Zevalin And Rituxan For The Treatment Of Relapsed Or Refractory Diffuse Large B-Cell Non-Hodgkin's Lymphoma
rituximab
+ cytarabine
+ liposomal cytarabine
Maladies du Système Immunitaire+6
+ Troubles immunoprolifératifs
+ Lymphome
Étude thérapeutique
Résumé
Date de début de l'étude : 1 décembre 2003
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: * Determine the best overall response in patients with relapsed or refractory diffuse large B-cell non-Hodgkin's lymphoma treated with yttrium Y 90 ibritumomab tiuxetan and rituximab. * Determine the event-free survival of patients treated with this regimen. * Determine the toxicity of this regimen in these patients. OUTLINE: This is an open-label, multicenter study. * Radioimmunotherapy: Patients receive indium In 111 ibritumomab tiuxetan IV over 10 minutes on day 1 (for imaging only); yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8; and rituximab IV over 3-4 hours on days 1, 8, 15, 22, 29, and 36. * CNS ( central nervous system)prophylaxis: Patients receive CNS prophylaxis comprising intrathecal (IT) methotrexate or IT cytarabine on days 15, 22, 29, and 36 OR IT cytarabine (liposomal) on days 15 and 29. * Maintenance rituximab: Patients are assessed for response at week 14. Beginning at month 6, patients with stable or responding disease receive maintenance therapy comprising rituximab IV over 3-4 hours once weekly for 4 weeks. Maintenance therapy repeats every 6 months for 2 years (total of 4 courses) in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years and then every 6 months for 2 years. PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 2 years.
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.25 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.De 18 à 120 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 confirmed diffuse large B-cell non-Hodgkin's lymphoma, including any of the following: * B-cell diffuse large cell variant * Immunoblastic * Mediastinal (thymic) large cell * T-cell/histiocyte-rich * Anaplastic large B-cell * Intravascular large B-cell * Lymphomatoid granulomatosis * Relapsed or refractory disease after at least 1 prior chemotherapy regimen and requires further treatment * Relapsed disease, defined as the following: * Appearance of any new lesion OR increase of at least 50% in the size of a previously involved site * 50% increase in greatest diameter of any previously identified node greater than 1 cm in the short axis OR in the sum of the perpendicular diameter (SPD) of more than 1 node * Progressive disease, defined as the following: * 50% increase from nadir in the SPD of any previously identified abnormal node * Appearance of any new lesion during or at the end of therapy * CD20-positive disease by immunohistochemistry * Bidimensionally measurable disease * At least 1 lesion at least 2.0 cm by CT scan * Less than 25% bone marrow involvement by lymphoma * No transformed lymphoma from indolent to aggressive * No HIV- or AIDS-related lymphoma * No hypocellular bone marrow * No marked reduction in bone marrow precursors of 1 or more cell lines (e.g., granulocytic, megakaryocytic, or erythroid) * No CNS lymphoma * Ineligible for myeloablative therapy OR refused transplantation * Ineligible for any other open yttrium Y 90 ibritumomab tiuxetan investigational protocols PATIENT CHARACTERISTICS: Age * 18 and over Performance status * WHO 0-2 Life expectancy * At least 3 months Hematopoietic * Absolute neutrophil count at least 1,500/mm\^3 * Lymphocyte count no greater than 5,000/mm\^3 (for patients with small lymphocytic lymphoma) * Platelet count at least 100,000/mm\^3 Hepatic * Bilirubin no greater than 2.0 mg/dL Renal * Creatinine no greater than 2.0 mg/dL Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 1 year after study participation * No concurrent serious nonmalignant disease or infection that would preclude study participation * No human antimurine antibody reactivity PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics * No prior autologous bone marrow transplantation * No prior peripheral blood stem cell rescue * No prior failed stem cell collection * Prior rituximab within the past 90 days allowed provided patient has fludeoxyglucose-avid disease that is also indium In 111 ibritumomab tiuxetan-avid disease in at least 1 lesion * More than 2 weeks since prior filgrastim (G-CSF) or sargramostim (GM-CSF) Chemotherapy * See Disease Characteristics Endocrine therapy * Not specified Radiotherapy * No prior radioimmunotherapy * No prior external beam radiotherapy (involved field or regional) to more than 25% of active bone marrow Surgery * More than 4 weeks since prior major surgery (except diagnostic surgery) Other * Recovered from all prior therapy * More than 4 weeks since prior therapy for lymphoma * More than 8 weeks since prior phase II investigational drugs * No other concurrent antineoplastic therapy
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.Un seul groupe d'intervention est désigné dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
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 2 sites
Fletcher Allen Health Care - Medical Center Campus
Burlington, United States