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

NCT01170052

Last updated date
Study Location
Dept. of Hematology and Oncology, Charité, Campus Charité Mitte
Berlin, , 10117, Germany
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Mantle Cell Lymphoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Mantle Cell LymphomaBendamustine and Temsirolimus in Patients With Relapsed or Refractory Mantle Cell Non-Hodgkin's Lymphoma (NHL)
NCT01170052
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Advanced Information
Descriptive Information
Brief Title  ICMJE Bendamustine and Temsirolimus in Patients With Relapsed or Refractory Mantle Cell Non-Hodgkin's Lymphoma (NHL)
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Mantle Cell Lymphoma
Intervention  ICMJE
  • Drug: Temsirolimus
    Temsirolimus 75mg i.v. day 1, 8, 15, 21 for a 28 day cycle with a maximum of 6 Cycles.
    Other Name: Torisel®
  • Drug: Bendamustine
    Bendamustin 90mg/m2 i.v. day 2 and 3 for a 28 day cycle with a maximum of 6 Cycles.
  • Drug: Temsirolimus
    Consolidation Therapy for Patients reached CR or PR with Temsirolimus 75mg weekly until progression.
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Estimated Enrollment  ICMJE
 (submitted: July 26, 2010)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2014
Estimated Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01170052
Other Study ID Numbers  ICMJE EudraCT-No.: 2009-014844-13
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Principal Investigator: Christian Scholz, PD Dept. of Hematology, Charité Berlin, Germany, Charite University, Berlin, Germany
Study Sponsor  ICMJE Charite University, Berlin, Germany
Collaborators  ICMJE
  • Wyeth is now a wholly owned subsidiary of Pfizer
  • Mundipharma K.K.
Investigators  ICMJE
Principal Investigator:Christian Scholz, PD Dr.Charite University, Berlin, Germany
PRS Account Charite University, Berlin, Germany
Verification Date June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP