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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.
 
ClinicalTrials.gov Identifier: NCT00140582
Recruitment Status : Completed
First Posted : September 1, 2005
Last Update Posted : March 13, 2017
Sponsor:
Collaborators:
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

Study Description
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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
Study Design
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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

Arms and Interventions
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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


Outcome Measures
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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 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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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 ClinicalTrials.gov identifier (NCT number): NCT00140582


Locations
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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
Investigators
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Principal Investigator: Gilles A Salles, MD PhD Lymphoma Study Association
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Lymphoma Study Association
ClinicalTrials.gov Identifier: NCT00140582    
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:
lymphoma
follicular
maintenance
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Follicular
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
 Lymphoma, Non-Hodgkin
Rituximab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents