ABOUT THIS STUDY
- Age 18 years or older
- Mantle Cell Lymphoma according to REAL/WHO classification
- First or second relapse or alternatively progression during therapy. Previous use of Bendamustine is permitted, if the patient has reached at least partial remission and progression occured more than 6 months after therapy. Previous high dose chemotherapy with auto-SCT is permitted, if the patient has reached at least partial remission and progression occured more than 12 months after therapy.
- Patients must not be eligible for high dose chemotherapy with auto-SCT or allo-SCT.
- Adequate bone marrow function (hemoglobin > 9g/dl, platelet count >100/nL, absolute neutrophil count >1,5 /nL)
- WHO/ECOG Performance Status 0-2
- Measurable disease (two perpendicular diameters by either physical or radiological examination)
- Life expectancy ≥ 3 weeks
- Written informed consent
- Prior treatment with any m-TOR Inhibitor
- Unstable or severe uncontrolled medical condition (e.g. severe congestive heart
failure, myocardial infarction within the past 6 months, severe, uncontrolled arterial
hypertension, renal insufficiency requiring hemodialysis, severe pulmonary disease,
- Abnormal liver function: transaminases or total bilirubin > 2 x upper limit of normal
- Abnormal renal function: serum creatinine > 2 x upper limit of normal
- Previous malignancy other than non-melanoma skin cancer or carcinoma in situ of the
- Concurrent treatment with strong inhibitors of CYP3A4 and/or inducers of CYP3A4
- Pregnant or breastfeeding women (negative pregnancy test not older than 7 days is
required for women of fertile age). Men and women of child-bearing potential must
agree to use adequate contraception (i.e. failure rate < 1% p.a. )
- Major surgery within 4 weeks before study entry; minor procedures (e.g. Implantation
i.v. port catheter, Lymphnode biopsy) within 1 week before study entry
- Previous therapy with any investigational agents within 28 days before study entry
- Concomitant immunotherapy (e.g. Rituximab) or Chemotherapy other than Bendamustine.
Use of systemic steroids should be documented and the Principal Investigator be
- Central nervous system (CNS) lymphomatous involvement
- HIV positivity
- Current or chronic hepatitis B or hepatitis C infection
- Severe psychiatric illness or Individuals that are placed in an institution due to a
magisterial or judiciary command.
- Inability to comply with study requirements
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