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

NCT ID: NCT01170052

Last Updated: 2011-03-16

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2014-04-30

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

Conditions

Mantle Cell Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Temsirolimus

Temsirolimus 75mg i.v. day 1, 8, 15, 21 for a 28 day cycle with a maximum of 6 Cycles.

Intervention Type: DRUG

Bendamustine

Bendamustin 90mg/m2 i.v. day 2 and 3 for a 28 day cycle with a maximum of 6 Cycles.

Intervention Type: DRUG

Temsirolimus

Consolidation Therapy for Patients reached CR or PR with Temsirolimus 75mg weekly until progression.

Intervention Type: DRUG

Other Intervention Names

Torisel®

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role: collaborator

Mundipharma K.K.

INDUSTRY

Sponsor Role: collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Charite University, Berlin, Germany

Principal Investigators

Christian Scholz, PD Dr.

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Locations

Dept. of Hematology and Oncology, Charité, Campus Charité Mitte

Berlin, State of Berlin, Germany

Dept. of Hematology and Oncology, Charité, Campus Benjamin Franklin

Berlin, State of Berlin, Germany

Dept. of Hematology and Oncology, Charité, Campus Virchow Klinikum Charité

Berlin, State of Berlin, Germany

Countries

Germany

Other Identifiers

EudraCT-No.: 2009-014844-13

Identifier Type: -

Identifier Source: org_study_id