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
NCT02981745 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 200
Last updated 2017-07-19
Summary
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).
Conditions
- Relapsed or Refractory B Cell Non-Hodgkin Lymphoma
- Chronic Lymphocytic Leukemia
- Waldenstrom's Macroglobulinemia
- Mantle Zone Lymphoma Refractory/Recurrent
- Follicle Centre Lymphoma Diffuse
- Diffuse Large B Cell Lymphoma
Interventions
- DRUG
-
CT-1530
Relapsed or Refractory B Cell Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, Waldenstrom's Macroglobulinemia, FL, Diffuse B-cell lymphoma, Mental-cell lymphoma
Sponsors & Collaborators
-
Centaurus Biopharma Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Yuankai Shi, M.D. · Cancer Hospital of Chines Academy of Medical Sciences
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-04-01
- Primary Completion
- 2018-09-30
- Completion
- 2018-12-31
Countries
- China
Study Locations
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