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Primary Rituximab and Maintenance

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 evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00140582
Recruitment Status : Completed
First Posted : September 1, 2005
Last Update Posted : March 13, 2017
HOVON - Dutch Haemato-Oncology Association
German Low Grade Lymphoma Study Group
Australasian Leukaemia and Lymphoma Group
Institute of Cancer Research, United Kingdom
Information provided by (Responsible Party):
Lymphoma Study Association

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.

Condition or disease Intervention/treatment Phase
Follicular Lymphoma Drug: Rituximab Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1217 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 2004
Actual Primary Completion Date : May 2007
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab

Arm Intervention/treatment
Experimental: A : rituximab maintenance
Maintenance with rituximab for 2 years
Drug: Rituximab
rituximab 375 mg/m2 every 8 weeks for 24 months (12 injections) or control with no treatment

No Intervention: B : no maintenance
No further treatment

Primary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: number of event observed driven : 344 events or 10 years ]
    defined as the time from randomization to progression, relapse, death from any cause.

Secondary Outcome Measures :
  1. Response rates, event driven survival endpoints (EFS, PFS, OS) [ Time Frame: number of event observed driven : 344 events or 10 years ]
  2. Quality of life [ Time Frame: number of event observed driven : 344 events or 10 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00140582

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Fundaleu Hospital
Buenos Aires, Argentina, CP C1114AAN
Australian Leukemia and Lymphoma Group
Melbourne, Australia
Université de Gent
Gent, Belgium
Groupe d'Etude des Lymphomes de l'adulte
Mont-Godinne, Belgium
Hospital Samaritano
Sao Paulo, Brazil
Fundación Santafé de Bogotá
Bogota, Colombia
Amtssygehuset i Herlev
Herlev, Denmark
Polyclinique Bordeaux Nord
Bordeaux, France, 33300
Hôpital Henri Mondor
Créteil, France, 94010
Hématologie CHU de Lille
Lille, France, 59000
Centre Léon Bérard
Lyon, France, 69008
Institut Curie
Paris, France, 75005
Hôpital Saint Louis
Paris, France, 75010
Hématologie Adultes - Hôpital Necker
Paris, France, 75743
Service d'Hématologie - Centre Hospitalier Lyon-Sud
Pierre-Bénite cedex, France, 69495
Centre Hospitalier Robert Debré
Reims, France, 51092
Centre Henri Becquerel
Rouen, France, 76038
Hématologie CHU Purpan
Toulouse, France, 31059
Institut Gustave Roussy
Villejuif, France
Utrecht, Netherlands
New Zealand
Australia New Zealand Leukemia Lymphoma Group
Auckland, New Zealand
Instituo Nacional de Enfermedades Neoplasicas
Lima, Peru
Hospital Clinic Barcelona
Barcelona, Spain
King Chulalongkorn Memorial Hospital
Bangkok, Thailand
Sponsors and Collaborators
Lymphoma Study Association
HOVON - Dutch Haemato-Oncology Association
German Low Grade Lymphoma Study Group
Australasian Leukaemia and Lymphoma Group
Institute of Cancer Research, United Kingdom
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Principal Investigator: Gilles A Salles, MD PhD Lymphoma Study Association

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):

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Responsible Party: Lymphoma Study Association Identifier: NCT00140582     History of Changes
Other Study ID Numbers: PRIMA
First Posted: September 1, 2005    Key Record Dates
Last Update Posted: March 13, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Lymphoma Study Association:
Additional relevant MeSH terms:
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Lymphoma, Follicular
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents