The objectives of this study are to evaluate the efficacy and safety of the Zevalin regimen compared to Zevalin and motexafin gadolinium in patients with rituximab-refractory, low-grade or follicular Non-Hodgkin's Lymphoma (NHL). Effectiveness of the experimental regimen assessed by complete response rate within 6 months of study entry (primary endpoint), complete response rate within 3 months of study entry, and overall response rate within 6 month of study entry.
This multi-center, randomized, open-label study is designed to compare the safety and efficacy of therapy with Zevalin regimen versus Zevalin and motexafin gadolinium in patients with rituximab-refractory, low-grade or follicular NHL. Approximately 100 adult patients enrolled in the study (approximately 50 in each group at 15 clinical sites in North America). Patients screened for eligibility within the 14 days prior to Day 1 of the study. Once written informed consent has been obtained and patient eligibility has been established, the patient randomized 1:1 to receive either Zevalin or Zevalin and motexafin gadolinium. Patients assessed for safety at each visit to the study center and for disease response at Months 3, 6 and 12. An end-of-study-visit performed at Month 12. Disease status assessed using positron emission tomography (PET) or PET/computerized tomography (CT), and/or flow cytometry. Disease response will be evaluated in accordance with the standardized definitions and criteria of the International Working Group Revised Response Criteria for Malignant Lymphoma. The efficacy endpoints that assessed are complete response rate and overall response rate. Safety was assessed by adverse events, physical examinations, vital signs, and clinical laboratory assessments. Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) was collected for all patients beginning on Day 1 and continuing through the end-of study-visit to be performed at Month 12 or withdrawal from study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
5
Day 8 - Y-90-Zevalin 0.4 mCi/kg 10-minute intravenous push
Day 1-4 Motexafin gadolinium 5 mg/kg intravenously once daily, followed in one hour (Day 1 only) by Day 1 Rituximab 250 mg/m\^2 intravenous infusion. Day 8-11 Motexafin gadolinium 5 mg/kg intravenously once daily
Day 1 and Day 8: Rituximab 250 mg/m\^2 intravenous infusion
Alta Bates Summit Medical Center-Herrick
Berkeley, California, United States
Providence Saint Joseph Medical Center
Burbank, California, United States
Halifax Health- Center for Oncology
Daytona Beach, Florida, United States
Rush University Medical Center
Chicago, Illinois, United States
Loyola University Chicago
Maywood, Illinois, United States
Oncology Specialists
Park Ridge, Illinois, United States
University of Massachusetts - Worcester
Worcester, Massachusetts, United States
Hackensack Medical Center
Hackensack, New Jersey, United States
West Virginia University, WVU Healthcare
Morgantown, West Virginia, United States
Complete Response Rate (CR)
Time frame: 6 Months
Overall Response Rate
Complete response rate within 3 months, overall response rate within 6 months and progression-free survival.
Time frame: 3 Months and 6 Months
Number of Participants With Serious Adverse Events and Non-Serious Adverse Events
An Adverse Events (AE) was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. Non-SAEs was an AE events that are not Serious Adverse Events.
Time frame: From time of dosing until 2 years
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