A Phase 2 Safety and Efficacy Study of Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma
Interventional
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Disease Response Using Cheson Criteria
Subjects will be monitored for response and disease progression with contrast CT/18FDG-PET scans every two cycles. Each cycle is 28 days. Response to treatment as defined by Cheson criteria will be reported via descriptive statistics. Per Cheson Criteria: Complete Response (CR) is disappearance of all evidence of disease; Partial Response (PR) is regression of measurable disease and no new sites (≥50% decrease in sum of product diameters of up to 6 largest dominant masses and splenic/liver nodules), and no increase in size of other nodes/liver/spleen; reduction in target lesions, no growth of non-target or new lesions; Progression is any new lesion or increase by ≥50% of previously involved sites from the nadir.
1 year
No
United States: Food and Drug Administration
PLX108-03
NCT01217229
December 2010
Name | Location |
---|---|
MD Anderson Cancer Center | Houston, Texas 77030-4096 |
Mayo Clinic | Rochester, Minnesota 55905 |
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
Nebraska Medical Center | Omaha, Nebraska 68198 |
UCLA Jonsson Comprehensive Cancer Center | Los Angeles, California 90095 |
Northwestern University, The Robert H Lurie Comprehensive Cancer Center | Chicago, Illinois 60611 |