Clinical trial NCT02981745: 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
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: 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
Lead sponsor: Centaurus Biopharma Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-12-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Incidence rate of dose limiting toxicities (DLTs) during the first cycle of treatment (Phase I)
timeFrame: 28 days
Secondary outcomes:
measure: Overall Response Rate (ORR) - Phase I
timeFrame: Up to 24 month
measure: Progression free survival (PFS) per RECIST v1.1 - Phase I
timeFrame: Up to 24 months
measure: Duration of response (DOR)
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital of Chinese Academy of Medical Sciences
state: Beijing
Study officials:
affiliation: Cancer Hospital of Chines Academy of Medical Sciences
name: Yuankai Shi, M.D.
role: PRINCIPAL_INVESTIGATOR
References: