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

Aptose Biosciences

Status and phase: Active, not recruiting; Phase 1

Conditions: Non-Hodgkin's Lymphoma; Small Lymphocytic Lymphoma; Chronic Lymphocytic Leukemia

Treatments: Drug: CG-806

Study type: Interventional

Funder types: Industry

Identifiers

NCT03893682

APTO-CG-806-01

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

---

160 participants in 1 patient group

Dose Escalation and Expansion

Experimental group

Description:

CG-806 will be given orally in ascending doses in patients with relapsed or refractory CLL/SLL or Non-Hodgkin's Lymphomas (escalation cohort), until the maximum tolerated dose or recommended dose is reached. Followed by up to 100 patients enrolled in the expansion cohort at the recommended dose.

Treatment:

Drug: CG-806