Study for Newly Diagnosed Follicular Lymphoma Patients With a Large Tumor Burden
NCT ID: NCT00136552
Last Updated: 2007-07-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
360 participants
INTERVENTIONAL
2000-05-31
2004-12-31
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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rituximab
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Lymphoma Study Association
OTHER
Principal Investigators
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Gilles A Salles, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Lymphoma Study Association
Locations
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Groupe d'Etude des Lymphomes de l'adulte
Mont-Godinne, , Belgium
Hôpital Henri Mondor
Créteil, , France
Hôpital Saint Louis
Paris, , France
Service d'Hématologie - Centre Hospitalier Lyon-Sud
Pierre-Bénite, , France
Centre Henri Becquerel
Rouen, , France
Countries
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References
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Solal-Celigny P, Lepage E, Brousse N, Reyes F, Haioun C, Leporrier M, Peuchmaur M, Bosly A, Parlier Y, Brice P, et al. Recombinant interferon alfa-2b combined with a regimen containing doxorubicin in patients with advanced follicular lymphoma. Groupe d'Etude des Lymphomes de l'Adulte. N Engl J Med. 1993 Nov 25;329(22):1608-14. doi: 10.1056/NEJM199311253292203.
McLaughlin P, Grillo-Lopez AJ, Link BK, Levy R, Czuczman MS, Williams ME, Heyman MR, Bence-Bruckler I, White CA, Cabanillas F, Jain V, Ho AD, Lister J, Wey K, Shen D, Dallaire BK. Rituximab chimeric anti-CD20 monoclonal antibody therapy for relapsed indolent lymphoma: half of patients respond to a four-dose treatment program. J Clin Oncol. 1998 Aug;16(8):2825-33. doi: 10.1200/JCO.1998.16.8.2825.
Salles G, Mounier N, de Guibert S, Morschhauser F, Doyen C, Rossi JF, Haioun C, Brice P, Mahe B, Bouabdallah R, Audhuy B, Ferme C, Dartigeas C, Feugier P, Sebban C, Xerri L, Foussard C. Rituximab combined with chemotherapy and interferon in follicular lymphoma patients: results of the GELA-GOELAMS FL2000 study. Blood. 2008 Dec 15;112(13):4824-31. doi: 10.1182/blood-2008-04-153189. Epub 2008 Sep 17.
Related Links
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Official site of the Groupe d'Etudes des Lymphomes de l'Adulte (In french)
Other Identifiers
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PHRC
Identifier Type: -
Identifier Source: secondary_id
FL2000
Identifier Type: -
Identifier Source: org_study_id