Clinical Trials Detalhe
Study Comparing Inotuzumab Ozogamicin In Combination With Rituximab Versus Defined Investigator's Choice In Follicular Non-Hodgkin's Lymphoma (NHL)
Visão Geral
Gender
ALL
Idade
N/A
Fase
PHASE3
Tipo de Estudo
INTERVENTIONAL
Localização
Hospitais Da Universidade De Coimbra (Coimbra, Portugal)
Clinicaltrial.gov
https://classic.clinicaltrials.gov/ct2/show/NCT00562965Sumário
This protocol is designed to assess the efficacy and safety of inotuzumab ozogamicin given with rituximab compared to a defined investigator's choice therapy. Subjects will be randomized to one of these two arms of the study.
Condições
Lymphoma, Follicular
Elegibilidade
Inclusion Criteria: * Subjects with a diagnosis of CD20 and CD22-positive, follicular lymphoma, who have received 1 or 2 prior regimens, at least 1 of which should have contained administration of rituximab (either as a single agent or in combination). * Age 18 years or older. * ECOG performance status \<= 2. * ANC \>= 1.5 x 10\^9/L (1500/mL) and platelets \>= 75 x 10\^9/L (75,000/mL), serum creatinine \<= 1.5 x ULN and urine protein to creatinine ratio of \<= 0.5, total bilirubin \<= 1.5 x ULN, AST and ALT \<= 2.5 x ULN. * At least 1 measurable disease lesion that is \>= 1.5 cm x 1.5 cm by CT or MRI, in an area of no prior radiation therapy, or documented progression in an area that was previously irradiated. Exclusion Criteria: * Subjects with clinical evidence of transformation to a more aggressive subtype of lymphoma or grade 3b follicular lymphoma. * Subjects whose disease is rituximab refractory, meaning that they did not have a CR or PR, or that they experienced disease progression within 6 months from the initiation of the rituximab or rituximab containing treatment regimen administered immediately preceding study enrollment.