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
Primary Purpose
Relapsed or Refractory B Cell Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, Waldenstrom's Macroglobulinemia
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
CT-1530
Sponsored by
About this trial
This is an interventional treatment trial for Relapsed or Refractory B Cell Non-Hodgkin Lymphoma
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
Sites / Locations
- Cancer Hospital of Chinese Academy of Medical SciencesRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CT-1530
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Overall Response Rate (ORR) - Phase I
Preliminary measure of anti-tumor activity of CT-1530
Progression free survival (PFS) per RECIST v1.1 - Phase I
Preliminary measures of anti-tumor activity of CT-1530
Duration of response (DOR)
Preliminary measure of anti-tumor activity of CT-707
Full Information
NCT ID
NCT02981745
First Posted
December 1, 2016
Last Updated
July 18, 2017
Sponsor
Centaurus Biopharma Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02981745
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
September 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centaurus Biopharma Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CT-1530
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
CT-1530
Intervention Description
Relapsed or Refractory B Cell Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, Waldenstrom's Macroglobulinemia, FL, Diffuse B-cell lymphoma, Mental-cell lymphoma
Primary Outcome Measure Information:
Title
Incidence rate of dose limiting toxicities (DLTs) during the first cycle of treatment (Phase I)
Description
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
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Overall Response Rate (ORR) - Phase I
Description
Preliminary measure of anti-tumor activity of CT-1530
Time Frame
Up to 24 month
Title
Progression free survival (PFS) per RECIST v1.1 - Phase I
Description
Preliminary measures of anti-tumor activity of CT-1530
Time Frame
Up to 24 months
Title
Duration of response (DOR)
Description
Preliminary measure of anti-tumor activity of CT-707
Time Frame
Up to 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yong Peng, M.D. & Ph.D
Phone
86(10)-88858866
Email
ypeng@centaurusbio.com
First Name & Middle Initial & Last Name or Official Title & Degree
Deng Hou, BS
Phone
86(10)-88858866
Email
dhou@centaurusbio.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuankai Shi, M.D.
Organizational Affiliation
Cancer Hospital of Chines Academy of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Hospital of Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuankai Shi, MD
Phone
86(10)67781331
Email
syuankaipumc@126.com
First Name & Middle Initial & Last Name & Degree
Yuankai Shi, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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
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