Cancer

Title
A Phase III Study of GA101 Plus CVP Chemotherapy Followed by GA101 Maintenance to Compare with Rituximab Plus Chemotherapy Followed by Rituximab Maintenance for Previously Untreated Patients with Advanced Indolent Non-Hodgkin’s Lymphoma
Trial Number
205207061913
Number of Participants
1,400
Principal Investigator

Scott Smith

M.D.,Ph.D., FACP
Hematology/Oncology
Associate Professor
Eligibility

Patients must meet the following criteria for study entry: • Histologically documented, CD20-positive, indolent B-cell non-Hodgkin’s Lymphoma consisting of one of the following: follicular lymphoma (Grades 1-3a), splenic MZL, nodal MZL or extranodal MZL • Stage III or IV disease or Stage II bulky disease = 7 cm. • For patients with symptomatic splenic, nodal or non-gastric extranodal MZL: disease that is de novo or has relapsed following local therapy (i.e., surgery or radiotherapy) and requires therapy, as assessed by the investigator. • For patients with symptomatic gastric extranodal MZL: Helicobacter pylori-negative disease that is de novo or has relapsed following local therapy (i.e., surgery or radiotherapy) and requires therapy, as assessed by the investigator, or H. pylori-positive disease that has remained stable, progressed or relapsed following antibiotic therapy and requires therapy, as assessed by the investigator • At least one bidimensionally measurable lesion (> 2 cm in its largest dimension by CT scan or MRI)

Purpose

The purpose of this study is to compare the effects, good and/or bad, of the experimental drug GA101 combined with one of three types of chemotherapy (cyclophosphamide, doxorubicin, vincristine and prednisone [CHOP]; cyclophosphamide, vincristine and prednisone [CVP]; or bendamustine) followed by GA101 maintenance therapy for two years compared with rituximab combined with one of three types of chemotherapy (CHOP, CVP or bendamustine) followed by rituximab maintenance therapy for two years on CD20-positive, indolent non Hodgkin’s Lymphoma.

Enrollment

(708) 327-3228

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