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

This study has been withdrawn prior to enrollment.
(insufficient enrollment)
Sponsor:
Collaborators:
Wyeth is now a wholly owned subsidiary of Pfizer
Mundipharma K.K.
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01170052
First received: July 14, 2010
Last updated: March 15, 2011
Last verified: June 2010

July 14, 2010
March 15, 2011
May 2010
April 2012   (final data collection date for primary outcome measure)
  • Phase I: Dose-finding [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    What is the response rate of a therapy with temsirolimus and bendamustine.
Same as current
Complete list of historical versions of study NCT01170052 on ClinicalTrials.gov Archive Site
  • Progression free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Detection of overall toxicity, serious adverse events (SAE), suspected unexpected serious adverse reactions (SUSAR) during treatment with temsirolimus and bendamustine.
Same as current
Not Provided
Not Provided
 
Bendamustine and Temsirolimus in Patients With Relapsed or Refractory Mantle Cell Non-Hodgkin's Lymphoma (NHL)
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

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.

Not Provided
Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Mantle Cell Lymphoma
  • 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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
20
April 2014
April 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01170052
EudraCT-No.: 2009-014844-13
No
Principal Investigator: Christian Scholz, PD Dept. of Hematology, Charité Berlin, Germany, Charite University, Berlin, Germany
Charite University, Berlin, Germany
  • Wyeth is now a wholly owned subsidiary of Pfizer
  • Mundipharma K.K.
Principal Investigator: Christian Scholz, PD Dr. Charite University, Berlin, Germany
Charite University, Berlin, Germany
June 2010

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