Randomized Trial of CHOP Chemotherapy With or Without Rituximab (Chimeric Anti-CD20 Antibody) for HIV-Associated Non-Hodgkin's Lymphoma
filgrastim
+ rituximab
+ CHOP regimen
Lymphome de Burkitt+14
+ Infections par virus ADN
+ Maladies hématologiques et lymphatiques
Étude thérapeutique
Résumé
Date de début de l'étude : 1 janvier 1999
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: I. Compare the efficacy of CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) with or without rituximab in patients with previously untreated HIV-associated non-Hodgkin's lymphoma. II. Determine the efficacy of rituximab as maintenance therapy following remission induction with CHOP in these patients. III. Determine the effect of rituximab on the immune system and HIV viral load in these patients. IV. Determine the relationship between EBV load and the presence of EBV in lymphoma tumor cells of these patients. V. Compare the effect of CHOP with or without rituximab on EBV load in these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified by extent of disease (stage I/II vs III/IV). Patients are randomized to 1 of 2 treatment arms: Arm I: Patients receive cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 3 and oral prednisone on days 3-7. Patients receive rituximab on day 1. Treatment repeats every 3 weeks for a minimum of 4 courses or 2 courses beyond complete response in the absence of disease progression or unacceptable toxicity. Patients with stage I, stage IE (including bulky), or nonbulky stage II or IIE disease receive 3 courses of chemotherapy with rituximab followed by radiotherapy beginning 3 weeks after completion of the third course. Patients who achieve partial response for a minimum of 28 days or complete response receive maintenance rituximab IV beginning on day 28 of the final course of chemotherapy. Maintenance rituximab treatment repeats every 4 weeks for 3 courses. Arm II: Patients receive cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1 and oral prednisone on days 1-5. Treatment repeats every 3 weeks for a minimum of 4 courses or 2 courses beyond complete response. Patients with stage I, stage IE (including bulky), or nonbulky stage II or IIE disease receive 3 courses of chemotherapy. Patients receive radiotherapy beginning 3 weeks after completion of the third course of chemotherapy. Both arms: Patients receive filgrastim (G-CSF) subcutaneously beginning on day 4 and continuing through day 13 of each chemotherapy course or until blood counts recover. Patients are followed every 4 weeks for 1 year and then every 2 months until death.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.120 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.À partir de 18 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
DISEASE CHARACTERISTICS: * Histologically or cytologically proven HIV-associated B cell non-Hodgkin's lymphoma, including: * Diffuse large B cell lymphoma * Intermediate grade diffuse large cell lymphoma * High grade large cell immunoblastic lymphoma * Burkitt's lymphoma * High grade B cell lymphoma, Burkitt's like (small noncleaved lymphoma) * No primary CNS lymphoma (parenchymal brain or spinal cord tumor) * Evaluable disease HIV documentation may be serologic (ELISA or western blot), culture, or quantitative PCR or bDNA assay Tumors must be CD20 positive (greater than 50% cells express CD20) * A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. PATIENT CHARACTERISTICS: * Age: Over 18 * Performance status: Karnofsky 70-100% * Absolute neutrophil count greater than 1,000/mm3\* * Platelet count greater than 75,000/mm3\* \* Unless cytopenias are secondary to lymphoma * Bilirubin less than 2.0 mg/dL (unless secondary to hepatic infiltration with lymphoma or isolated hyperbilirubinemia associated with the use of indinavir) * SGOT or SGPT less than 7 times upper limit of normal * Creatinine less than 2.0 mg/dL (unless due to lymphoma) * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No acute, active HIV-associated opportunistic infection requiring antibiotics * Mycobacterium avium complex allowed * No concurrent malignancy except carcinoma in situ of the cervix, nonmetastatic nonmelanomatous skin cancer, or Kaposi's sarcoma not requiring systemic chemotherapy PRIOR CONCURRENT THERAPY: * Prior or concurrent epoetin alfa or filgrastim (G-CSF) allowed * No prior colony stimulating factor therapy within 24 hours prior to chemotherapy * No prior chemotherapy for HIV-associated non-Hodgkin's lymphoma * At least 1 year since prior cyclophosphamide or doxorubicin * No prior radiotherapy for HIV-associated non-Hodgkin's lymphoma * Chronic therapy with myelosuppressive agents allowed * Concurrent antiretroviral therapy, antifungal medications, and antibiotics allowed
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.2 groupes d'intervention sont désignés dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
ExpérimentalGroupe II
Comparateur actifCentres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 13 sites
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, United StatesOuvrir USC/Norris Comprehensive Cancer Center and Hospital dans Google MapsJonsson Comprehensive Cancer Center, UCLA
Los Angeles, United StatesSan Francisco General Hospital Medical Center
San Francisco, United StatesSylvester Cancer Center, University of Miami
Miami, United States