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
This is a phase I study of BTK inhibitor CT-1530 in patients with relapsed or refractory B cell non-Hodgkin lymphoma (B-NHL), chronic lymphocytic leukemia (CLL) or Waldenstrom's macroglobulinemia (WM). The purpose of the study is to determine the MTD/RP2D of CT-1530, and evaluate its safety and tolerability as monotherapy in subjects with relapsed or refractory B cell non-Hodgkin lymphoma (B-NHL), chronic lymphocytic leukemia (CLL) or Waldenstrom's macroglobulinemia (WM).
Phase 1/Phase 2
Incidence rate of dose limiting toxicities (DLTs) during the first cycle of treatment (Phase I)
Overall Response Rate (ORR) - Phase I
Relapsed or Refractory B Cell Non-Hodgkin Lymphoma
Study Arms / Comparison Groups
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
April 1, 2017
Primary Completion Date
Inclusion Criteria: - 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). Exclusion Criteria: - 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 Other protocol-defined inclusion/exclusion criteria may apply
18 Years - 65 Years
Accepts Healthy Volunteers
Yuankai Shi, M.D., 86(10)-88858866, [email protected]
Centaurus Biopharma Co., Ltd.
Yuankai Shi, M.D., Principal Investigator, Cancer Hospital of Chines Academy of Medical Sciences