Treatment of Patients With Diffuse Large B Cell Lymphoma Who Are Not Suitable for Anthracycline Containing Chemotherapy
- Conditions
- Diffuse Large B Cell Lymphoma
- Interventions
- Registration Number
- NCT01679119
- Lead Sponsor
- University College, London
- Brief Summary
The purpose of this trial is to compare the efficacy and safety of Inotuzumab Ozogamicin in combination with R-CVP with that of R-G-CVP for the treatment of Diffuse Large B Cell Lymphoma (DLBCL) in a population of patients not suitable for anthracycline based chemotherapy.
There is no standard of care for the treatment of this group of patients. If demonstrated to be efficacious and safe to deliver this regimen will be further tested in a phase III trial to determine whether this should become the standard of care amongst patients with DLBCL not fit for anthracycline (R-CHOP).
- Detailed Description
The incidence of DLBCL is increasing and with an expanding elderly population, the incidence will continue to rise. Given that about 40% of cases of DLBCL occur in patients aged over 70 and the number of co-mobilities increases with age, research to investigate the optimal treatment of DLBCL in this group of patients is needed. R-CHOP remains the standard of care for the majority of patients with DLBCL, anthracycline use is precluded in a proportion of these patients by a high risk of developing cardiotoxicity, especially congestive cardiac failure. Currently there is no standard of care for patients who are unfit for anthracycline treatment. It has been routine to omit the doxorubicin from R-CHOP, giving R-CVP instead. However the outcome for patients treated with R-CVP is poor and attempts have been made to replace the doxorubicin with alternative agents. The trial will compare an experimental arm consisting of Inotuzumab Ozogamicin added to the standard immunochemotherapy regimen of rituximab, cyclophosphamide, vincristine and prednisolone (R-CVP) with the control arm of gemcitabine added to the same combination (Gem-R-CVP).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 129
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description IO-R-CVP Inotuzumab Ozogamicin Inotuzumab Ozogamicin plus Rituximab and CVP (Cyclophosphamide, vincristine \& prednisolone). IO-R-CVP Rituximab Inotuzumab Ozogamicin plus Rituximab and CVP (Cyclophosphamide, vincristine \& prednisolone). IO-R-CVP Vincristine Inotuzumab Ozogamicin plus Rituximab and CVP (Cyclophosphamide, vincristine \& prednisolone). IO-R-CVP Cyclophosphamide Inotuzumab Ozogamicin plus Rituximab and CVP (Cyclophosphamide, vincristine \& prednisolone). IO-R-CVP Prednisolone Inotuzumab Ozogamicin plus Rituximab and CVP (Cyclophosphamide, vincristine \& prednisolone). Gem-R-CVP Cyclophosphamide Gemcitabine plus Rituximab and CVP (Cyclophosphamide, Vincristine and Prednisolone). Gem-R-CVP Vincristine Gemcitabine plus Rituximab and CVP (Cyclophosphamide, Vincristine and Prednisolone). Gem-R-CVP Rituximab Gemcitabine plus Rituximab and CVP (Cyclophosphamide, Vincristine and Prednisolone). Gem-R-CVP Prednisolone Gemcitabine plus Rituximab and CVP (Cyclophosphamide, Vincristine and Prednisolone). Gem-R-CVP Gemcitabine Gemcitabine plus Rituximab and CVP (Cyclophosphamide, Vincristine and Prednisolone).
- Primary Outcome Measures
Name Time Method Progression free survival At 2 years following date of randomisation. Progression free survival rate and will be analysed using Kaplan-Meier survival analysis. PFS time will be measured from date of randomisation until progression or death.
- Secondary Outcome Measures
Name Time Method Treatment toxicity 7 months from beginning of treatment During treatment and follow up visits
Instrumental Activities of Daily Living of patients during and after treatment Baseline, during treatment and 6 month and 2 year follow up Instrumental Activities of Daily Living questionnaire (IADL) to be completed by patient at time points listed below (8 questions about ability to undertake daily activities/self-care)
Co-morbidities of patients Baseline Details of co-morbidities to be recorded at point of randomisation by investigator
Overall response rate Approximately 6 months after treatment start At the end of treatment
Overall Survival 5 years from date of registration Date of registration until death.
Quality of life of patients during and after treatment Baseline, during treatment and 6 month and 2 year follow up QoL questionnaires (EORTC QLQ-C30; Quality of life of cancer patients; 30 questions) to be completed by patient at time points listed below
Activities of Daily Living of patients during and after treatment Baseline, during treatment and 6 month and 2 year follow up Activities of Daily Living questionnaire (ADL) to be completed by patient at time points listed below (6 questions about ability to undertake self-care)
Performance status post treatment Baseline, every 21 days for 8 cycles, 5 1/2 months at the end of treatment and then up to 3 years after the end of treatment. Performance status to be measured by investigator at time points listed below
Trial Locations
- Locations (40)
Stoke Mandeville Hospital (including Wycombe Hospital)
🇬🇧Aylesbury, United Kingdom
North Hampshire Hospital
🇬🇧Basingstoke, United Kingdom
Royal United Hospital
🇬🇧Bath, United Kingdom
Royal Bournemouth Hospital
🇬🇧Bournemouth, United Kingdom
Bristol Oncology Centre
🇬🇧Bristol, United Kingdom
West Suffolk Hospital
🇬🇧Bury St Edmunds, United Kingdom
Kent and Canterbury Hospital
🇬🇧Canterbury, United Kingdom
Castle Hill Hospital
🇬🇧Cottingham, United Kingdom
University Hospital, Coventry
🇬🇧Coventry, United Kingdom
Darent Valley Hospital
🇬🇧Dartford, United Kingdom
Scroll for more (30 remaining)Stoke Mandeville Hospital (including Wycombe Hospital)🇬🇧Aylesbury, United Kingdom