Clinical trial NCT01170052: Bendamustine and Temsirolimus in Patients With Relapsed or Refractory Mantle Cell Non-Hodgkin's Lymphoma (NHL)
Official title: Phase I/II Study With Bendamustine and Temsirolimus in Patients With Relapsed or Refractory Mantle Cell Non-hodgkin's Lymphoma (NHL) Not Eligible for High Dose Chemotherapy and Autologous/Allogeneic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Mantle Cell Lymphoma
Keywords: Relapsed Mantle Cell Lymphoma
Refractory Mantle Cell Lymphoma
Non-Hodgkins Lymphoma
Temsirolimus
Bendamustine
Phase 1/2
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Wyeth is now a wholly owned subsidiary of Pfizer
name: Mundipharma K.K.
First posted: 2010-07-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Phase I: Dose-finding
timeFrame: 6 months
measure: Phase II: Response Rate (Overall response rate, complete and partial response)
timeFrame: 6 months
Secondary outcomes:
measure: Progression free survival
timeFrame: 2 years
measure: Safety and Tolerability of Temsirolimus and Bendamustine Combination Therapy
timeFrame: 2 years
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Dept. of Hematology and Oncology, Charité, Campus Charité Mitte
city: Berlin
country: Germany
facility: Dept. of Hematology and Oncology, Charité, Campus Benjamin Franklin
city: Berlin
country: Germany
facility: Dept. of Hematology and Oncology, Charité, Campus Virchow Klinikum Charité
Study officials:
affiliation: Charite University, Berlin, Germany
name: Christian Scholz, PD Dr.
role: PRINCIPAL_INVESTIGATOR
References: