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

Phase 1

• Conditions: Relapsed or Refractory B Cell Non-Hodgkin Lymphoma; Waldenstrom's Macroglobulinemia; Chronic Lymphocytic Leukemia; Mantle Zone Lymphoma Refractory/Recurrent; Follicle Centre Lymphoma Diffuse; Diffuse Large B Cell Lymphoma
• Interventions: Drug: CT-1530

• Registration Number: NCT02981745
• Lead Sponsor: Centaurus Biopharma Co., Ltd.

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-12-01
• Study First Submitted QC: 2016-12-01
• Study First Posted: 2016-12-05
• Study Start: 2017-04-01
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-18
• Last Update Posted: 2017-07-19
• Primary Completion: 2018-09
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CT-1530	CT-1530	-

Primary Outcome Measures

Name	Time	Method
Incidence rate of dose limiting toxicities (DLTs) during the first cycle of treatment (Phase I)	28 days	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

Name	Time	Method
Overall Response Rate (ORR) - Phase I	Up to 24 month	Preliminary measure of anti-tumor activity of CT-1530
Progression free survival (PFS) per RECIST v1.1 - Phase I	Up to 24 months	Preliminary measures of anti-tumor activity of CT-1530
Duration of response (DOR)	Up to 24 months	Preliminary measure of anti-tumor activity of CT-707

Trial Locations

Locations (1)

Cancer Hospital of Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China