Summary

for people ages 18 years and up (full criteria)
at San Diego, California and other locations
study started
estimated completion
Erin Reid, MD

Description

Summary

This study is being done to evaluate the safety, tolerability and effectiveness of CG-806 for the treatment of patients with the condition of chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or Non-Hodgkin's Lymphomas for which either the standard treatment has failed, is no longer effective, or can no longer be administered safely or poses a risk for your general well being.

Official Title

A Phase Ia/b Trial to Evaluate the Safety and Tolerability of CG-806 in Patients With CLL/SLL or Non-Hodgkin's Lymphomas

Details

This is a multicenter, open-label, Phase Ia/b dose escalation study of safety, pharmacodynamics, and pharmacokinetics of CG-806 in ascending cohorts (3+3 design) to determine the MTD or recommended dose in patients with relapsed or refractory CLL/SLL or Non-Hodgkin's Lymphoma patients. This is to be followed by a cohort expansion phase at the MTD or recommended dose.

Keywords

Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma Non-Hodgkin's Lymphoma Lymphoma Lymphoma, Non-Hodgkin Leukemia, Lymphoid Leukemia, Lymphocytic, Chronic, B-Cell Dose Escalation and Expansion

Eligibility

You can join if…

Open to people ages 18 years and up

  • Age ≥ 18 years
  • Life expectancy of at least 2 months
  • ECOG Performance Status ≤ 2
  • Patients must be able to swallow capsules
  • Adequate hematologic parameters, unless cytopenias are disease caused
  • Adequate renal, liver and cardiac function parameters

You CAN'T join if...

  • Patients with GVHD requiring systemic immunosuppressive therapy
  • Uncontrolled leptomeningeal disease, auto-immune hemolytic anemia and uncontrolled and clinical significant disease related metabolic disorder
  • Clinically significant intravascular coagulation
  • Treatment with other investigational drugs within 14 days prior to first study treatment administration

Locations

  • UCSD Moores Cancer Center not yet accepting patients
    San Diego California 92093 United States
  • Sharp Clinical Oncology Research not yet accepting patients
    San Diego California 92123 United States

Lead Scientist

  • Erin Reid, MD
    Dr. Reid’s broad research interests are to develop and conduct clinical trials for hematologic malignancies. She has made significant progress in the developing a concentration on AIDS-related lymphoma and Kaposi’s sarcoma. Fellow - Hematology-Oncology, Stanford University - 2001-2003 Fellow - Hematology-Oncology, University of California, San Diego - 2004

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Aptose Biosciences Inc.
ID
NCT03893682
Phase
Phase 1
Study Type
Interventional
Last Updated