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
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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Complete Response Rate (CR)
Primary endpoint is complete response rate within 6 months
6 Months
No
Andrew M Evens, DO, MSc
Principal Investigator
University of Massachusetts, Worcester
United States: Food and Drug Administration
SPI-MGD-11-201
NCT01549886
November 2011
July 2016
Name | Location |
---|---|
Rush University Medical Center | Chicago, Illinois 60612-3824 |
Providence Saint Joseph Medical Center | Burbank, California 91505-4866 |
Oncology Specialists | Park Ridge, Illinois 60068 |
Loyola University Chicago | Maywood, Illinois 60153 |
University of Massachusetts - Worcester | Worcester, Massachusetts 01655 |
Alta Bates Summit Medical Center-Herrick | Berkeley, California 94704 |
Halifax Health- Center for Oncology | Daytona Beach, Florida 32114 |
Hackensack Medical Center | Hackensack, New Jersey 07601 |
West Virginia University, WVU Healthcare | Morgantown, West Virginia 26506 |