Primary Rituximab and Maintenance

March 9, 2017 updated by: Lymphoma Study Association

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.

Study Overview

Status

Completed

Conditions

Intervention / 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

Study Type

Interventional

Enrollment (Actual)

1217

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, CP C1114AAN
        • Fundaleu Hospital
  • Australia
      • Melbourne, Australia
        • Australian leukemia and lymphoma group
  • Belgium
      • Gent, Belgium
        • Université de Gent
      • Mont-Godinne, Belgium
        • Groupe d'Etude des Lymphomes de l'Adulte
  • Brazil
      • Sao Paulo, Brazil
        • Hospital Samaritano
  • Colombia
      • Bogota, Colombia
        • Fundación Santafé de Bogotá
  • Denmark
      • Herlev, Denmark
        • Amtssygehuset i Herlev
  • France
      • Bordeaux, France, 33300
        • Polyclinique Bordeaux Nord
      • Créteil, France, 94010
        • Hopital Henri Mondor
      • Lille, France, 59000
        • Hématologie CHU de Lille
      • Lyon, France, 69008
        • Centre Léon Bérard
      • Paris, France, 75010
        • Hopital Saint Louis
      • Paris, France, 75005
        • Institut Curie
      • Paris, France, 75743
        • Hématologie Adultes - Hôpital Necker
      • Pierre-Bénite cedex, France, 69495
        • Service d'Hématologie - Centre Hospitalier Lyon-Sud
      • Reims, France, 51092
        • Centre Hospitalier Robert Debre
      • Rouen, France, 76038
        • Centre Henri Becquerel
      • Toulouse, France, 31059
        • Hématologie CHU Purpan
      • Villejuif, France
        • Institut Gustave Roussy
  • Netherlands
      • Utrecht, Netherlands
        • HOVON
  • New Zealand
      • Auckland, New Zealand
        • Australia New Zealand Leukemia Lymphoma Group
  • Peru
      • Lima, Peru
        • Instituo Nacional de enfermedades Neoplásicas
  • Spain
      • Barcelona, Spain
        • Hospital Clinic Barcelona
  • Thailand
      • Bangkok, Thailand
        • King Chulalongkorn Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
number of event observed driven : 344 events or 10 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Response rates, event driven survival endpoints (EFS, PFS, OS)
Time Frame: number of event observed driven : 344 events or 10 years
number of event observed driven : 344 events or 10 years
Quality of life
Time Frame: number of event observed driven : 344 events or 10 years
number of event observed driven : 344 events or 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lymphoma Study Association

Collaborators

Institute of Cancer Research, United Kingdom
Australasian Leukaemia and Lymphoma Group
HOVON - Dutch Haemato-Oncology Association
German Low Grade Lymphoma Study Group

Investigators

  • Principal Investigator: Gilles A Salles, MD PhD, Lymphoma Study Association

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2004

Primary Completion (Actual)

May 1, 2007

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

August 22, 2005

First Submitted That Met QC Criteria

August 31, 2005

First Posted (Estimate)

September 1, 2005

Study Record Updates

Last Update Posted (Actual)

March 13, 2017

Last Update Submitted That Met QC Criteria

March 9, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRIMA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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