Non Hodgkin Lymphoma Clinical Trial
A Study of CG-806 in Patients With Relapsed or Refractory CLL/SLL or Non-Hodgkin’s Lymphomas
Summary
This study is being done to evaluate the safety, tolerability and effectiveness of Oral CG-806 for the treatment of patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or Non-Hodgkin's Lymphomas who have failed or are intolerant to two or more lines of established therapy or for whom no other treatment options are available.
Full Description
This is a multicenter, open-label, Phase Ia/b dose escalation study of safety, pharmacodynamics, and pharmacokinetics of CG-806 in ascending cohorts (3+3 design) to determine the MTD or recommended dose in patients with relapsed or refractory CLL/SLL or Non-Hodgkin's Lymphoma patients. This is to be followed by a cohort expansion phase at the MTD or recommended oral dose.
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18 years
Life expectancy of at least 2 months
ECOG Performance Status ≤ 2
Patients must be able to swallow capsules
Adequate hematologic parameters, unless cytopenias are disease caused
Adequate renal, liver and cardiac function parameters
Exclusion Criteria:
Patients with GVHD requiring systemic immunosuppressive therapy
Uncontrolled leptomeningeal disease, auto-immune hemolytic anemia and uncontrolled and clinical significant disease related metabolic disorder
Clinically significant intravascular coagulation
Treatment with other investigational drugs within 14 days prior to first study treatment administration
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There are 30 Locations for this study
Los Angeles California, 90095, United States
Monterey California, 93940, United States
Redondo Beach California, 90277, United States
San Diego California, 92093, United States
San Diego California, 92123, United States
Santa Barbara California, 93105, United States
Santa Rosa California, 95403, United States
Aurora Colorado, 80012, United States
Jacksonville Florida, 32224, United States
Orlando Florida, 32806, United States
Fort Wayne Indiana, 46804, United States
Baltimore Maryland, 21201, United States
Bethesda Maryland, 20817, United States
Worcester Massachusetts, 01655, United States
Ann Arbor Michigan, 48109, United States
Rochester Minnesota, 55905, United States
Billings Montana, 59102, United States
Morristown New Jersey, 07960, United States
New York New York, 10016, United States
New York New York, 10065, United States
Greenville South Carolina, 29605, United States
Rock Hill South Carolina, 29732, United States
Austin Texas, 78705, United States
Dallas Texas, 75246, United States
Fort Worth Texas, 76104, United States
Houston Texas, 77030, United States
San Antonio Texas, 78229, United States
Tyler Texas, 75702, United States
Norfolk Virginia, 23502, United States
Vancouver Washington, 98684, United States
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