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

August 22, 2005
January 27, 2009
December 2004
May 2007   (final data collection date for primary outcome measure)
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 ]
Event Free Survival (EFS) defined as the time from randomization to progression, relapse, death from any cause, or requirement of a new treatment whatever the reason.
Complete list of historical versions of study NCT00140582 on ClinicalTrials.gov Archive Site
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 ]
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.
Not Provided
Not Provided
 
Primary Rituximab and Maintenance
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 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
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Follicular Lymphoma
  • Drug: Rituximab
    one infusion of rituximab (375 mg/m2) every 2 months for 2 years
  • Drug: rituximab
    maintenance with rituximab for 2 years
  • Experimental: A
    One infusion of rituximab (375 mg/m2) every 2 months for 2 years (12 infusions)
    Interventions:
    • Drug: Rituximab
    • Drug: rituximab
  • No Intervention: B
    no further treatment

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1217
Not Provided
May 2007   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Australia,   Belgium,   Brazil,   Colombia,   Denmark,   France,   Netherlands,   New Zealand,   Peru,   Spain,   Thailand
 
NCT00140582
PRIMA
Yes
Not Provided
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
Principal Investigator: Gilles A Salles, MD PhD Lymphoma Study Association
Lymphoma Study Association
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP