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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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ClinicalTrials.gov Identifier: NCT02981745
Recruitment Status : Unknown
Verified July 2017 by Centaurus Biopharma Co., Ltd..
Recruitment status was:  Recruiting
First Posted : December 5, 2016
Last Update Posted : July 19, 2017
Sponsor:
Information provided by (Responsible Party):
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).


Condition or disease Intervention/treatment Phase
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 Drug: CT-1530 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 1, 2017
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : December 2018


Arm Intervention/treatment
Experimental: CT-1530 Drug: CT-1530
Relapsed or Refractory B Cell Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, Waldenstrom's Macroglobulinemia, FL, Diffuse B-cell lymphoma, Mental-cell lymphoma




Primary Outcome Measures :
  1. Incidence rate of dose limiting toxicities (DLTs) during the first cycle of treatment (Phase I) [ Time Frame: 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 :
  1. Overall Response Rate (ORR) - Phase I [ Time Frame: Up to 24 month ]
    Preliminary measure of anti-tumor activity of CT-1530

  2. Progression free survival (PFS) per RECIST v1.1 - Phase I [ Time Frame: Up to 24 months ]
    Preliminary measures of anti-tumor activity of CT-1530

  3. Duration of response (DOR) [ Time Frame: Up to 24 months ]
    Preliminary measure of anti-tumor activity of CT-707



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02981745


Contacts
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Contact: Yong Peng, M.D. & Ph.D 86(10)-88858866 ypeng@centaurusbio.com
Contact: Deng Hou, BS 86(10)-88858866 dhou@centaurusbio.com

Locations
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China, Beijing
Cancer Hospital of Chinese Academy of Medical Sciences Recruiting
Beijing, Beijing, China, 100021
Contact: Yuankai Shi, MD    86(10)67781331    syuankaipumc@126.com   
Principal Investigator: Yuankai Shi, MD         
Sponsors and Collaborators
Centaurus Biopharma Co., Ltd.
Investigators
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Principal Investigator: Yuankai Shi, M.D. Cancer Hospital of Chines Academy of Medical Sciences

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Responsible Party: Centaurus Biopharma Co., Ltd.
ClinicalTrials.gov Identifier: NCT02981745     History of Changes
Other Study ID Numbers: CT-1530-101
First Posted: December 5, 2016    Key Record Dates
Last Update Posted: July 19, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma
Leukemia
Lymphoma, Non-Hodgkin
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Waldenstrom Macroglobulinemia
Lymphoma, Follicular
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Neoplasms, Plasma Cell
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders