients.
12) Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:unstable angina pectoris, symptomatic congestive heart failure (NYHA II, III, IV), myocardial infarction </= 6 months prior to first study drug, serious uncontrolled cardiac arrhythmia, cerebrovascular accidents </= 6 months before study drug start; severely impaired lung function as defined as spirometry and DLCO that is </= 50% of the normal predicted value and/or O2 saturation that is 88% or less at rest on room air;
13) Continuation #12) Poorly controlled diabetes as defined by fasting serum glucose >2.0 x ULN; any active (acute or chronic) or uncontrolled infection/disorders that impair the ability to evaluate the patient or for the patient to complete the study; nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by this study drug, such as severe hypertension that is not controlled with medical management and thyroid abnormalities whose thyroid function cannot be maintained in the normal range by medication;
14) Continuation #13) Liver disease such as cirrhosis or decompensated liver disease.
15) Patients who have a history of another primary malignancy </= 3 years, with the exception of non-melanoma skin cancer and carcinoma in situ of uterine cervix.
16) Female patients who are pregnant or breast feeding, or of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 8 weeks after study drug administration. Highly effective contraception methods include: Total abstinence (when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception; Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment.
17) Continuation #16) In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment; Male sterilization (at least 6 months prior to screening). For female subjects on the study the vasectomized male partner should be the sole partner for that subject; Combination of any two of the following (a+b or a+c, or b+c): a. Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception; b. Placement of an intrauterine device (IUD) or intrauterine system (IUS); c. Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository. In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking study treatment.
18) Patients who are using other investigational agents or who had received investigational drugs </= 4 weeks prior to study drug start.
19) Patients unwilling to or unable to comply with the protocol. |