Rituximab and Bendamustine in Very Elderly Patients or Elderly Medically Non Fit Patients With Aggressive B-cell Lymphoma (B-R-ENDA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by University of Göttingen
Sponsor:
Collaborators:
Roche Pharma AG
Mundipharma Research GmbH & Co KG
Information provided by (Responsible Party):
Lorenz, Trümper, MD, University of Göttingen
ClinicalTrials.gov Identifier:
NCT01686321
First received: July 30, 2012
Last updated: February 21, 2013
Last verified: February 2013
  Purpose

Bendamustine is a well tolerable and very active agent in the treatment of Non Hodgkin's lymphoma. However, in particular in aggressive B-cell lymphoma, only very few, small studies have investigated the role of bendamustine in the treatment algorithm. The aim of the current B-R-ENDA trial is to investigate efficacy and toxicity of the combination treatment of bendamustine and subcutaneous rituximab in old patients or in elderly patients with high comorbidity who do not qualify for a CHOP like treatment. The results of this study will form the basis of a larger, prospective randomized phase III trial.


Condition Intervention Phase
Aggressive Lymphoma
Drug: Bendamustine and subcutaneous rituximab
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: Subcutaneous Rituximab and Intravenous Bendamustine in Very Elderly Patients or Elderly Medically Non Fit Patients ("Slow Go") With Aggressive CD20-positive B-cell

Resource links provided by NLM:


Further study details as provided by University of Göttingen:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • adverse events (AE)'s [ Time Frame: up to 30 days after last study drug administration ] [ Designated as safety issue: Yes ]
  • serious adverse events (SAE)'s [ Time Frame: up to 30 days after last study drug administration ] [ Designated as safety issue: Yes ]
  • rate of therapy-associated deaths [ Time Frame: up to 30 days after last study drug administration ] [ Designated as safety issue: Yes ]
  • protocol adherence [ Time Frame: 18 weeks after start of therapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • CR rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • PR rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • rate of primary progression [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • relapse rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • event-free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Comprehensive Geriatric Assessment [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: May 2012
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bendamustine and subcutaneous Rituximab
single-arm non randomized
Drug: Bendamustine and subcutaneous rituximab

Detailed Description:

Bendamustine is a well tolerable and very active agent in the treatment of Non Hodgkin's lymphoma. However, in particular in aggressive B-cell lymphoma, only very few, small studies have investigated the role of bendamustine in the treatment algorithm. The aim of the current B-R-ENDA trial is to investigate efficacy and toxicity of the combination treatment of bendamustine and subcutaneous rituximab in old patients or in elderly patients with high comorbidity who do not qualify for a CHOP like treatment. The results of this study will form the basis of a larger, prospective randomized phase III trial.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histology: Diagnosis of aggressive CD20+, confirmed by an excisional biopsy of a lymph node or by a sufficiently extensive biopsy of an extranodal involvement if there is no lymph node involvement. It will be possible to treat the following entities in this study as defined by the new WHO classification of 2008: B-NHL, Follicular lymphoma grade IIIb,DLBCL, not otherwise specified (NOS),common morphologic variants: centroblastic,immunoblastic,anaplastic,rare morphologic variants.DLBCL subtypes/entities:T cell/histiocyte rich large B-cell lymphoma, primary cutaneous DLBCL, leg type, EBV-positive DLBCL of the elderly, DLBCL associated with chronic inflammation, primary mediastinal (thymic) large B-cell lymphoma, intravascular large B-cell lymphoma,ALK-positive large B-cell lymphoma, Plasmoblastic lymphoma, Primary effusion lymphoma, B-cell lymphoma, unclassifiable, with features inter¬mediate between diffuse large B-cell lymphoma and Burkitt lymphoma, B-cell lymphoma, unclassifiable, with features inter¬mediate between diffuse large B-cell lymphoma and Hodgkin lymphoma
  • Stage: Any stages according to Ann Arbor Classification
  • Risk group: All risk groups (IPI 1 to 5)
  • Life expectancy Life expectancy of at least 6 weeks, when lymphoma is treated
  • Age: Age elder than 81 or Age 61 to 80 and CIRS >6 not qualifying for CHOP-therapy
  • Gender: any
  • Performance status: Performance status ECOG 0 - 3. The performance status of each patient is to be assessed at the time of registration which might be after the initiation of pre-phase treatment which, as experience has shown, can result in a significant improvement of the patient´s performance status. A definition of the performance status is provided in Appendix 25.6
  • Ability to give informed consent
  • Written informed consent of the patient
  • Contract of participation signed by the study center and sponsor

Exclusion Criteria:

  • Already initiated lymphoma therapy (except for the prephase treatment until first application of rituximab)
  • Serious accompanying disorder or impaired organ function (except when due to lymphoma involvement), in particular: Heart: angina pectoris CCS >2, cardiac failure NYHA >3; Lungs: the patient is to be excluded if the resultant pulmonary function test shows FEV1<50% or a diffusion capacity <50% of the reference values: Calculated creatinin clearance < 10 ml/min (Cockcroft-Gault); Liver: total bilirubin > 3 mg/dl; Uncontrollable diabetes mellitus (because of prephase treatment with prednisone!)
  • Platelets <100 000/mm3, leukocytes <2500/mm3 (if not due to lymphoma)
  • Known hypersensitivity to the medications to be used
  • HIV-positivity
  • Acute or chronic active hepatitis
  • Poor patient compliance
  • Simultaneous participation in other treatment studies
  • Prior chemo- or radiotherapy, long-term use of corticosteroids or anti-neoplastic drugs for previous disorder
  • Other concomitant tumor disease and/or tumor disease in the past 5 years (except basalioma of the skin and carcinoma in situ)
  • CNS involvement of lymphoma (intracerebral, meningeal, intraspinal)
  • Active serious infections not controlled by oral or intravenous antibiotics or anti-fungal
  • Any medical condition which in the opinion of the investigator places the subject at an unacceptably high risk for toxicities.
  • Non-conformity to eligibility criteria.
  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: NCT01686321

Contacts
Contact: Florian Zettl, MD +49551398546 brenda.studie@med.uni-goettingen.de
Contact: Elke Stitz +49551398546 brenda.studie@med.uni-goettingen.de

Locations
Germany
Prof. Trümper Recruiting
Göttingen, Germany, 37075
Contact: Elke Stitz    +49551398546    brenda.studie@med.uni-goettingen.de   
Contact: Florian Zettl, MD    +49551398546    brenda.studie@med.uni-goettingen.de   
Sub-Investigator: Lorenz Trümper, Prof. Dr.         
Principal Investigator: Florian Zettl, MD         
Sponsors and Collaborators
University of Göttingen
Roche Pharma AG
Mundipharma Research GmbH & Co KG
Investigators
Principal Investigator: Lorenz Trümper, Prof University medicine Goettingen
  More Information

No publications provided

Responsible Party: Lorenz, Trümper, MD, Prof. Dr., University of Göttingen
ClinicalTrials.gov Identifier: NCT01686321     History of Changes
Other Study ID Numbers: DSHNHL-2010-1, 2010-024004-98
Study First Received: July 30, 2012
Last Updated: February 21, 2013
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by University of Göttingen:
elderly patients
bendamustine

Additional relevant MeSH terms:
Aggression
Lymphoma
Behavioral Symptoms
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Bendamustine
Rituximab
Nitrogen Mustard Compounds
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on July 22, 2014