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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00112931




Registration number
NCT00112931
Ethics application status
Date submitted
2/06/2005
Date registered
3/06/2005

Titles & IDs
Public title
Rituximab in Treating Patients With Newly Diagnosed Stage II, Stage III, or Stage IV Follicular Non-Hodgkin's Lymphoma
Scientific title
An Intergroup Randomised Trial of Rituximab Versus a Watch and Wait Strategy in Patients With Advanced Stage, Asymptomatic, Non-Bulky Follicular Lymphoma
Secondary ID [1] 0 0
CRUK-2004-001621-16
Secondary ID [2] 0 0
CDR0000427312
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Active comparator: Watch and Wait - Watch and Wait - no treatment

Experimental: Arm C Rituximab 4 and Rixuximab Maintenance - 4 infusions - 375mg/m2 every 2 months. A single dose of rituximab (375mg/m2 will then be given at 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92 and 100 weeks
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time until initiation of therapy (chemotherapy or radiotherapy)
Timepoint [1] 0 0
Time from randomisation until the first day systemic chemotherapy or radiotherapy is given. If rituximab is given to patients in the watch and wait arm this will be considered as initiation of chemotherapy.
Secondary outcome [1] 0 0
Frequency of clinical spontaneous remission
Timepoint [1] 0 0
From randomisation until the initiation of chemotherapy in the watch and wait arm
Secondary outcome [2] 0 0
Cause specific survival
Timepoint [2] 0 0
Time from randomisation to death from lymphoma or immediate therapy related toxicity
Secondary outcome [3] 0 0
Overall survival
Timepoint [3] 0 0
Time from randomisation to death from any cause.
Secondary outcome [4] 0 0
Response rate at 25 months
Timepoint [4] 0 0
Response at 25 months

Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:

* Histologically confirmed follicular non-Hodgkin's lymphoma

* Diagnosed within the past 3 months
* Grade 1, 2, or 3a disease
* Stage II-IV disease
* No evidence of histological transformation
* Bidimensionally measurable disease by clinical examination or radiography
* Asymptomatic disease without B symptoms or severe pruritus
* Low tumor burden, defined by all of the following criteria:

* Lactic dehydrogenase normal
* Largest nodal or extranodal mass < 7 cm
* No more than 3 nodal sites with a diameter > 3 cm
* No clinically detectable significant serous effusion by chest x-ray

* Clinically non-evident small effusion on CT scan is not considered significant
* Spleen enlargement = 16 cm by CT scan
* Circulating tumor cells < 5,000/mm^3
* No organ compression (i.e., ureteric obstruction)

PATIENT CHARACTERISTICS:

Age

* 18 and over

Performance status

* ECOG 0-1

Life expectancy

* Not specified

Hematopoietic

* Absolute neutrophil count > 1,500/mm^3
* Platelet count > 100,000/mm^3
* Hemoglobin > 10 g/dL

Hepatic

* AST and ALT normal
* Alkaline phosphatase normal
* Bilirubin normal

Renal

* Creatinine < 2 times upper limit of normal (unless due to lymphoma)

Other

* Not pregnant or nursing
* Fertile patients must use effective contraception during and for 12 months after completion of rituximab
* No known HIV positivity
* No other malignancy within the past 2 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
* No critical organ failure
* No other immediate life-threatening disease

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* Not specified

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* Not specified

Other

* No prior therapy for lymphoma
Minimum age
18 Years
Maximum age
120 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
14/09/2023
Sample size
Target
Accrual to date
Final
462
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Queen Elizabeth Hospital - Adelaide
Recruitment hospital [2] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [3] 0 0
Ashford Cancer Centre - Black Forest
Recruitment hospital [4] 0 0
Boxhill Hospital - Box Hill
Recruitment hospital [5] 0 0
Royal Brisbane and Women's Hospital - Brisbane
Recruitment hospital [6] 0 0
Canberra Hospital - Canberra
Recruitment hospital [7] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [8] 0 0
Frankston Hospital - Frankston
Recruitment hospital [9] 0 0
Fremantle Hospital - Fremantle
Recruitment hospital [10] 0 0
Gosford Hospital - Gosford
Recruitment hospital [11] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [12] 0 0
Nepean Hospital - Kingswood
Recruitment hospital [13] 0 0
Lismore Base Hospital - Lismore
Recruitment hospital [14] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [15] 0 0
Alfred Hospital - Melbourne
Recruitment hospital [16] 0 0
Austin Health - Melbourne
Recruitment hospital [17] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [18] 0 0
St Vincent's Hospital - Melbourne
Recruitment hospital [19] 0 0
Mater Misericordiae Hospital - Newcastle
Recruitment hospital [20] 0 0
Royal Perth Hospital - Perth
Recruitment hospital [21] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [22] 0 0
St Vincent's Hospital - Sydney
Recruitment hospital [23] 0 0
Westmead Hospital - Westmead
Recruitment hospital [24] 0 0
Murray Valley Private Hospital - Wodonga
Recruitment hospital [25] 0 0
Wollongong Hospital - Wollongong
Recruitment hospital [26] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Black Forest
Recruitment postcode(s) [3] 0 0
- Box Hill
Recruitment postcode(s) [4] 0 0
- Brisbane
Recruitment postcode(s) [5] 0 0
- Canberra
Recruitment postcode(s) [6] 0 0
- Concord
Recruitment postcode(s) [7] 0 0
- Frankston
Recruitment postcode(s) [8] 0 0
- Fremantle
Recruitment postcode(s) [9] 0 0
- Gosford
Recruitment postcode(s) [10] 0 0
- Hobart
Recruitment postcode(s) [11] 0 0
- Kingswood
Recruitment postcode(s) [12] 0 0
- Lismore
Recruitment postcode(s) [13] 0 0
- Liverpool
Recruitment postcode(s) [14] 0 0
- Melbourne
Recruitment postcode(s) [15] 0 0
- Newcastle
Recruitment postcode(s) [16] 0 0
- Perth
Recruitment postcode(s) [17] 0 0
- St Leonards
Recruitment postcode(s) [18] 0 0
- Sydney
Recruitment postcode(s) [19] 0 0
- Westmead
Recruitment postcode(s) [20] 0 0
- Wodonga
Recruitment postcode(s) [21] 0 0
- Wollongong
Recruitment postcode(s) [22] 0 0
- Woolloongabba
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Christchurch
Country [3] 0 0
New Zealand
State/province [3] 0 0
Westlake
Country [4] 0 0
United Kingdom
State/province [4] 0 0
England
Country [5] 0 0
United Kingdom
State/province [5] 0 0
Scotland
Country [6] 0 0
United Kingdom
State/province [6] 0 0
Wales

Funding & Sponsors
Primary sponsor type
Other
Name
University College, London
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Cancer Research UK
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
Roche Pharma AG
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Kirit Ardeshna
Address 0 0
Mount Vernon Cancer Centre at Mount Vernon Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT00112931