Primary Rituximab and Maintenance

This study has been completed.
Sponsor:
Collaborators:
HOVON - Dutch Haemato-Oncology Association
German Low Grade Lymphoma Study Group
OSHO
Australasian Leukaemia and Lymphoma Group
Institute of Cancer Research, United Kingdom
Information provided by:
Lymphoma Study Association
ClinicalTrials.gov Identifier:
NCT00140582
First received: August 22, 2005
Last updated: January 27, 2009
Last verified: January 2009
  Purpose
  • 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 Intervention Phase
Follicular Lymphoma
Drug: Rituximab
Drug: rituximab
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Lymphoma Study Association:

Primary Outcome Measures:
  • Progression Free Survival (PFS) defined as the time from randomization to progression, relapse, death from any cause. [ Time Frame: number of event observed driven : 344 events ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate response rates, event driven survival endpoints (EFS, PFS, OS) and quality of life of three different chemotherapy regimens combined with rituximab, with or without maintenance with rituximab. [ Designated as safety issue: Yes ]

Enrollment: 1217
Study Start Date: December 2004
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
One infusion of rituximab (375 mg/m2) every 2 months for 2 years (12 infusions)
Drug: Rituximab
one infusion of rituximab (375 mg/m2) every 2 months for 2 years
Drug: rituximab
maintenance with rituximab for 2 years
No Intervention: B
no further treatment

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00140582

Locations
Argentina
Fundaleu Hospital
Buenos Aires, Argentina, CP C1114AAN
Australia
Australian Leukemia and Lymphoma Group
Melbourne, Australia
Belgium
Université de Gent
Gent, Belgium
Groupe d'Etude des Lymphomes de l'adulte
Mont-Godinne, Belgium
Brazil
Hospital Samaritano
Sao Paulo, Brazil
Colombia
Fundación Santafé de Bogotá
Bogota, Colombia
Denmark
Amtssygehuset i Herlev
Herlev, Denmark
France
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
Hôpital Saint Louis
Paris, France, 75010
Hématologie Adultes - Hôpital Necker
Paris, France, 75743
Institut Curie
Paris, France, 75005
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
Netherlands
HOVON
Utrecht, Netherlands
New Zealand
Australia New Zealand Leukemia Lymphoma Group
Auckland, New Zealand
Peru
Instituo Nacional de Enfermedades Neoplasicas
Lima, Peru
Spain
Hospital Clinic Barcelona
Barcelona, Spain
Thailand
King Chulalongkorn Memorial Hospital
Bangkok, Thailand
Sponsors and Collaborators
Lymphoma Study Association
HOVON - Dutch Haemato-Oncology Association
German Low Grade Lymphoma Study Group
OSHO
Australasian Leukaemia and Lymphoma Group
Institute of Cancer Research, United Kingdom
Investigators
Principal Investigator: Gilles A Salles, MD PhD Lymphoma Study Association
  More Information

Additional Information:
No publications provided by Lymphoma Study Association

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00140582     History of Changes
Other Study ID Numbers: PRIMA
Study First Received: August 22, 2005
Last Updated: January 27, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Lymphoma Study Association:
lymphoma
follicular
maintenance

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Follicular
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Rituximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 20, 2014