Aggressive LymphomaPhase 2B-R-ENDANCT01686321
Rituximab and Bendamustine in Very Elderly Patients or Elderly Medically Non Fit Patients With Aggressive B-cell Lymphoma
A Phase 2 study testing Bendamustine and subcutaneous rituximab in people with Aggressive Lymphoma, run by University of Göttingen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Aggressive Lymphoma
- What is being tested?
- Bendamustine and subcutaneous rituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteGermany
- Study dates
- 4 Jul 2012to 8 Aug 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Aggressive Lymphoma
- Being tested
- Bendamustine and subcutaneous rituximab
- Keywords
- elderly patients, bendamustine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bendamustine and subcutaneous rituximabDrug
| Study group | Role | What they receive |
|---|---|---|
| Bendamustine and subcutaneous Rituximab | Experimental | single-arm non randomized Receives: Drug: Bendamustine and subcutaneous rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Measured: 2 years
adverse events (AE)'s
Measured: up to 30 days after last study drug administration
serious adverse events (SAE)'s
Measured: up to 30 days after last study drug administration
rate of therapy-associated deaths
Measured: up to 30 days after last study drug administration
protocol adherence
Measured: 18 weeks after start of therapy
Secondary outcomes (8)
CR rate
Measured: 2 years
PR rate
Measured: 2 years
rate of primary progression
Measured: 2 years
relapse rate
Measured: 2 years
event-free survival
Measured: 2 years
overall survival
Measured: 2 years
Quality of life
Measured: 2 years
Comprehensive Geriatric Assessment
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2012 (estimated)
- Study start4 Jul 2012
- Primary completion8 Aug 2018
- Study completion8 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aggressive LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Göttingen
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG, Mundipharma Research GmbH & Co KG
- Responsible party
- Principal investigator, Lorenz, Trümper, MD, University of Göttingen
- Investigators
- Lorenz Trümper, Prof, Principal investigator, University medicine Goettingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01686321
- Sponsor's protocol ID
- DSHNHL-2010-1
- Other IDs
- 2010-024004-98
- Acronym
- B-R-ENDA
- Status last verified
- Dec 2018
- First submitted
- 30 Jul 2012
- Last updated
- 31 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01686321
- Acronym / sponsor ID
- B-R-ENDA / DSHNHL-2010-1
- Conditions
- Aggressive Lymphoma
- Keywords
- elderly patients, bendamustine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University of GöttingenUniversity, hospital or other
- Collaborators
- Roche Pharma AG, Mundipharma Research GmbH & Co KG
- Study start
- 4 Jul 2012 (actual)
- Primary completion
- 8 Aug 2018 (actual)
- Study completion
- 8 Aug 2018 (actual)
- First posted
- 18 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bendamustine and subcutaneous Rituximab | Experimental | Drug: Bendamustine and subcutaneous rituximabsingle-arm non randomized |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bendamustine and subcutaneous rituximab | Drug | Bendamustine and subcutaneous Rituximab |
Primary outcome
Progression-free survival
Time frame: 2 years
adverse events (AE)'s
Time frame: 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
rate of therapy-associated deaths
Time frame: up to 30 days after last study drug administration
protocol adherence
Time frame: 18 weeks after start of therapy
8 secondary outcomes
CR rate
Time frame: 2 years
PR rate
Time frame: 2 years
rate of primary progression
Time frame: 2 years
relapse rate
Time frame: 2 years
event-free survival
Time frame: 2 years
overall survival
Time frame: 2 years
Quality of life
Time frame: 2 years
Comprehensive Geriatric Assessment
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lorenz Trümper, Prof principal investigator
University medicine Goettingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bendamustine and subcutaneous rituximab in people with Aggressive Lymphoma, run by University of Göttingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: 2 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2018.