Combination Chemotherapy With or Without Rituximab in Treating Patients Wit... | Not Recruiting
Combination Chemotherapy With or Wi... | Not Recruiting
Combination Chemotherapy With or Without Rituximab in Treating Patients With Relapsed Non-Hodgkin's Lymphoma

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Medical Conditions
  • Lymphoma
Primary Contact Details
Unfortunately contact details are not available for this trial.
Recruitment Status
Not Recruiting
Trial source and source ID number
NCT00004179

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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
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.
Research Details
  • OBJECTIVES:

    - Compare the response rate and quality of remission in patients with relapsed follicular non-Hodgkin's lymphoma treated with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) with or without rituximab.

    - Compare the event-free survival and overall survival of patients treated with these regimens.

    - Determine the effect of rituximab as maintenance therapy on progression-free survival of these patients.

    OUTLINE: This is a randomized, multicenter study.

    - Induction: Patients are randomized to one of two treatment arms. Patients are stratified according to participating center, prior treatment with purine analogues, age, number of prior induction treatments and best response obtained (complete vs partial remission vs no change/progressive disease), time since diagnosis (less than 2 years vs more than 2 years), and bulky disease (less than 10 cm vs greater than 10 cm).

    - Arm I (closed as of 12/20/04): Patients receive induction chemotherapy comprising cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1 and oral prednisone on days 1-5 (CHOP chemotherapy). Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.

    - Arm II: Patients receive CHOP chemotherapy as in arm I. Rituximab IV is administered 1 hour after prednisone and before the IV drugs.

    - Maintenance: Patients who achieve partial or complete remission are then randomized to one of two treatment arms. Patients are stratified according to rituximab administration during induction (yes vs no), quality of the response (complete vs partial remission vs no change/progressive disease), and participating center.

    - Arm I: Patients receive no further therapy.

    - Arm II: Beginning 8 weeks after the last CHOP course, patients receive rituximab IV once every 3 months for up to 2 years in the absence of disease progression or unacceptable toxicity.

    Patients are followed every 3 months for 2 years and then every 4 months thereafter.

    PROJECTED ACCRUAL: A total of 752 patients will be accrued for this study within 6 years.
Phase
Phase 3
Study Design
Allocation: Randomized, Primary Purpose: Treatment
Study Type
Interventional
Intervention
Biological : rituximab, Drug : CHOP regimen, Drug : cyclophosphamide, Drug : doxorubicin hydrochloride, Drug : prednisone, Drug : vincristine sulfate

