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

Sponsor
University of Göttingen (Other)
Overall Status
Completed
CT.gov ID
NCT01686321
Collaborator
Roche Pharma AG (Industry), Mundipharma Research GmbH & Co KG (Industry)
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Study Details

Study Description

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
  • 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

Study Type:
Interventional
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 :
Jul 4, 2012
Actual Primary Completion Date :
Aug 8, 2018
Actual Study Completion Date :
Aug 8, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Bendamustine and subcutaneous Rituximab

single-arm non randomized

Drug: Bendamustine and subcutaneous rituximab

Outcome Measures

Primary Outcome Measures

  1. Progression-free survival [2 years]

  2. adverse events (AE)'s [up to 30 days after last study drug administration]

  3. serious adverse events (SAE)'s [up to 30 days after last study drug administration]

  4. rate of therapy-associated deaths [up to 30 days after last study drug administration]

  5. protocol adherence [18 weeks after start of therapy]

Secondary Outcome Measures

  1. CR rate [2 years]

  2. PR rate [2 years]

  3. rate of primary progression [2 years]

  4. relapse rate [2 years]

  5. event-free survival [2 years]

  6. overall survival [2 years]

  7. Quality of life [2 years]

  8. Comprehensive Geriatric Assessment [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Prof. Trümper Göttingen Germany 37075

Sponsors and Collaborators

  • University of Göttingen
  • Roche Pharma AG
  • Mundipharma Research GmbH & Co KG

Investigators

  • Principal Investigator: Lorenz Trümper, Prof, University medicine Goettingen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lorenz, Trümper, MD, Prof. Dr., University of Göttingen
ClinicalTrials.gov Identifier:
NCT01686321
Other Study ID Numbers:
  • DSHNHL-2010-1
  • 2010-024004-98
First Posted:
Sep 18, 2012
Last Update Posted:
Dec 31, 2018
Last Verified:
Dec 1, 2018
Keywords provided by Lorenz, Trümper, MD, Prof. Dr., University of Göttingen
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 31, 2018