Brief Title
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
Official Title
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
Brief 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).
Study Phase
Phase 1/Phase 2
Study Type
Interventional
Primary Outcome
Incidence rate of dose limiting toxicities (DLTs) during the first cycle of treatment (Phase I)
Secondary Outcome
Overall Response Rate (ORR) - Phase I
Condition
Relapsed or Refractory B Cell Non-Hodgkin Lymphoma
Intervention
CT-1530
Study Arms / Comparison Groups
CT-1530
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
200
Start Date
April 1, 2017
Completion Date
December 2018
Primary Completion Date
September 2018
Eligibility Criteria
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
Gender
All
Ages
18 Years - 65 Years
Accepts Healthy Volunteers
No
Contacts
Yuankai Shi, M.D., 86(10)-88858866, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT02981745
Organization ID
CT-1530-101
Responsible Party
Sponsor
Study Sponsor
Centaurus Biopharma Co., Ltd.
Study Sponsor
Yuankai Shi, M.D., Principal Investigator, Cancer Hospital of Chines Academy of Medical Sciences
Verification Date
July 2017