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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00004179
Registration number
NCT00004179
Ethics application status
Date submitted
21/01/2000
Date registered
27/01/2003
Date last updated
15/02/2021
Titles & IDs
Public title
Combination Chemotherapy With or Without Rituximab in Treating Patients With Relapsed Non-Hodgkin's Lymphoma
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Scientific title
Chimeric Anti-CD20 Monoclonal Antibody (Mabthera) in Remission Induction and Maintenance Treatment of Relapsed Follicular Non-Hodgkin's Lymphoma: A Phase III Randomized Clinical Trial - Intergroup Collaborative Study
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Secondary ID [1]
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0
EORTC-20981
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Secondary ID [2]
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EORTC-20981
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Lymphoma
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Condition category
Condition code
Cancer
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0
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
0
0
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0
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Response to treatment
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Assessment method [1]
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Timepoint [1]
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Secondary outcome [1]
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Overall survival
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Assessment method [1]
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Timepoint [1]
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from randomization
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Secondary outcome [2]
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Progression Free survival
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Assessment method [2]
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Timepoint [2]
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from randomization
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Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:
* Histologically or cytologically proven stage III or IV follicular non-Hodgkin's lymphoma (NHL)
* Relapsed after or no response (no change/progressive disease) to no more than 2 adequate non-anthracycline-containing systemic chemotherapy regimens
* At least 2 months of single-agent therapy (e.g., chlorambucil) AND/OR
* At least 2 consecutive courses of polychemotherapy (e.g., cyclophosphamide, vincristine, and prednisone) or purine analogues
* Complete or partial remission or no change for at least 4 weeks after completion of prior therapy OR progression during one of a maximum of 2 prior therapy regimens
* CD20 positive
* At least 1 bidimensionally measurable mass
* No greater than 10,000,000/mL circulating tumor cells
* IgG levels at least 3 g/L
* No low-grade NHL transformed into intermediate- or high-grade NHL
* No symptomatic CNS lymphoma
* No bone marrow involvement only NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* WHO 0-2
Life expectancy:
* Not specified
Hematopoietic:
* Not specified
Hepatic:
* Bilirubin less than 2.5 times upper limit of normal (ULN)
* Alkaline phosphatase less than 2.5 times ULN
Renal:
* Creatinine less than 2.5 times ULN
* BUN less than 2.5 times ULN
Cardiovascular:
* No severe cardiac disease (i.e., severe heart failure requiring symptomatic treatment)
Pulmonary:
* No severe pulmonary disease
Other:
* No severe neurologic or psychiatric disease
* No severe metabolic disease
* Not pregnant
* Fertile patients must use effective contraception
* No prior malignancy within the past 5 years except nonmelanomatous skin cancer, carcinoma in situ of the cervix, or other cancer curatively treated with surgical therapy
* HIV negative
* No uncontrolled asthma or allergy requiring steroids
* No known hypersensitivity or prior anaphylactic reaction to murine proteins or any component of study drug
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No prior rituximab
* No prior allogeneic or autologous peripheral blood stem cell transplantation
* Concurrent filgrastim (G-CSF) for stem cell mobilization allowed
Chemotherapy:
* See Disease Characteristics
* No prior anthracyclines or mitoxantrone
* No concurrent chemotherapy for stem cell mobilization
Endocrine therapy:
* Not specified
Radiotherapy:
* Not specified
Surgery:
* Not specified
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Minimum age
18
Years
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Maximum age
120
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Intervention assignment
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/05/1999
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
19/07/2017
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Sample size
Target
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Accrual to date
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Final
475
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,VIC,WA
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Recruitment hospital [1]
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Canberra Hospital - Garran
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Concord Repatriation General Hospital - Concord
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Cancer Therapy Centre at Liverpool Hospital - Liverpool
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Institute of Oncology at Prince of Wales Hospital - Randwick
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Prince of Wales Private Hospital - Randwick
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Royal North Shore Hospital - St. Leonards
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Recruitment hospital [7]
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St. Vincent's Hospital - Sydney
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Sydney Cancer Centre at Royal Prince Alfred Hospital - Sydney
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St. George Hospital and Community Health Service - Sydney
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Westmead Breast Centre at NSW Breast Cancer Institute - Westmead
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Westmead Hospital - Westmead
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Wollongong Hospital - Wollongong
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Wesley Medical Centre - Auchenflower
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Royal Brisbane and Women's Hospital - Brisbane
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Princess Alexandra Hospital - Brisbane
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Greenslopes Private Hospital - Greenslopes
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Townsville General Hospital - Townsville
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Royal Adelaide Hospital Cancer Centre - Adelaide
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Ashford Cancer Centre - Ashford
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Flinder Medical Centres - Bedford Park
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Queen Elizabeth Hospital - Woodville
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Royal Hobart Hospital - Hobart
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St. John of God Hospital - Ballarat
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Box Hill Hospital - Box Hill
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John Fawkner Hospital - Coburg
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Peter MacCallum Cancer Centre - East Melbourne
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St. Vincent's Hospital - Fitzroy
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Frankston Hospital - Frankston
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Geelong Hospital - Geelong
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Austin Hospital - Heidelberg
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Alfred Hospital - Melbourne
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Garden Consulting Rooms - Mornington
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Royal Melbourne Hospital - Parkville
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Mount Medical Centre - Perth
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Royal Perth Hospital - Perth
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Sir Charles Gairdner Hospital - Perth - Perth
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Recruitment postcode(s) [1]
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2605 - Garran
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2139 - Concord
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2170 - Liverpool
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2031 - Randwick
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NSW 2031 - Randwick
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Recruitment postcode(s) [6]
