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

NCT01170052 | Withdrawn Phase 1

• 1 other identifier: EudraCT-No.: 2009-014844-13
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

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.

Conditions

Mantle Cell Lymphoma

Keywords

Relapsed Mantle Cell Lymphoma; Refractory Mantle Cell Lymphoma; Non-Hodgkins Lymphoma; Temsirolimus; Bendamustine; Phase 1/2

Outcome Measures

Primary Outcomes (2)

• 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.

  6 months

• Phase II: Response Rate (Overall response rate, complete and partial response)

  What is the response rate of a therapy with temsirolimus and bendamustine.

  6 months

Secondary Outcomes (2)

• Progression free survival

  2 years

• Safety and Tolerability of Temsirolimus and Bendamustine Combination Therapy

  2 years

Interventions

Temsirolimus DRUG

Temsirolimus 75mg i.v. day 1, 8, 15, 21 for a 28 day cycle with a maximum of 6 Cycles.

Also known as: Torisel®

Bendamustine DRUG

Bendamustin 90mg/m2 i.v. day 2 and 3 for a 28 day cycle with a maximum of 6 Cycles.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• Wyeth is now a wholly owned subsidiary of Pfizer: collaborator
• Mundipharma K.K.: collaborator

Study Sites (3)

Dept. of Hematology and Oncology, Charité, Campus Charité Mitte

Berlin, State of Berlin, 10117, Germany

Location

Dept. of Hematology and Oncology, Charité, Campus Benjamin Franklin

Berlin, State of Berlin, 12203, Germany

Location

Dept. of Hematology and Oncology, Charité, Campus Virchow Klinikum Charité

Berlin, State of Berlin, 13353, Germany

Location

MeSH Terms

Conditions

Lymphoma, Mantle-Cell; Lymphoma, Non-Hodgkin

Interventions

temsirolimus; Bendamustine Hydrochloride

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Christian Scholz, PD Dr.

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 14, 2010
• First Posted: July 27, 2010
• Study Start: May 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2014
• Last Updated: March 16, 2011

Record last verified: 2010-06

Locations

DE (3)