Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Charite University, Berlin, Germany
With
Wyeth is now a wholly owned subsidiary of Pfizer
Mundipharma K.K.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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, severe diabetes)
Abnormal liver function: transaminases or total bilirubin \> 2 x upper limit of normal (ULN)
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 cervix.
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 informed.
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.
