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

Trial Source

There is no location for this trial

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Health Conditions
  • Lymphoma
Unfortunately contact details are not available for this trial.
Primary Contact Details
Not Recruiting
Recruitment Status
NCT00004179
Primary Trial ID Number
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 as assessed by modified Lexcor criteria after induction therapy; null; Progression-free survival after maintenance therapy; null
Secondary Outcome Measures
  • Overall survival; null; Event-free survival after induction therapy; null; Time to new lymphoma treatment after maintenance therapy; null
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. Epub 2010 Apr 5.; 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. Epub 2010 May 3.; 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. Epub 2006 Jul 27.; 16873669
Result Reports
This is available on the Clinicaltrials.gov website
Gender
Both
Age Range
18 Years - N/A
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
Trial Location(s)
Addenbrooke's Hospital
Cambridge
England
CB2 2QQ
Guy's Hospital
London
England
SE1 9RT
Research Site
London
SW3 6JJ
City Hospital, Ascot Clinic
Birmingham
B18 7QH
Royal United Hospital NHS Trust
Bath
Somerset
BA1 3NG
Leeds General Infirmary
Leeds
England
LS1 3EX
Southampton General Hospital
Southampton
England
SO16 6YD
The Royal Berkshire and Battle Hospitals NHS Trust
Reading
RG1 5AN
GSK Investigational Site
Bradford
BD9 6RJ
St. Helier Hospital
Carshalton
England
SM5 1AA
Grimsby
DN33 2BA
Exeter
Devon
EX2 5DW
St. Bartholomew's and The Royal London Hospital
London
EC1A 7BE
Aintree University Hospitals NHS Foundation Trust
Liverpool
Merseyside
L9 7AL
St George's Healthcare NHS Trust
London
SW17 0QT
Novartis Investigative Site
Uxbridge
UB8 3NN
South Tees NHS Trust
Middlesbrough
Teeside
TS4 3BW
Belfast City Hospital
Belfast
BT9 7AB
Research Site
Sutton
Surrey
SM2 5PT
Clatterbridge Centre for Oncology
Merseyside
England
CH63 4JY
Leicester Royal Infirmary
Leicester
England
LE1 5WW
Glasgow Royal Infirmary
Glasgow
G4 0SF
Blackpool Victoria Hospital
Blackpool
England
FY3 8NR
GSK Investigational Site
Glasgow
G11 6NT
London
WC1E 6AU
Dept of Child Health, UHW
Cardiff
South Glamorgan
CF14 4XN
Edinburgh Cancer Centre at Western General Hospital
Edinburgh
Scotland
EH4 2XU
Birmingham Heartlands Hospital
Birmingham
England
B9 5SS
Freeman Hospital
Newcastle-Upon-Tyne
England
NE7 7DN
New Cross Hospital
Wolverhampton
Midlands
WV10 0QP
Novartis Investigative Site
Gateshead
Tyne and Wear
NE9 6SX
Cheltenham General Hospital
Cheltenham
England
GL53 7AN
Novartis Investigative Site
Cardiff
CF14 2TL
Research Site
Dudley
DY1 2HQ
The Southern Hospital, Neurology Department
Glasgow
Scotland
G51 4TF
Liverpool
L69 3GA
Royal Bournemouth General Hospital
Bournemouth
BH7 7DW
Salisbury
SP2 8BJ
Royal Preston Hospital, Lancashire Teaching Hospitals NHS Foundation Trust
Preston
PR2 9HT
Saint Richards Hospital
Chichester
England
P019 4SE
King George Hospital
Ilford, Essex
England
IG3 8YB
Scunthorpe General Hospital
Scunthorpe
England
DN15 7BH
Staffordshire General Hospital
Stafford
England
ST16 3SA
Kettering General Hosptial
Kettering, Northants
England
NNI6 8UZ
Hull Royal Infirmary
Hull
HU3 2KZ
Great Western Hospital
Swindon,
SN1 4JU
Research Site
Northwood
Middlesex
HA6 2RN
Weston Park Hospital
Sheffield
England
S1O 2SJ
St George's Hospital Medical School
London
Sw17 ORE
Oxford Radcliffe Hospital
Oxford
England
0X3 9DU
Royal Gwent Hospital
Newport Gwent
Wales
NP9 2UB
Taunton and Somerset Hospital
Taunton Somerset
England
TA1 5DA
Glan Clwyd Hospital
Rhyl, Denbighshire
Wales
LL 18 5UJ
Singleton Hospital
Swansea
England
SA 2 8QA
Bristol Haematology & Oncology Centre
Bristol
BS2 8ED
Oldchurch Hospital
Romford
England
RM7 OBE
Countess of Chester Hospital
Chester
England
CH2 1UL
Royal Hampshire County Hospital
Winchester
England
SO22 5DG
Norfolk & Norwich Hospital
Norwich
England
NR1 3SR
North Staffs Royal Infirmary
Stoke-On-Trent
England
ST4 7LN
Sandwell Hospital
West Bromwich
B71 4HJ
Pfizer Investigational Site
Doncaster
South Yorkshire
DN2 5LT
Torbay Hospital
Torquay Devon
England
TQ2 7AA
Whiston Hospital
Prescot Merseyside
England
L35 5DR
Colchester
C03 3NB
UCL Cancer Institute
Hampstead, London
England
NW3 2QG
Portsmouth Hospitals NHS Trust
Portsmouth
England
P03 6AD
Stoke Mandeville Hospital
Aylesbury-Buckinghamshire
England
HP21 8AL
Kent and Canterbury Hospital
Canterbury
England
CT2 7NR
Pembury Hospital
Royal Tunbridge Wells, Kent
England
TN2 4QJ
Hinchingbrooke Hospital
Huntingdon
England
PE18 6NT
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
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 Assigned

21 Jan 2000

Last Updated

10 Feb 2015