Study Arm Groups : , , , , ,

Intervention Type
See Interventions above
Primary Outcome Measures
    Response to treatment; null
Secondary Outcome Measures
    Overall survival; from randomization; Progression Free survival; from randomization
Publication(s)
van Oers MH, Tönnissen 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.; 20368567; 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.; 20439641; 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.; 16873669
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
Both
Age Range
18 Years - 120 Years
Who Can Participate
Patients
Number of Participants
Sorry, this information is not available
Participant 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
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)
GSK Investigational Site
Bordesley Green
B9 5SS
Blackpool Victoria Hospital
Blackpool
England
FY3 8NR
St. Helier Hospital
Carshalton
England
SM5 1AA
Royal Devon and Exeter Hospital
Exeter
England
EX2 5DW
Hull Royal Infirmary
Hull
England
HU3 2KZ
Kettering General Hosptial
Kettering
England
NNI6 8UZ
Leicester Royal Infirmary
Leicester
England
LE1 5WW
St. George's Hospital
London
England
SW17 0QT
Mount Vernon Cancer Centre at Mount Vernon Hospital
Northwood
England
HA6 2RN
Rosemere Cancer Centre at Royal Preston Hospital
Fulwood
England
PR2 9HT
Oldchurch Hospital
Romford
England
RM7 OBE
Pembury Hospital
Tunbridge Wells
England
TN2 4QJ
Southampton General Hospital
Southampton
England
SO16 6YD
Staffordshire General Hospital
Stafford
England
ST16 3SA
Royal Marsden - Surrey
Sutton
England
SM2 5PT
Edinburgh Cancer Centre at Western General Hospital
Edinburgh
Scotland
EH4 2XU
Southern General Hospital
Glasgow
Scotland
G51 4TF
Velindre Cancer Center at Velindre Hospital
Cardiff
Wales
CF14 2TL
London
EC1A 7BE
Glan Clwyd Hospital
Rhyl
Wales
LL 18 5UJ
Cambridge
CB2 2QQ
Guy's Hospital
London
SE1 9RT
Belfast
BT9 7AB
Bio-Images Research Ltd
Glasgow
Scotland
G4 0SF
Novartis Investigative Site
Cheltenham
Gloucestershire
GL53 7AN
Novartis Investigative Site
Wolverhampton
WV10 0QP
Doncaster
DN2 5LT
Chester
CH2 1UL
Dudley
DY1 2HQ
Liverpool
L9 7AL
Reading
RG1 5AN
Salisbury
SP2 8BJ
University Hospital of Wales
Cardiff
CF14 4XN
Royal Marsden Hospital - Sutton
London
England
SW3 6JJ
Winchester
Hampshire
SO22 5DG
Leeds
West Yorkshire
LS1 3EX
Royal United Hospital
Bath
England
BA1 3NG
Saint Richards Hospital
England
P019 4SE
King George Hospital
Ilford
England
IG3 8YB
St. George's Hospital
London
England
SW17 ORE
University College Hospital - London
London
England
WC1E 6AU
Cancer Research Centre at Weston Park Hospital
England
S1O 2SJ
City Hospital - Birmingham
West Bromwich
England
B71 4HJ
Bristol
BS2 8ED
Clatterbridge Centre for Oncology NHS Trust
Birkenhead
England
CH63 4JY
Glasgow Renal and Transplant Unit
Glasgow
G11 6NT
Bradford
BD9 6RJ
Royal Bournemouth Hospital
Bournemouth
Dorset
BH7 7DW
Grimsby
DN33 2BA
Whiston Hospital
Rainhill
England
L35 5DR
Stoke Mandeville Hospital
Aylesbury
England
HP21 8AL
Oxford Radcliffe Hospital
Oxford
England
0X3 9DU
Hillingdon Hospital
Uxbridge
England
UB8 3NN
City Hospital - Birmingham
Birmingham
England
B18 7QH
Gateshead
NE9 6SX
Middlesbrough
TS4 3BW
Royal Liverpool University Hospital
Liverpool
England
L69 3GA
Freeman Hospital
Newcastle upon Tyne
England
NE7 7DN
Royal Free Hospital
London
England
NW3 2QG
Essex County Hospital
Manchester
England
C03 3NB
Taunton and Somerset Hospital
Taunton
England
TA1 5DA
Investigational Site Number 826003
Norwich
NR1 3SR
Scunthorpe General Hospital
Scunthorpe
England
DN15 7BH
Royal Gwent Hospital
Wales
NP9 2UB
University Hospital of North Staffordshire
Stoke-on-Trent
England
ST4 7LN
Hinchingbrooke Hospital
England
PE18 6NT
Torbay Hospital
Torquay
England
TQ2 7AA
Singleton Hospital
Sketty
SA 2 8QA
Portsmouth Hospitals NHS Trust
Guildford
England
P03 6AD
Kent and Canterbury Hospital
Canterbury
England
CT2 7NR
Great Western Hospital
Swindon
SN1 4JU
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
Australia, Belgium, Canada, Denmark, Egypt, France, Hungary, Italy, Netherlands, New Zealand, Norway, Poland, Portugal, Slovakia, Slovenia, South Africa, Sweden, 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
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
EudraCT Number
Not available for this trial
Funder(s)
  • Lymphoma Trials Office
  • Stichting Hemato-Oncologie voor Volwassenen Nederland
  • Australasian Leukaemia and Lymphoma Group
  • NCIC Clinical Trials Group
  • Nordic Lymphoma Group
Other Study ID Numbers
EORTC-20981
Sponsor(s)
European Organisation for Research and Treatment of Cancer - EORTC
Key Dates

Recruitment Start Date

May 1999

Recruitment End Date

Apr 2004

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

21 Jan 2000

Date updated in source

03 Feb 2016