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This study has been withdrawn prior to enrollment.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
  Purpose

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.


Condition Intervention Phase
Mantle Cell Lymphoma
Drug: Temsirolimus
Drug: Bendamustine
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 20
Study Start Date: May 2010
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01170052

Locations
Germany
Dept. of Hematology and Oncology, Charité, Campus Virchow Klinikum Charité
Berlin, Germany, 13353
Dept. of Hematology and Oncology, Charité, Campus Benjamin Franklin
Berlin, Germany, 12203
Dept. of Hematology and Oncology, Charité, Campus Charité Mitte
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
Wyeth is now a wholly owned subsidiary of Pfizer
Mundipharma K.K.
Investigators
Principal Investigator: Christian Scholz, PD Dr. Charite University, Berlin, Germany
  More Information

No publications provided

Responsible Party: Principal Investigator: Christian Scholz, PD Dept. of Hematology, Charité Berlin, Germany, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01170052     History of Changes
Other Study ID Numbers: EudraCT-No.: 2009-014844-13
Study First Received: July 14, 2010
Last Updated: March 15, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Charite University, Berlin, Germany:
Relapsed Mantle Cell Lymphoma
Refractory Mantle Cell Lymphoma
Non-Hodgkins Lymphoma
Temsirolimus
Bendamustine
Phase 1/2

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Bendamustine
Nitrogen Mustard Compounds
Sirolimus
Everolimus
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on July 22, 2014