Very elderly or elderly medically non fit patients with aggressive CD20 positive B-cell lymphoma MedDRA version: 20.0 Level: PT Classification code 10003899 Term: B-cell lymphoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Ribomustin
Product Name: Ribomustin
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: BENDAMUSTINE HYDROCHLORIDE
CAS Number: 3543-75-7
Concentration unit: mg milli
Sponsors
University Medicine Göttingen Dept. Hematology and Oncology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Histologically confirmed CD20 positive aggressive lymphoma, • Aany stage according to Ann Arbor Classification, • Any IPI score, • Life expectancy of at least 6 week at study beginn • Age = 81 (completed) or age 61 to 80 (completed, including time period until the day before the 81st birthday) and CIRS > 6 and not qualifying for CHOP-therapy • Ability to give informed consent • Written informed consent • ECOG =65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: • Already initiated lymphoma therapy (except for the prephase treatment up to the first Rituximab application as specified for this study) • Serious accompanying disorder or impaired organ function (except when due to lymphoma involvement), in particular: • angina pectoris CCS >2, cardiac failure NYHA >3 • FeV1 3 mg/dl • Uncontrollable diabetes mellitus (prephase treatment with prednisolone!) • 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 systemic corticosteroids or anti-neoplastic drugs for previous disorder • Other concomitant tumour disease and/or tumour 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. • Non-conformity to eligibility criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary endpoint for efficacy is the 2 years progression free survival. The primary endpoint for feasibility are therapy-associated deaths, frequency of grade 3&4 adverse events and SAEs, adherence to the protocol (as determined by cumlulative dose and time plot). ;Secondary Objective: 2 year overall survival, event-free survival, complete remission rate, partial remission rate, rate of primary pogression, relapse rate, ability for self-care and quality of life assessed by geriatric assessment and EORTC-QLQ-C30, patient satisfaction (CTQS);Primary end point(s): Primary endpoints for efficacy: 2 years progression free survival (PFS). Primary endpoints for feasibility: therapy-associated deaths, frequency of grade 3&4 adverse events and SAEs, adherence to the protocol (as determined by cumulative dose and time plot) ;Timepoint(s) of evaluation of this end point: Planned evaluation of primary endpoint: 8/2018 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 2 years overall survival (OS), event-free-survival (EFS), complete remission rate (CR) and partial remission rate (PR), rate of primary progression, relapse rate, ability for self-care and quality of life assessed by geriatric assessment and EORTC-QLQ-C30, patient satisfaction (CTQS);Timepoint(s) of evaluation of this end point: Planned evaluation of secondary endpoint: 8/2018 | — |
Countries
Germany
Contacts
Public ContactKristina Wilhelm
iOMEDICO AG
Outcome results
None listed