Chronic Lymphocytic Leukemia, Diffuse Large B Cell Lymphoma, Follicle Centre Lymphoma Diffuse, Mantle Zone Lymphoma Refractory/Recurrent, Relapsed or Refractory B Cell Non-Hodgkin Lymphoma, Waldenstrom's Macroglobulinemia
Conditions
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).
Interventions
DRUGCT-1530
Relapsed or Refractory B Cell Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, Waldenstrom's Macroglobulinemia, FL, Diffuse B-cell lymphoma, Mental-cell lymphoma
Sponsors
Centaurus Biopharma Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Contacts
Primary ContactYong Peng, M.D. & Ph.D
Backup ContactDeng Hou, BS
Outcome results
None listed