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

NCT01686321 | Completed Phase 2 DMC

• 2 other identifiers: DSHNHL-2010-12010-024004-98
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Aggressive Lymphoma

Keywords

elderly patients; bendamustine

Outcome Measures

Primary Outcomes (5)

• Progression-free survival

  2 years

• adverse events (AE)'s

  up to 30 days after last study drug administration

• serious adverse events (SAE)'s

  up to 30 days after last study drug administration

• rate of therapy-associated deaths

  up to 30 days after last study drug administration

• protocol adherence

  18 weeks after start of therapy

Secondary Outcomes (8)

• CR rate

  2 years

• PR rate

  2 years

• rate of primary progression

  2 years

• relapse rate

  2 years

• event-free survival

  2 years

Study Arms (1)

Bendamustine and subcutaneous Rituximab

EXPERIMENTAL

single-arm non randomized

Drug: Bendamustine and subcutaneous rituximab

Interventions

Bendamustine and subcutaneous rituximab DRUG

Bendamustine and subcutaneous Rituximab

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Prof. Trümper

Göttingen, 37075, Germany

Location

MeSH Terms

Interventions

Bendamustine Hydrochloride

Intervention Hierarchy (Ancestors)

Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Lorenz Trümper, Prof

  University medicine Goettingen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: July 30, 2012
• First Posted: September 18, 2012
• Study Start: July 4, 2012
• Primary Completion: August 8, 2018
• Study Completion: August 8, 2018
• Last Updated: December 31, 2018

Record last verified: 2018-12

Locations

DE (1)