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

NCT02981745 | Unknown Phase 1 DMC

• 1 other identifier: CT-1530-101
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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).

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Overall Response Rate (ORR) - Phase I

  Up to 24 month

• Progression free survival (PFS) per RECIST v1.1 - Phase I

  Up to 24 months

• Duration of response (DOR)

  Up to 24 months

Study Arms (1)

CT-1530

EXPERIMENTAL

Drug: CT-1530

Interventions

CT-1530 DRUG

Relapsed or Refractory B Cell Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, Waldenstrom's Macroglobulinemia, FL, Diffuse B-cell lymphoma, Mental-cell lymphoma

CT-1530

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Centaurus Biopharma Co., Ltd.: lead

Study Sites (1)

Cancer Hospital of Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Conditions

Recurrence; Lymphoma, B-Cell; Leukemia, Lymphocytic, Chronic, B-Cell; Waldenstrom Macroglobulinemia; Lymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Hematologic Diseases; Chronic Disease; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders

Study Officials

• Yuankai Shi, M.D.

  Cancer Hospital of Chines Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yong Peng, M.D. & Ph.D

CONTACT

86(10)-88858866; ypeng@centaurusbio.com

Deng Hou, BS

CONTACT

86(10)-88858866; dhou@centaurusbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2016
• First Posted: December 5, 2016
• Study Start: April 1, 2017
• Primary Completion: September 1, 2018
• Study Completion: December 1, 2018
• Last Updated: July 19, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)