Randomized Phase III Trial Comparing Two Different Rituximab Dosing Regimens For Patients With Low Tumor Burden Indolent Non-Hodgkin's Lymphoma
rituximab
Maladies du Système Immunitaire+5
+ Troubles immunoprolifératifs
+ Lymphome
Étude thérapeutique
Résumé
Date de début de l'étude : 23 janvier 2004
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: Primary * To compare time to rituximab failure between the rituximab scheduled and rituximab retreatment arms. Secondary * To compare the time to first cytotoxic therapy between the rituximab scheduled and rituximab retreatment arms. * To document the rationale for beginning cytotoxic therapy; defined as chemotherapy, radiation therapy or radioimmunotherapy. * To compare the toxicities associated with rituximab therapy between the two randomized treatment arms. * Quality of Life Objectives: 1. To compare health-related quality of life, distress, psychological functioning, physical well-being and functional well-being of patients receiving rituximab scheduled to those receiving rituximab retreatment. 2. To examine the impact of differential treatment response (delayed time to rituximab failure and/or time to first cytotoxic therapy), if observed, on quality of life, distress, and psychological functioning on patients receiving rituximab scheduled to those receiving rituximab retreatment. 3. To obtain prospective data on physical and functional well-being during treatment with rituximab. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to histologic subtype (follicular vs other), age (under 60 vs 60 and over), and the time from diagnosis (less than 1 year vs at least 1 year). * Induction rituximab: Patients receive rituximab Intravenous (IV) once a week for 4 weeks. Patients are re-evaluated 9 weeks after the completion of induction rituximab. Patients with a partial or complete response to induction rituximab are randomized to 1 of 2 treatment arms. * Arm A (retreatment rituximab): Patients receive rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months. * Arm B (scheduled rituximab): Patients receive a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity. Quality of life is assessed after induction rituximab treatment and at 26, 39, 65, 117, 169, and 221 weeks after randomization. Patients are followed at least annually for 15 years from study entry.
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.545 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
INCLUSION CRITERIA: * Histologically confirmed non-Hodgkin's lymphoma, including 1 of the following: * Follicular grade 1 or 2 * Small lymphocytic * Marginal zone (nodal) * Marginal zone (splenic) * Mucosa-associated lymphoid tissue (MALT) * Stage III or IV disease * Must meet the following criteria for low tumor burden: * No nodal or extranodal mass at least 7 cm * Less than 3 nodal masses greater than 3 cm in diameter * No systemic symptoms or B symptoms * No splenomegaly greater than 16 cm by a computed tomography (CT) scan * No evidence of risk of compression of a vital organ (i.e., ureteral or epidural) * No leukemic phase with greater than 5,000/mm\^3 circulating lymphocytes * No cytopenias, defined as any of the following: * Platelet count less than 100,000/mm\^3 * Hemoglobin less than 10 g/dL * Absolute neutrophil count less than 1,500/mm\^3 * At least 1 objective measurable disease parameter * Abnormal positron emission tomography (PET) scans will not constitute evaluable disease unless verified by CT scan or other appropriate imaging * Age: 18 and over * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Must meet the following criteria for labs: * Hematopoietic * Absolute neutrophil count at least 1,500/mm\^3\* * Hemoglobin at least 10 g/dL\* * Platelet count at least 100,000/mm\^3\* * NOTE: \*Without growth factor and/or transfusion support * Hepatic * Bilirubin no greater than 2 times upper limit of normal (ULN) OR direct bilirubin normal for patients with Gilbert's Syndrome * The aspartate transaminase (AST) and alanine transaminase (ALT) ratio (AST/ALT) no greater than 5 times ULN * Hepatitis B surface antigen negative * Renal * Creatinine no greater than 2 times ULN EXCLUSION CRITERIA: * Evidence of transformation to a large cell histology * Pregnant or nursing. Fertile patients must use effective contraception * HIV positive * Uncontrolled active infection * Other malignancy within the past 2 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix * Prior immunotherapy for lymphoma * Prior chemotherapy for lymphoma * Concurrent chemotherapy * Prior radiotherapy for lymphoma * Concurrent radiotherapy * Concurrent radioimmunotherapy
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
Comparateur actifGroupe II
ExpérimentalObjectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres 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 480 sites
Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
Fort Smith, United StatesArkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, United StatesProvidence Saint Joseph Medical Center - Burbank
Burbank, United States