Clareo Health | Study of Safety,Efficacy and Pharmacokinetics of CT-1530 in Patients With Relapsed or Refractory B Cell Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, and Waldenstrom's Macroglobulinemia
Study of Safety,Efficacy and Pharmacokinetics of CT-1530 in Patients With Relapsed or Refractory B Cell Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, and Waldenstrom's Macroglobulinemia
Confirmed diagnosis of B cell Non-Hodgkin Lymphoma(according to World Health Organization \[WHO\] classification)including Chronic Lymphocytic Leukemia/Small cell Lymphocytic Leukemia (International Workshop),or Waldenstrom's Macroglobulinemia(Second International Workshop).
Have failed ≥1 previous treatment for B-NHL/CLL/WM, and have relapsed or refractory disease following last prior treatment.
Eastern Cooperative Oncology Group performance status of ≤ 1 and a life expectancy of at least 3 months.
Measurable disease as per RECIST v1.1
Availability of tumor sample
Adequate hematologic function, as defined by neutrophils ≥ 1.0 x 10\^9/L and platelets ≥ 50 x 10\^9/L; patients with neutrophils \< 1.0 x 10\^9/L due to marrow infiltration are allowed to receive growth factors to bring pre-treatment neutrophils to ≥ 1.0 x 10\^9/L.
Adequate renal function, as defined by creatinine clearance of ≥ 50 ml/min (as estimated by the Cockcroft-Gault equation or as measured by nuclear medicine scan or 24 hour urine collection).
Adequate liver function, as defined by AST and ALT ≤ 3 x ULN, and bilirubin ≤ 1.5 x ULN (unless documented Gilbert's syndrome).
You may not be if
Prior allogeneic bone marrow transplant
Autologous stem cell transplant within 3 months of screening
Active central nervous system involvement
Subjects with autoimmune hemolytic anemia or immune thrombocytopenia
Prior treatment with a Btk inhibitor
Active uncontrolled infection
History of malabsorption
Uncontrolled illness, i.e cardiac, endocrine, respiratory, etc.
History of myocardial infarction, acute coronary syndromes, coronary angioplasty and/or stenting with in the previous 6 months
History of another currently active cancer
History of major surgery within 4 weeks or minor surgery within 1 week
Other medical or psychiatric illness or organ dysfunction
HIV positive
Positive for Hepatitis B surface antigen or Hepatitis C-virus
