Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study for Newly Diagnosed Follicular Lymphoma Patients With a Large Tumor Burden

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: NCT00136552
Recruitment Status : Completed
First Posted : August 29, 2005
Last Update Posted : July 3, 2007
Sponsor:
Information provided by:
Lymphoma Study Association

Tracking Information
First Submitted Date  ICMJE August 25, 2005
First Posted Date  ICMJE August 29, 2005
Last Update Posted Date July 3, 2007
Study Start Date  ICMJE May 2000
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: August 25, 2005)
Event free survival
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 6, 2005)
  • Response rate
  • Overall survival
Original Secondary Outcome Measures  ICMJE
 (submitted: August 25, 2005)
Response rate, overall survival
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study for Newly Diagnosed Follicular Lymphoma Patients With a Large Tumor Burden
Official Title  ICMJE FL-2000 Study for Newly Diagnosed Follicular Lymphoma Patients With a High Tumor Burden
Brief Summary The purpose of this study is to assess in a prospective multicentric study (Phase III) the introduction of a monoclonal antibody directed against B-cells associated with a standard therapy including chemotherapy and alpha-interferon in first line treatment of patients with a large tumor burden follicular lymphoma.
Detailed Description

Follicular lymphoma patients with a large tumor burden will be randomized for 18 months of treatment with either:

  • Arm A: CHVP + alpha2a-interferon. Patients will receive 12 courses of CHVP (cyclophosphamide 600 mg/m², adriamycin 25 mg/m², etoposide 100 mg/m² on day 1 and prednisolone 40 mg/m² for 5 days), one course every month for 6 months then one course every other month for 12 additional months associated with alpha2a-interferon 4.5 millions units sub-cutaneously three times a week for 18 months.
  • Arm B: CHVP + alpha2a-interferon + rituximab. Patients will receive 6 monthly courses of CHVP (cyclophosphamide 600 mg/m², adriamycin 25 mg/m², etoposide 100 mg/m² on day 1 and prednisolone 40 mg/m² for 5 days) associated with 6 infusions of rituximab (375 mg/m2) associated with alpha2a-interferon 4.5 millions units sub-cutaneously three times a week for 18 months.
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 Lymphoma
Intervention  ICMJE Drug: rituximab
Study Arms  ICMJE Not Provided
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
Enrollment  ICMJE
 (submitted: August 25, 2005)
360
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE December 2004
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically confirmed follicular lymphoma with a biopsy performed in the last 3 months
  • Patients previously untreated.
  • Patients with at least one of the following symptoms requiring initiation of treatment:

    • Bulky disease at study entry according to the Groupe d'Etudes Lymphomes Folliculare (GELF) criteria: nodal or extranodal mass > 7cm in its greater diameter
    • B symptoms
    • Eastern Cooperative Oncology Group (ECOG) performance status (PS) > 1
    • Elevated serum lactate dehydrogenase (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 and less than 76 years
  • Having previously signed a written informed consent form.

Exclusion Criteria:

  • Transformation to high-grade lymphoma (secondary to "low-grade" follicular lymphoma).
  • Patients without a large tumor burden.
  • Patients with prior or concomitant malignancies except non-melanoma skin cancer or adequately treated in situ cervical cancer.
  • Poor renal function: Serum creatinine > 150 μmol/L,
  • Known HIV infection or active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
  • Patients with contra-indication to interferon, adriamycin, or rituximab.
  • 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.
  • Known sensitivity or allergy to murine products
  • Adult patient under tutelage.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (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 Belgium,   France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00136552
Other Study ID Numbers  ICMJE FL2000
PHRC
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Lymphoma Study Association
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gilles A Salles, MD PhD Lymphoma Study Association
PRS Account Lymphoma Study Association
Verification Date July 2007

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