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

Charité University Medicine Berlin

Status and phase

Withdrawn

Phase 2

Phase 1

Conditions

Mantle Cell Lymphoma

Treatments

Drug: Bendamustine

Drug: Temsirolimus

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01170052

EudraCT-No.: 2009-014844-13

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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