Bendamustine and Temsirolimus in Patients With Relapsed or Refractory Mantle Cell Non-Hodgkin's Lymphoma (NHL)

• Status: Withdrawn
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

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 eligible for high dose chemotherapy and autologous/allogeneic stem cell transplantation.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Charite University, Berlin, Germany
• Collaborators: Mundipharma K.K.; Wyeth is now a wholly owned subsidiary of Pfizer
• Treatments: Bendamustine Hydrochloride; Everolimus; Sirolimus

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