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Primary Rituximab and Maintenance

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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

Tracking Information
First Submitted Date  ICMJE August 22, 2005
First Posted Date  ICMJE September 1, 2005
Last Update Posted Date March 13, 2017
Actual Study Start Date  ICMJE December 2004
Actual Primary Completion Date May 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 1, 2015)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 31, 2005)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 1, 2015)
  • Response rates, event driven survival endpoints (EFS, PFS, OS) [ Time Frame: 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 31, 2005)
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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Primary Rituximab and Maintenance
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Follicular Lymphoma
Intervention  ICMJE Drug: Rituximab
rituximab 375 mg/m2 every 8 weeks for 24 months (12 injections) or control with no treatment
Study Arms  ICMJE
  • Experimental: A : rituximab maintenance
    Maintenance with rituximab for 2 years
    Intervention: Drug: Rituximab
  • No Intervention: B : no maintenance
    No further treatment
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 2, 2007)
1217
Original Enrollment  ICMJE
 (submitted: August 31, 2005)
640
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date May 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Belgium,   Brazil,   Colombia,   Denmark,   France,   Netherlands,   New Zealand,   Peru,   Spain,   Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00140582
Other Study ID Numbers  ICMJE PRIMA
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Lymphoma Study Association
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE Lymphoma Study Association
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • HOVON - Dutch Haemato-Oncology Association
  • German Low Grade Lymphoma Study Group
  • Australasian Leukaemia and Lymphoma Group
  • Institute of Cancer Research, United Kingdom
Investigators  ICMJE
Principal Investigator: Gilles A Salles, MD PhD Lymphoma Study Association
PRS Account Lymphoma Study Association
Verification Date March 2017

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