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

Primary Purpose

Mantle Cell Lymphoma

Status
Withdrawn
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Temsirolimus
Bendamustine
Temsirolimus
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mantle Cell Lymphoma focused on measuring Relapsed Mantle Cell Lymphoma, Refractory Mantle Cell Lymphoma, Non-Hodgkins Lymphoma, Temsirolimus, Bendamustine, Phase 1/2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Dept. of Hematology and Oncology, Charité, Campus Charité Mitte
  • Dept. of Hematology and Oncology, Charité, Campus Benjamin Franklin
  • Dept. of Hematology and Oncology, Charité, Campus Virchow Klinikum Charité

Outcomes

Primary Outcome Measures

Phase I: Dose-finding
Is the combination of temsirolimus alongside with bendamustine at the suggested dose feasible or are dose reductions necessary. Number of dose reductions or delays of therapy due to hematologic toxicities (CTCAE) or other adverse events according to protocoll.
Phase II: Response Rate (Overall response rate, complete and partial response)
What is the response rate of a therapy with temsirolimus and bendamustine.

Secondary Outcome Measures

Progression free survival
This is defined as the period of time between the admission into the clinical trial and the progression of the lymphoma or death of any kind.
Safety and Tolerability of Temsirolimus and Bendamustine Combination Therapy
Detection of overall toxicity, serious adverse events (SAE), suspected unexpected serious adverse reactions (SUSAR) during treatment with temsirolimus and bendamustine.

Full Information

First Posted
July 14, 2010
Last Updated
March 15, 2011
Sponsor
Charite University, Berlin, Germany
Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer, Mundipharma K.K.
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1. Study Identification

Unique Protocol Identification Number
NCT01170052
Brief Title
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

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Withdrawn
Why Stopped
insufficient enrollment
Study Start Date
May 2010 (undefined)
Primary Completion Date
April 2012 (Anticipated)
Study Completion Date
April 2014 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Charite University, Berlin, Germany
Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer, Mundipharma K.K.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mantle Cell Lymphoma
Keywords
Relapsed Mantle Cell Lymphoma, Refractory Mantle Cell Lymphoma, Non-Hodgkins Lymphoma, Temsirolimus, Bendamustine, Phase 1/2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Temsirolimus
Other Intervention Name(s)
Torisel®
Intervention Description
Temsirolimus 75mg i.v. day 1, 8, 15, 21 for a 28 day cycle with a maximum of 6 Cycles.
Intervention Type
Drug
Intervention Name(s)
Bendamustine
Intervention Description
Bendamustin 90mg/m2 i.v. day 2 and 3 for a 28 day cycle with a maximum of 6 Cycles.
Intervention Type
Drug
Intervention Name(s)
Temsirolimus
Intervention Description
Consolidation Therapy for Patients reached CR or PR with Temsirolimus 75mg weekly until progression.
Primary Outcome Measure Information:
Title
Phase I: Dose-finding
Description
Is the combination of temsirolimus alongside with bendamustine at the suggested dose feasible or are dose reductions necessary. Number of dose reductions or delays of therapy due to hematologic toxicities (CTCAE) or other adverse events according to protocoll.
Time Frame
6 months
Title
Phase II: Response Rate (Overall response rate, complete and partial response)
Description
What is the response rate of a therapy with temsirolimus and bendamustine.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Progression free survival
Description
This is defined as the period of time between the admission into the clinical trial and the progression of the lymphoma or death of any kind.
Time Frame
2 years
Title
Safety and Tolerability of Temsirolimus and Bendamustine Combination Therapy
Description
Detection of overall toxicity, serious adverse events (SAE), suspected unexpected serious adverse reactions (SUSAR) during treatment with temsirolimus and bendamustine.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Scholz, PD Dr.
Organizational Affiliation
Charite University, Berlin, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. of Hematology and Oncology, Charité, Campus Charité Mitte
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Dept. of Hematology and Oncology, Charité, Campus Benjamin Franklin
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Facility Name
Dept. of Hematology and Oncology, Charité, Campus Virchow Klinikum Charité
City
Berlin
ZIP/Postal Code
13353
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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