Status:
WITHDRAWN
Bendamustine and Temsirolimus in Patients With Relapsed or Refractory Mantle Cell Non-Hodgkin's Lymphoma (NHL)
Lead Sponsor:
Charite University, Berlin, Germany
Collaborating Sponsors:
Wyeth is now a wholly owned subsidiary of Pfizer
Mundipharma K.K.
Conditions:
Mantle Cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to assess the safety, tolerability and activity of the combination of bendamustine and rituximab in patients with relapsed/refractory mantle cell lymphoma who are not elig...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2014
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01170052
Start Date
May 1 2010
End Date
April 1 2014
Last Update
March 16 2011
Active Locations (3)
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1
Dept. of Hematology and Oncology, Charité, Campus Charité Mitte
Berlin, State of Berlin, Germany, 10117
2
Dept. of Hematology and Oncology, Charité, Campus Benjamin Franklin
Berlin, State of Berlin, Germany, 12203
3
Dept. of Hematology and Oncology, Charité, Campus Virchow Klinikum Charité
Berlin, State of Berlin, Germany, 13353