The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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
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
Secondary ID [1] 0 0
PRIMA
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Follicular 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
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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS) - defined as the time from randomization to progression, relapse, death from any cause.
Timepoint [1] 0 0
number of event observed driven : 344 events or 10 years
Secondary outcome [1] 0 0
Response rates, event driven survival endpoints (EFS, PFS, OS)
Timepoint [1] 0 0
number of event observed driven : 344 events or 10 years
Secondary outcome [2] 0 0
Quality of life
Timepoint [2] 0 0
number of event observed driven : 344 events or 10 years

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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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.

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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Australian Leukemia and Lymphoma Group - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Belgium
State/province [2] 0 0
Gent
Country [3] 0 0
Belgium
State/province [3] 0 0
Mont-Godinne
Country [4] 0 0
Brazil
State/province [4] 0 0
Sao Paulo
Country [5] 0 0
Colombia
State/province [5] 0 0
Bogota
Country [6] 0 0
Denmark
State/province [6] 0 0
Herlev
Country [7] 0 0
France
State/province [7] 0 0
Bordeaux
Country [8] 0 0
France
State/province [8] 0 0
Créteil
Country [9] 0 0
France
State/province [9] 0 0
Lille
Country [10] 0 0
France
State/province [10] 0 0
Lyon
Country [11] 0 0
France
State/province [11] 0 0
Paris
Country [12] 0 0
France
State/province [12] 0 0
Pierre-Bénite cedex
Country [13] 0 0
France
State/province [13] 0 0
Reims
Country [14] 0 0
France
State/province [14] 0 0
Rouen
Country [15] 0 0
France
State/province [15] 0 0
Toulouse
Country [16] 0 0
France
State/province [16] 0 0
Villejuif
Country [17] 0 0
Netherlands
State/province [17] 0 0
Utrecht
Country [18] 0 0
New Zealand
State/province [18] 0 0
Auckland
Country [19] 0 0
Peru
State/province [19] 0 0
Lima
Country [20] 0 0
Spain
State/province [20] 0 0
Barcelona
Country [21] 0 0
Thailand
State/province [21] 0 0
Bangkok

Funding & Sponsors
Primary sponsor type
Other
Name
Lymphoma Study Association
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
HOVON - Dutch Haemato-Oncology Association
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
German Low Grade Lymphoma Study Group
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Australasian Leukaemia and Lymphoma Group
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Institute of Cancer Research, United Kingdom
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT00140582
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gilles A Salles, MD PhD
Address 0 0
Lymphoma Study Association
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

Summary results
Other publications