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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00140582
Registration number
NCT00140582
Ethics application status
Date submitted
22/08/2005
Date registered
1/09/2005
Date last updated
13/03/2017
Titles & IDs
Public title
Primary Rituximab and Maintenance
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Scientific title
Advanced Follicular Lymphoma Evaluating the Benefit of Maintenance Therapy With Rituximab (MabThera®) After Induction of Response With Chemotherapy Plus Rituximab in Comparison With no Maintenance Therapy
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Secondary ID [1]
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PRIMA
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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:
Follicular Lymphoma
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Condition category
Condition code
Cancer
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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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
Treatment: Drugs - Rituximab
Experimental: A : rituximab maintenance - Maintenance with rituximab for 2 years
No Intervention: B : no maintenance - No further treatment
Treatment: Drugs: Rituximab
rituximab 375 mg/m2 every 8 weeks for 24 months (12 injections) or control with no treatment
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Intervention code [1]
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Treatment: Drugs
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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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Progression Free Survival (PFS)
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Assessment method [1]
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defined as the time from randomization to progression, relapse, death from any cause.
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Timepoint [1]
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number of event observed driven : 344 events or 10 years
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Secondary outcome [1]
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Response rates, event driven survival endpoints (EFS, PFS, OS)
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Assessment method [1]
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Timepoint [1]
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number of event observed driven : 344 events or 10 years
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Secondary outcome [2]
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Quality of life
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Assessment method [2]
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Timepoint [2]
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number of event observed driven : 344 events or 10 years
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Eligibility
Key inclusion criteria
- Histologically confirmed follicular lymphoma grade 1, 2 or 3a.
- Patients previously untreated.
- Patients with at least one of the following symptoms requiring initiation of
treatment:
- Bulky disease at study entry according to the GELF criteria: nodal or extranodal
mass > 7cm in its greater diameter
- B symptoms
- Elevated serum LDH or beta2-microglobulin
- involvement of at least 3 nodal sites (each with a diameter greater than 3 cm)
- symptomatic splenic enlargement
- compressive syndrome
- pleural/peritoneal effusion
- Age must be > 18 years.
- Performance status < 2 on the ECOG scale (see appendix E).
- Adequate hematological function within 28 days prior to registration (unless those
abnormalities are related to lymphoma extension), this includes:
- Hemoglobin = 8.0 g/dl (5.0 mmol/L)
- Absolute neutrophil count (ANC) = 1.5 109/L
- Platelet count = 100 109/L
- Women are not breast feeding, are using effective contraception, are not pregnant and
agree not to become pregnant during participation in the trial and during the 12
months thereafter. Men agree not to father a child during participation in the trial
and during the 12 months thereafter.
- Having previously signed a written informed consent form.
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Minimum age
18
Years
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Maximum age
No limit
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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
- Transformation to high-grade lymphoma (secondary to "low-grade" follicular lymphoma).
- Grade 3b follicular lymphoma.
- Presence or history of CNS disease (either CNS lymphoma or lymphomatous meningitis).
- Patients regularly taking corticosteroids during the last 4 weeks, unless administered
at a dose equivalent to < 20 mg/day prednisone.
- Patients with prior or concomitant malignancies except non-melanoma skin cancer or
adequately treated in situ cervical cancer.
- Major surgery (excluding lymph node biopsy) within 28 days prior to registration.
- Poor renal function: Serum creatinine > 2.0 mg/dl (197 µmol/L),
- Poor hepatic function: total bilirubin > 2.0 mg/dl (34 µmol/L), AST (SGOT) > 3 x the
upper limit of normal unless these abnormalities are related to lymphoma.
- Known HIV infection or active HBV or HCV infection.
- Serious underlying medical conditions, which could impair the ability of the patient
to participate in the trial (e.g. ongoing infection, uncontrolled diabetes mellitus,
gastric ulcers, active autoimmune disease). Judgment is up to the investigator.
- Life expectancy < 6 months
- Known sensitivity or allergy to murine products
- Treatment within a clinical trial within 30 days prior to trial entry
- Adult patient under tutelage.
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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
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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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
1/12/2004
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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
1/12/2016
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Sample size
Target
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Accrual to date
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Final
1217
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Australian Leukemia and Lymphoma Group - Melbourne
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Recruitment postcode(s) [1]
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- Melbourne
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Recruitment outside Australia
Country [1]
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Argentina
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State/province [1]
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Buenos Aires
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Belgium
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State/province [2]
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Gent
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Belgium
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Mont-Godinne
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Brazil
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Sao Paulo
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Colombia
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Bogota
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Denmark
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Herlev
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France
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Bordeaux
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France
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Créteil
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France
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Lille
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France
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State/province [10]
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Lyon
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France
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Paris
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France
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Pierre-Bénite cedex
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France
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Reims
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France
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Rouen
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France
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Toulouse
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France
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Villejuif
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Netherlands
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Utrecht
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New Zealand
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Auckland
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Peru
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Lima
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Spain
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Barcelona
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Thailand
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State/province [21]
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Bangkok
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Funding & Sponsors
Primary sponsor type
Other
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Name
Lymphoma Study Association
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Address
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Other collaborator category [1]
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Other
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Name [1]
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HOVON - Dutch Haemato-Oncology Association
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Address [1]
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Other collaborator category [2]
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Other
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Name [2]
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German Low Grade Lymphoma Study Group
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Address [2]
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Other collaborator category [3]
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Other
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Name [3]
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Australasian Leukaemia and Lymphoma Group
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Address [3]
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Other collaborator category [4]
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Other
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Name [4]
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Institute of Cancer Research, United Kingdom
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Address [4]
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Ethics approval
Ethics application status
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Summary
Brief summary
- Objectives
- Primary objective: To evaluate in patients with advanced follicular lymphoma the
benefit of maintenance therapy with rituximab after induction of response with
chemotherapy plus rituximab in comparison with no maintenance therapy
- Secondary objective: To evaluate response rates, event driven survival endpoints
(EFS, PFS, OS) and quality of life of four different chemotherapy regimens combined
with rituximab, with or without maintenance with rituximab, for first line
treatment of advanced stage follicular lymphoma.
- Study Design This is an international open-label, multicentre, randomized study with two
treatment phases. In the induction phase patients have to respond to 1st line induction
treatment in order to be eligible for randomization to the second phase of maintenance
treatment or observation. After the maintenance period patients will be included in the
follow up phase for 3 years.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00140582
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Gilles A Salles, MD PhD
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Address
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Lymphoma Study Association
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Fax
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Email
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Contact person for public queries
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Fax
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00140582
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