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A Study of CG-806 in Patients With Relapsed or Refractory CLL / SLL or Non-Hodgkin's Lymphomas

Trial Status: Active

This study is being done to evaluate the safety, tolerability and effectiveness of Oral CG-806 for the treatment of patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or Non-Hodgkin's Lymphomas who have failed or are intolerant to two or more lines of established therapy or for whom no other treatment options are available.

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Arizona

Scottsdale
Mayo Clinic in Arizona
Status: ACTIVE

California

Los Angeles
Translational Research In Oncology - US Inc
Status: ACTIVE
Contact: Herbert Aaron Eradat
UCLA / Jonsson Comprehensive Cancer Center
Status: ACTIVE
Contact: April Johnson
Phone: 949-653-2959ext118
San Diego
University of California San Diego
Status: ACTIVE

Florida

Jacksonville
Mayo Clinic in Florida
Status: ACTIVE

Maryland

Baltimore
University of Maryland / Greenebaum Cancer Center
Status: ACTIVE
Contact: Janaiya Samuels
Phone: 410-328-8199

Michigan

Ann Arbor
University of Michigan Comprehensive Cancer Center
Status: ACTIVE

Minnesota

Rochester
Mayo Clinic in Rochester
Status: ACTIVE

New York

New York
Memorial Sloan Kettering Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Lindsey Elizabeth Roeker
Phone: 646-608-4115

Texas

Houston
M D Anderson Cancer Center
Status: ACTIVE
Contact: Janel Mitchell
Phone: 713-563-4354
San Antonio
Cancer Therapy and Research Center at The UT Health Science Center at San Antonio
Status: ACTIVE
Contact: Sonia Lisa Creighton
Phone: 210-450-1366

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 oral dose.

Trial Phase Phase I

Trial Type Treatment

Lead Organization
Aptose Biosciences

  • Primary ID APTO-CG-806-01
  • Secondary IDs NCI-2019-04858
  • Clinicaltrials.gov ID NCT03893682