Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01686321
Recruitment Status : Completed
First Posted : September 18, 2012
Last Update Posted : December 31, 2018
Sponsor:
Collaborators:
Roche Pharma AG
Mundipharma Research GmbH & Co KG
Information provided by (Responsible Party):
Lorenz, Trümper, MD, University of Göttingen

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment Phase
Aggressive Lymphoma Drug: Bendamustine and subcutaneous rituximab Phase 2

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.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Actual Study Start Date : July 4, 2012
Actual Primary Completion Date : August 8, 2018
Actual Study Completion Date : August 8, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Bendamustine and subcutaneous Rituximab
single-arm non randomized
 Drug: Bendamustine and subcutaneous rituximab


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: 2 years ]
  2. adverse events (AE)'s [ Time Frame: up to 30 days after last study drug administration ]
  3. serious adverse events (SAE)'s [ Time Frame: up to 30 days after last study drug administration ]
  4. rate of therapy-associated deaths [ Time Frame: up to 30 days after last study drug administration ]
  5. protocol adherence [ Time Frame: 18 weeks after start of therapy ]

Secondary Outcome Measures :
  1. CR rate [ Time Frame: 2 years ]
  2. PR rate [ Time Frame: 2 years ]
  3. rate of primary progression [ Time Frame: 2 years ]
  4. relapse rate [ Time Frame: 2 years ]
  5. event-free survival [ Time Frame: 2 years ]
  6. overall survival [ Time Frame: 2 years ]
  7. Quality of life [ Time Frame: 2 years ]
  8. Comprehensive Geriatric Assessment [ Time Frame: 2 years ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01686321


Locations
Layout table for location information
Germany
Prof. Trümper
Göttingen, Germany, 37075
Sponsors and Collaborators
University of Göttingen
Roche Pharma AG
Mundipharma Research GmbH & Co KG
Investigators
Layout table for investigator information
Principal Investigator: Lorenz Trümper, Prof University medicine Goettingen
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Lorenz, Trümper, MD, Prof. Dr., University of Göttingen
ClinicalTrials.gov Identifier: NCT01686321    
Other Study ID Numbers: DSHNHL-2010-1
2010-024004-98 ( EudraCT Number )
First Posted: September 18, 2012    Key Record Dates
Last Update Posted: December 31, 2018
Last Verified: December 2018
Keywords provided by Lorenz, Trümper, MD, University of Göttingen:
elderly patients
bendamustine
Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphoma
Aggression
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Behavioral Symptoms
Rituximab
 Bendamustine Hydrochloride
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action