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2065 - St. Leonards
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2010 - Sydney
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2050 - Sydney
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2217 - Sydney
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2145 - Westmead
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2500 - Wollongong
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4066 - Auchenflower
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4029 - Brisbane
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4102 - Brisbane
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4120 - Greenslopes
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4810 - Townsville
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5000 - Adelaide
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5035 - Ashford
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5042 - Bedford Park
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5011 - Woodville
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7000 - Hobart
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3350 - Ballarat
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3128 - Box Hill
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3058 - Coburg
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8006 - East Melbourne
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3065 - Fitzroy
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3199 - Frankston
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3200 - Geelong
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Recruitment postcode(s) [29]
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3084 - Heidelberg
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Recruitment postcode(s) [30]
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3181 - Melbourne
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3931 - Mornington
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3050 - Parkville
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6160 - Fremantle
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6000 - Perth
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6009 - Perth
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Recruitment outside Australia
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Belgium
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Antwerp
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Trondheim
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Lisbon
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Bratislava
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Ljubljana
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Brooklyn Square
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South Africa
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Johannesburg
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Parktown
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Sweden
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Linkoping
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Lulea
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Lund
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Orebro
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Sundsvall
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Sweden
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Umea
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United Kingdom
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England
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Northern Ireland
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Wales
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Chichester
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Hull
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Kettering, Northants
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United Kingdom
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Stafford
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United Kingdom
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Swindon,
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Funding & Sponsors
Primary sponsor type
Other
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Name
European Organisation for Research and Treatment of Cancer - EORTC
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Other
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Lymphoma Trials Office
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Other
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Stichting Hemato-Oncologie voor Volwassenen Nederland
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Other
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Australasian Leukaemia and Lymphoma Group
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Other
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NCIC Clinical Trials Group
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Other
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Nordic Lymphoma Group
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Ethics approval
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Summary
Brief summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. It is not yet known whether chemotherapy is more effective with or without rituximab for relapsed non-Hodgkin's lymphoma. PURPOSE: This randomized phase III trial is studying combination chemotherapy and rituximab to see how well they work compared to combination chemotherapy alone in treating patients with relapsed non-Hodgkin's lymphoma.
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Trial website
https://clinicaltrials.gov/study/NCT00004179
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Trial related presentations / publications
Deconinck E, Miadi-Fargier H, Pen CL, Brice P. Cost effectiveness of rituximab maintenance therapy in follicular lymphoma: long-term economic evaluation. Pharmacoeconomics. 2010;28(1):35-46. doi: 10.2165/11314070-000000000-00000. Pompen M, Huijgens PC, et al.: Cost-effectiveness of rituximab for maintenance in patients with follicular non-Hodgkin's lymphoma in the Dutch setting. [Abstract] Blood 112 (11): A-2364, 2008. Van Oers MH, Hagenbeek A, Van Glabbeke M, Teodorovic I. Chimeric anti-CD20 monoclonal antibody (Mabthera) in remission induction and maintenance treatment of relapsed follicular non-Hodgkin's lymphoma: a phase III randomized clinical trial--Intergroup Collaborative Study. Ann Hematol. 2002 Oct;81(10):553-7. doi: 10.1007/s00277-002-0548-2. Epub 2002 Oct 17. No abstract available. van Oers MH, Tonnissen E, Van Glabbeke M, Giurgea L, Jansen JH, Klasa R, Marcus RE, Wolf M, Kimby E, Vranovsky A, Holte H, Hagenbeek A, van der Reijden BA. BCL-2/IgH polymerase chain reaction status at the end of induction treatment is not predictive for progression-free survival in relapsed/resistant follicular lymphoma: results of a prospective randomized EORTC 20981 phase III intergroup study. J Clin Oncol. 2010 May 1;28(13):2246-52. doi: 10.1200/JCO.2009.25.0852. Epub 2010 Apr 5. van Oers MH, Van Glabbeke M, Giurgea L, Klasa R, Marcus RE, Wolf M, Kimby E, van t Veer M, Vranovsky A, Holte H, Hagenbeek A. Rituximab maintenance treatment of relapsed/resistant follicular non-Hodgkin's lymphoma: long-term outcome of the EORTC 20981 phase III randomized intergroup study. J Clin Oncol. 2010 Jun 10;28(17):2853-8. doi: 10.1200/JCO.2009.26.5827. Epub 2010 May 3. van Oers MH, Klasa R, Marcus RE, Wolf M, Kimby E, Gascoyne RD, Jack A, Van't Veer M, Vranovsky A, Holte H, van Glabbeke M, Teodorovic I, Rozewicz C, Hagenbeek A. Rituximab maintenance improves clinical outcome of relapsed/resistant follicular non-Hodgkin lymphoma in patients both with and without rituximab during induction: results of a prospective randomized phase 3 intergroup trial. Blood. 2006 Nov 15;108(10):3295-301. doi: 10.1182/blood-2006-05-021113. Epub 2006 Jul 27. Mattiola I, Mantovani A, Locati M. The tetraspan MS4A family in homeostasis, immunity, and disease. Trends Immunol. 2021 Sep;42(9):764-781. doi: 10.1016/j.it.2021.07.002. Epub 2021 Aug 9.
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Public notes
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Contacts
Principal investigator
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M. H. J. Van Oers, MD
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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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No information has been provided regarding IPD availability
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Results publications and other study-related documents
Type
Citations or Other Details
Journal
van Oers MH, Tonnissen E, Van Glabbeke M, Giurgea ...
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Journal
van Oers MH, Van Glabbeke M, Giurgea L, Klasa R, M...
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Journal
van Oers MH, Klasa R, Marcus RE, Wolf M, Kimby E, ...
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Results not provided in
https://clinicaltrials.gov/study/NCT00004179
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