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

December 27, 2018 updated by: Lorenz, Trümper, MD, University of Göttingen

Subcutaneous Rituximab and Intravenous Bendamustine in Very Elderly Patients or Elderly Medically Non Fit Patients ("Slow Go") With Aggressive CD20-positive B-cell

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
68

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Göttingen, Germany, 37075
        • Prof. Trümper

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Bendamustine and subcutaneous Rituximab
single-arm non randomized
Drug: Bendamustine and subcutaneous rituximab

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Progression-free survival
Time Frame: 2 years
2 years
adverse events (AE)'s
Time Frame: up to 30 days after last study drug administration
up to 30 days after last study drug administration
serious adverse events (SAE)'s
Time Frame: up to 30 days after last study drug administration
up to 30 days after last study drug administration
rate of therapy-associated deaths
Time Frame: up to 30 days after last study drug administration
up to 30 days after last study drug administration
protocol adherence
Time Frame: 18 weeks after start of therapy
18 weeks after start of therapy

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Quality of life
Time Frame: 2 years
2 years
overall survival
Time Frame: 2 years
2 years
event-free survival
Time Frame: 2 years
2 years
CR rate
Time Frame: 2 years
2 years
PR rate
Time Frame: 2 years
2 years
rate of primary progression
Time Frame: 2 years
2 years
relapse rate
Time Frame: 2 years
2 years
Comprehensive Geriatric Assessment
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Göttingen

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Roche Pharma AG
Mundipharma Research GmbH & Co KG

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lorenz Trümper, Prof, University Medicine Goettingen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 4, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 8, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 8, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 30, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 18, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 31, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 27, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DSHNHL-2010-1
  • 2010-024004-98 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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