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



Status:Not yet recruiting
Conditions:Blood Cancer, Lymphoma, Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/30/2019
Start Date:April 2019
End Date:December 2020
Contact:Nicole Harada
Email:nharada@aptose.com
Phone:8589262730

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

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.

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.

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
We found this trial at
3
sites
Bethesda, Maryland 20817
Principal Investigator: Victor Priego, MD
Phone: 301-571-2016
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Monterey, California 93940
Principal Investigator: Laura Stampleman, MD
Phone: 831-375-4105
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Monterey, CA
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San Diego, California 91351
Principal Investigator: Erin Reid, MD
Phone: 858-534-5201
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San Diego, CA
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