Clinical trial NCT01170052 (phase 1/phase 2, status: withdrawn)
Conditions: mantle cell lymphoma
ICD codes: S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S
Drugs: temsirolimus, bendamustine, temsirolimus
SMILES: CN1N=NC2=C(N=CN2C1=O)C(N)=O, ClCCN(CCCl)P1(=O)NCCCO1, CN1N=NC2=C(N=CN2C1=O)C(N)=O
Reason stopped: 
    insufficient enrollment
  
Eligibility criteria:

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

          -  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.

          -  Inability to comply with study requirements