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

NCT ID: NCT03893682

Last Updated: 2025-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-30

Study Completion Date

2024-05-17

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma Non-Hodgkin's Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dose Escalation and Expansion

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.

Group Type EXPERIMENTAL

CG-806

Intervention Type DRUG

CG-806 will be given orally in ascending doses starting at 150 mg PO BID until the maximum tolerated dose or recommended dose is reached.

Interventions

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CG-806

CG-806 will be given orally in ascending doses starting at 150 mg PO BID until the maximum tolerated dose or recommended dose is reached.

Intervention Type DRUG

Other Intervention Names

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Luxeptinib

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aptose Biosciences Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rafael Bejar, MD, PhD

Role: STUDY_DIRECTOR

Aptose Biosciences Inc.

Locations

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University of California Los Angeles

Los Angeles, California, United States

Site Status

Pacific Cancer Care

Monterey, California, United States

Site Status

Torrance Memorial Physician Network

Redondo Beach, California, United States

Site Status

UCSD Moores Cancer Center

San Diego, California, United States

Site Status

Sharp Clinical Oncology Research

San Diego, California, United States

Site Status

Ridley-Tree Cancer Center

Santa Barbara, California, United States

Site Status

St. Joseph Heritage Heathcare

Santa Rosa, California, United States

Site Status

Rocky Mountain Cancer Centers

Aurora, Colorado, United States

Site Status

Mayo Clinic Jacksonville

Jacksonville, Florida, United States

Site Status

Orlando Health

Orlando, Florida, United States

Site Status

Fort Wayne Medical Oncology and Hematology

Fort Wayne, Indiana, United States

Site Status

University of Maryland, Greenebaum Comprehensive Cancer Center

Baltimore, Maryland, United States

Site Status

The Center for Cancer and Blood Disorders a division of American Oncology Partners of Maryland, PA

Bethesda, Maryland, United States

Site Status

UMass Memorial Medical Center

Worcester, Massachusetts, United States

Site Status

University of Michigan

Ann Arbor, Michigan, United States

Site Status

Mayo Clinic Rochester

Rochester, Minnesota, United States

Site Status

SCL Health, St. Vincent Frontier Cancer Center

Billings, Montana, United States

Site Status

Morristown Medical Center

Morristown, New Jersey, United States

Site Status

Manhattan Hematology Oncology

New York, New York, United States

Site Status

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

Prisma Health - ITOR

Greenville, South Carolina, United States

Site Status

Carolina Blood and Cancer Care Associates

Rock Hill, South Carolina, United States

Site Status

Texas Oncology - Austin-Midtown

Austin, Texas, United States

Site Status

Texas Oncology - Baylor Charles A. Sammons Cancer Center

Dallas, Texas, United States

Site Status

Texas Oncology - Fort Worth Cancer Center

Fort Worth, Texas, United States

Site Status

University of Texas, M.D. Anderson Cancer Center

Houston, Texas, United States

Site Status

University of Texas Health Science Center at San Antonio, Mays Cancer Center

San Antonio, Texas, United States

Site Status

Texas Oncology - Tyler

Tyler, Texas, United States

Site Status

Virginia Oncology Associates

Norfolk, Virginia, United States

Site Status

Northwest Cancer Specialists, P.C. - Compass Oncology

Vancouver, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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APTO-CG-806-01

Identifier Type: -

Identifier Source: org_study_id

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