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Follicular LymphomaPhase 3NCT00140582

Primary Rituximab and Maintenance

A Phase 3 study testing Rituximab in people with Follicular Lymphoma, run by Lymphoma Study Association at 24 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Follicular Lymphoma
What is being tested?
Rituximab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,217 participants
Where
24 sitesin 12 countries
Study dates
Dec 2004to Dec 2016
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 18Show fewer
  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

24 sites in 12 countries.

24 sites in 12 countries

France12 sites

  • Polyclinique Bordeaux Nord

    Bordeaux, 33300

  • Hôpital Henri Mondor

    Créteil, 94010

  • Hématologie CHU de Lille

    Lille, 59000

  • Centre Léon Bérard

    Lyon, 69008

  • Institut Curie

    Paris, 75005

  • Hôpital Saint Louis

    Paris, 75010

  • Hématologie Adultes - Hôpital Necker

    Paris, 75743

  • Service d'Hématologie - Centre Hospitalier Lyon-Sud

    Pierre-Bénite, 69495

  • Centre Hospitalier Robert Debré

    Reims, 51092

  • Centre Henri Becquerel

    Rouen, 76038

  • Hématologie CHU Purpan

    Toulouse, 31059

  • Institut Gustave Roussy

    Villejuif

Other trials in France

Belgium2 sites

  • Université de Gent

    Ghent

  • Groupe d'Etude des Lymphomes de l'adulte

    Mont-Godinne

Other trials in Belgium

Argentina1 site

  • Fundaleu Hospital

    Buenos Aires, CP C1114AAN

Other trials in Argentina

Australia1 site

  • Australian Leukemia and Lymphoma Group

    Melbourne

Other trials in Australia

Brazil1 site

  • Hospital Samaritano

    São Paulo

Other trials in Brazil

Colombia1 site

  • Fundación Santafé de Bogotá

    Bogotá

Other trials in Colombia

Denmark1 site

  • Amtssygehuset i Herlev

    Herlev

Other trials in Denmark

Netherlands1 site

  • HOVON

    Utrecht

Other trials in Netherlands

New Zealand1 site

  • Australia New Zealand Leukemia Lymphoma Group

    Auckland

Other trials in New Zealand

Peru1 site

  • Instituo Nacional de Enfermedades Neoplasicas

    Lima

Other trials in Peru

Spain1 site

  • Hospital Clinic Barcelona

    Barcelona

Other trials in Spain

Thailand1 site

  • King Chulalongkorn Memorial Hospital

    Bangkok

Other trials in Thailand

About this study

Official 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

  • 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.
Read the detailed description

Study medication

  • First period: Induction of response with 8 x rituximab combined with 8 cycles of CVP or 6 cycles of CHOP in 21-day cycles or 6 cycles of FCM in 28-day cycles or 6 cycles of MCP in 28-day cycles.
  • Second period: rituximab 375 mg/m2 every 8 weeks for 24 months (12 injections) or control with no treatment
Being tested
Rituximab
Keywords
lymphoma, follicular, maintenance
Medical subject headings
Lymphoma, Follicular, Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RituximabDrug

    rituximab 375 mg/m2 every 8 weeks for 24 months (12 injections) or control with no treatment

Study groups in NCT00140582
Study groupRoleWhat they receive
A : rituximab maintenanceExperimentalMaintenance with rituximab for 2 years
Receives: Drug: Rituximab
B : no maintenanceNo interventionNo further treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival (PFS)

    defined as the time from randomization to progression, relapse, death from any cause.

    Measured: number of event observed driven : 344 events or 10 years

Secondary outcomes (2)

  1. Response rates, event driven survival endpoints (EFS, PFS, OS)

    Measured: number of event observed driven : 344 events or 10 years

  2. Quality of life

    Measured: number of event observed driven : 344 events or 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Sep 2005 (estimated)
  2. Study startDec 2004
  3. Primary completionMay 2007
  4. Study completionDec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,217 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00140582
Sponsor's protocol ID
PRIMA
Status last verified
Mar 2017
First submitted
22 Aug 2005
Last updated
13 Mar 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Bachy E, Seymour JF, Feugier P, Offner F, Lopez-Guillermo A, Belada D, Xerri L, Catalano JV, Brice P, Lemonnier F, Martin A, Casasnovas O, Pedersen LM, Dorvaux V, Simpson D, Leppa S, Gabarre J, da Silva MG, Glaisner S, Ysebaert L, Vekhoff A, Intragumtornchai T, Le Gouill S, Lister A, Estell JA, Milone G, Sonet A, Farhi J, Zeuner H, Tilly H, Salles G. Sustained Progression-Free Survival Benefit of Rituximab Maintenance in Patients With Follicular Lymphoma: Long-Term Results of the PRIMA Study. J Clin Oncol. 2019 Nov 1;37(31):2815-2824. doi: 10.1200/JCO.19.01073. Epub 2019 Jul 24.

    PubMed 31339826

  • Zhou X, Wang J, Zhang J, Copley-Merriman C, Torigoe Y, Reyes C, Seymour JF, Offner FC, Trneny M, Salles GA. Symptoms and toxicity of rituximab maintenance relative to observation following immunochemotherapy in patients with follicular lymphoma. Hematology. 2015 Apr;20(3):129-36. doi: 10.1179/1607845414Y.0000000179. Epub 2014 Jul 16.

    PubMed 25029908

  • Ghesquieres H, Cartron G, Seymour JF, Delfau-Larue MH, Offner F, Soubeyran P, Perrot A, Brice P, Bouabdallah R, Sonet A, Dupuis J, Casasnovas O, Catalano JV, Delmer A, Jardin F, Verney A, Dartigues P, Salles G. Clinical outcome of patients with follicular lymphoma receiving chemoimmunotherapy in the PRIMA study is not affected by FCGR3A and FCGR2A polymorphisms. Blood. 2012 Sep 27;120(13):2650-7. doi: 10.1182/blood-2012-05-431825. Epub 2012 Aug 10.

    PubMed 22885164

  • Salles G, Seymour JF, Offner F, Lopez-Guillermo A, Belada D, Xerri L, Feugier P, Bouabdallah R, Catalano JV, Brice P, Caballero D, Haioun C, Pedersen LM, Delmer A, Simpson D, Leppa S, Soubeyran P, Hagenbeek A, Casasnovas O, Intragumtornchai T, Ferme C, da Silva MG, Sebban C, Lister A, Estell JA, Milone G, Sonet A, Mendila M, Coiffier B, Tilly H. Rituximab maintenance for 2 years in patients with high tumour burden follicular lymphoma responding to rituximab plus chemotherapy (PRIMA): a phase 3, randomised controlled trial. Lancet. 2011 Jan 1;377(9759):42-51. doi: 10.1016/S0140-6736(10)62175-7. Epub 2010 Dec 20.

    PubMed 21176949

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rituximab in people with Follicular Lymphoma, run by Lymphoma Study Association at 24 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in France, Belgium, Argentina, Australia, Brazil and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) (time frame: number of event observed driven : 344 events or 10 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00140582, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2017.

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