Phase 2 Study of Zevalin Versus Zevalin and Motexafin Gadolinium in Patients With Rituximab-Refractory Low-grade or Follicular B-cell Non-Hodgkin's Lymphoma
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 NHL.
Effectiveness of the experimental regimen will be 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.
Drug: Zevalin Regimen
Drug: Moxtezafin Gadolinium
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized, Open-Label, Multi-Center, Phase 2 Study of Zevalin ([90Y]- Ibritumomab Tiuxetan) Versus Zevalin and Motexafin Gadolinium in Patients With Rituximab- Refractory Low-grade or Follicular B-cell Non-Hodgkin's Lymphoma|
- Complete Response Rate (CR) [ Time Frame: 6 Months ] [ Designated as safety issue: No ]Primary endpoint is complete response rate within 6 months
- Overall Response Rate [ Time Frame: 3 Months and 6 Months ] [ Designated as safety issue: No ]Complete response rate within 3 months, overall response rate within 6 months and progression-free survival.
- Safety [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]Treatment-emergent adverse events, deaths and other serious adverse events, adverse events resulting in withdrawal of patient, ad laboratory abnormalities.
|Study Start Date:||November 2011|
|Estimated Study Completion Date:||July 2016|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Experimental: Moxtezafin Gadolinium
Experimental Arm with Moxtezafin Gadolinium and Zevalin Regimen
Drug: Moxtezafin Gadolinium
Day 1-4 Motexafin gadolinium 5 mg/kg intravenously once daily, followed in one hour (Day 1 only) by Day 1 Rituximab 250 mg/m2 intravenous infusion.
Day 8-11 Motexafin gadolinium 5 mg/kg intravenously once daily, followed in one hour (Day 8 only) by Day 8 Rituximab 250 mg/m2 intravenous infusion, followed 4 hours later by Y-90-Zevalin 0.4 mCi/kg 10-minute intravenous push (0.3 mCi/kg in patients with a platelet count in 100,000/μL to 149,000/μL.
Other Name: MGD
Active Comparator: Zevalin Regimen
Day 1 Rituximab 250 mg/m2 intravenous infusion. Day 8 Rituximab 250 mg/m2 intravenous infusion, followed 4 hours later by Y-90-Zevalin 0.4 mCi/kg 10-minute intravenous push (0.3 mCi/kg in patients with a platelet count in 100,000/μL to 149,000/μL.)
Drug: Zevalin Regimen
Day 1 - Rituximab 250 mg/m2 intravenous infusion. Day 8 - Rituximab 250 mg/m2 intravenous infusion, followed 4 hours later by Y-90-Zevalin 0.4 mCi/kg 10-minute intravenous push
Other Name: Rituximab + [90Y]- ibritumomab tiuxetan (Zevalin)
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 will be enrolled in the study (approximately 50 in each group at 15 clinical sites in North America).
Patients will be 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 will be randomized 1:1 to receive either Zevalin or Zevalin and motexafin gadolinium.
Patients will be 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 will be performed at Month 12.
Disease status will be assessed using positron emission tomography (PET) or PET/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 will be assessed are complete response rate and overall response rate.
Safety will be assessed by adverse events, physical examinations, vital signs, and clinical laboratory assessments. Serious adverse events (SAEs) and treatment-emergent adverse events(TEAEs) will be 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.
|United States, California|
|Alta Bates Summit Medical Center-Herrick|
|Berkeley, California, United States, 94704|
|Providence Saint Joseph Medical Center|
|Burbank, California, United States, 91505|
|United States, Florida|
|Halifax Health- Center for Oncology|
|Daytona Beach, Florida, United States, 32114|
|United States, Illinois|
|Rush University Medical Center|
|Chicago, Illinois, United States, 60612|
|Loyola University Chicago|
|Maywood, Illinois, United States, 60153|
|Park Ridge, Illinois, United States, 60068|
|United States, Massachusetts|
|University of Massachusetts - Worcester|
|Worcester, Massachusetts, United States, 01655|
|United States, New Jersey|
|Hackensack Medical Center|
|Hackensack, New Jersey, United States, 07601|
|United States, West Virginia|
|West Virginia University, WVU Healthcare|
|Morgantown, West Virginia, United States, 26506|
|Principal Investigator:||Andrew M Evens, DO, MSc||University of Massachusetts, Worcester|