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

Chronic Lymphocytic Leukemia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02981745
• Other study ID #: CT-1530-101
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: December 1, 2016
• Last updated: July 18, 2017
• Start date: April 1, 2017
• Est. completion date: December 2018

Study information

• Verified date: July 2017
• Source: Centaurus Biopharma Co., Ltd.
• Contact: Yong Peng, M.D. & Ph.D
• Phone: 86(10)-88858866
• Email: ypeng[@]centaurusbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Diffuse Large B Cell Lymphoma
• Follicle Centre Lymphoma Diffuse
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Follicular
• Lymphoma, Large B-Cell, Diffuse
• Lymphoma, Mantle-Cell
• Lymphoma, Non-Hodgkin
• Mantle Zone Lymphoma Refractory/Recurrent
• Relapsed or Refractory B Cell Non-Hodgkin Lymphoma
• Waldenstrom Macroglobulinemia
• Waldenstrom's Macroglobulinemia

Intervention

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

Locations

Country	Name	City	State
China	Cancer Hospital of Chinese Academy of Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Centaurus Biopharma Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence rate of dose limiting toxicities (DLTs) during the first cycle of treatment (Phase I)	Maximum Tolerated Dose(s) (MTD(s)) and/or recommended phase 2 dose (RP2D(s)) of CT-1530 in Subjects With Relapsed or Refractory B Cell Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, Mental-cell lymphoma, Diffuse large B-cell lymphoma, FL and Waldenstrom's Macroglobulinemia	28 days
Secondary	Overall Response Rate (ORR) - Phase I	Preliminary measure of anti-tumor activity of CT-1530	Up to 24 month
Secondary	Progression free survival (PFS) per RECIST v1.1 - Phase I	Preliminary measures of anti-tumor activity of CT-1530	Up to 24 months
Secondary	Duration of response (DOR)	Preliminary measure of anti-tumor activity of CT-707	Up to 24 months