Treatment of Patients With Diffuse Large B Cell Lymphoma Who Are Not Suitab... | Recruiting
Treatment of Patients With Diffuse ... | Recruiting
Treatment of Patients With Diffuse Large B Cell Lymphoma Who Are Not Suitable for Anthracycline Containing Chemotherapy
INCA

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Medical Conditions
  • Diffuse Large B Cell Lymphoma
Primary Contact Details
INCA Trial Coordinator
+ 44 2076799860
See all trial contact details
Recruitment Status
Recruiting
Trial source and source ID number
NCT01679119
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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).
Research Details
  • 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).
Phase
Phase 2
Study Design
Sorry, this information is not available
Study Type
Interventional
Intervention
Drug : Cyclophosphamide, Drug : Vincristine, Drug : Prednisolone, Drug : Rituximab, Drug : Inotuzumab Ozogamicin, Drug : Gemcitabine

Study Arm Groups : IO-R-CVP, Gem-R-CVP, IO-R-CVP, Gem-R-CVP, IO-R-CVP, Gem-R-CVP, IO-R-CVP, Gem-R-CVP, IO-R-CVP, Gem-R-CVP

Intervention Type
See Interventions above
Primary Outcome Measures
    Progression free survival; At 2 years following date of randomisation.
Secondary Outcome Measures
    Overall response rate; Approximately 6 months after treatment start; Overall Survival; 5 years from date of registration; Treatment toxicity; 7 months from beginning of treatment; Quality of life; Baseline, during treatment and 6 month and 2 year follow up; 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.; Co-morbidities of patients; Baseline
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
All
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
132
Participant Inclusion Criteria
    Inclusion criteria:

    - Informed written consent for the trial

    - Histologically proven diffuse large B cell lymphoma (DLBCL) according to the current World Health Organisation (WHO) classification including all morphological variants. The B cell nature of the proliferation must be verified by demonstration of CD20 positivity. A concurrent (synchronous) diagnosis of low grade lymphoma (e.g. on bone marrow trephine or presence of both low grade and DLBCL in a lymph node biopsy) or previous diagnosis of low grade lymphoma which hasn't been treated with a systemic therapy is permitted

    - Bulky Stage IA (lymph node or lymph node mass ≥ 10cm in maximum diameter), stage IB, stage II, stage III and stage IV disease

    - ECOG performance status 0-2

    - Measurable disease

    - Age 18 ≥ years

    - Adequate contraceptive precautions for all patients of childbearing potential

    - History of malignant disease diagnosed at any time in the past with completed radical treatment and the risk of relapsing within the next 5 years is <10%. Patients previously treated should be free of sequelae of treatment which would compromise the delivery of study drugs as compared with other eligible patients.

    - No previous chemotherapy, radiotherapy or other investigational drug for this indication - previous corticosteroids up to a dose equivalent to prednisolone 1mg/kg/day for up to 14 days are permitted prior to randomisation EITHER

    - Unsuitable for anthracycline-containing chemotherapy due to impaired cardiac function defined by an ejection fraction of ≤ 50% OR Left ventricle ejection fraction > 50% but in the presence of significant co-morbidities (diabetes mellitus, hypertension or ischaemic heart disease) precluding anthracycline-containing chemotherapy as determined by treating physician. Co-morbidities must be documented on the randomisation form and CIRS score recorded

    - Adequate bone marrow function (Platelets > 100x109/l, WBC > 3.0x109/l, Neutrophils > 1.5x109/l) at time of study entry unless attributed to bone marrow infiltration by DLBCL

    - Life expectancy > 3 months

    Exclusion criteria:

    - Symptomatic central nervous system or meningeal involvement by DLBCL

    - Previous diagnosis of low grade lymphoma which has been treated with a systemic therapy

    - Non-bulky stage IA disease

    - ECOG performance status 3-4

    - History of chronic liver disease or suspected alcohol abuse

    - Serum bilirubin greater than upper limit of normal unless attributable to Gilberts syndrome or haemolysis

    - Alanine and/or aspartate aminotransferase levels (ALT and/or AST) and alkaline phosphatase (ALP) greater than 2.5 times the upper limit of normal

    - Glomerular filtration rate (GFR) < 30ml/min. GFR calculated by Cockroft-Gault (not eGFR).

    - Serological evidence of active hepatitis B or C infection whether acute or chronic (defined as positive anti-HCV serology; positive HBsAg). All positive HBcAb results should also be excluded on safety grounds regardless of HBsAg or HBV DNA status. Antibodies to Hepatitis B surface antigen (anti-HBs) due to a history of past vaccination is acceptable

    - Known history of HIV seropositive status

    - Patients with a history of Venoocclusive Disease (VOD) and Sinusoidal Obstructive Syndrome (SOS)

    - Patients with a screening of QTcF interval >470msec

    - Medical or psychiatric conditions compromising the patient's ability to give informed consent

    - Women who are pregnant or lactating

    - LVEF > 50% in the absence of significant co-morbidities that preclude anthracycline use

    - Patients with a history of severe allergic/anaphylactic reaction to any humanised monoclonal antibody

    - Patients with serious active infection
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Local Institution
Glasgow
Central
Local Institution
Plymouth
Devon
Local Institution
London
Greater London
Local Institution
Oxford
Oxfordshire
Manchester
Harrow
Heart & Chest Hospital
Liverpool
Local Institution
Newcastle upon Tyne
Tyne and Wear
Oldfield Surgery
Bath
Greenwood Medical Center
Nottingham
Brook Lane Surgery
Southampton
Leeds
Truro
Cornwall
Norfolk and Norwich University Hospital
Norwich
Hull Clinical Trials Unit
Cottingham
East Yorkshire
Uni Hospital Leicester
Leicester
Bristol
University Hospital
Coventry
Torquay
Exeter
Kettering
Stoke Mandeville Hospital and Wycombe Hospital
Aylesbury
North Hampshire & Basingstoke Hospital
Basingstoke
Royal Bournemouth
Bournemouth
Darent Valley Hospital
Dartford
Medway Maritime Hospital
Gillingham
Kent and Canterbury Hospital
Kent
Luton and Dunstable Hospital
Luton
Queen's Hospital
Romford
Worcestershire Royal Hospital
Worcester
Princess Royal Hospital
Orpington
Kent
Teva Investigational Site 34064
Bury Saint Edmunds
Teva Investigational Site 34119
Great Yarmouth
North Shields
Research Site
Winchester
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Wythenshawe
Manchester
King's Mill Hospital
Sutton-in-Ashfield
England
Trial Contact(s)
Primary Trial Contact
INCA Trial Coordinator
+ 44 2076799860
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
A Randomised Phase II Trial of Inotuzumab Ozogamicin Plus Rituximab & CVP (IO-R-CVP) vs Gemcitabine Plus Rituximab & CVP (Gem-R-CVP) for the First Line Treatment of Patients With DLBCL Who Are Not Suitable for Anthracycline Containing Chemotherapy
EudraCT Number
Not available for this trial
Funder(s)
  • Pfizer
  • Cancer Research UK
Other Study ID Numbers
UCL 11/0475
Sponsor(s)
University College, London
Key Dates

Recruitment Start Date

Oct 2013

Recruitment End Date

Oct 2017

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

23 Jul 2012

Date updated in source

03 May 2017