Non Hodgkin Lymphoma Clinical Trial

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

Summary

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.

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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.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

160

Study ID:

NCT03893682

Recruitment Status:

Active, not recruiting

Sponsor:

Aptose Biosciences Inc.

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There are 30 Locations for this study

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University of California Los Angeles
Los Angeles California, 90095, United States
Pacific Cancer Care
Monterey California, 93940, United States
Torrance Memorial Physician Network
Redondo Beach California, 90277, United States
UCSD Moores Cancer Center
San Diego California, 92093, United States
Sharp Clinical Oncology Research
San Diego California, 92123, United States
Ridley-Tree Cancer Center
Santa Barbara California, 93105, United States
St. Joseph Heritage Heathcare
Santa Rosa California, 95403, United States
Rocky Mountain Cancer Centers
Aurora Colorado, 80012, United States
Mayo Clinic Jacksonville
Jacksonville Florida, 32224, United States
Orlando Health
Orlando Florida, 32806, United States
Fort Wayne Medical Oncology and Hematology
Fort Wayne Indiana, 46804, United States
University of Maryland, Greenebaum Comprehensive Cancer Center
Baltimore Maryland, 21201, United States
The Center for Cancer and Blood Disorders a division of American Oncology Partners of Maryland, PA
Bethesda Maryland, 20817, United States
UMass Memorial Medical Center
Worcester Massachusetts, 01655, United States
University of Michigan
Ann Arbor Michigan, 48109, United States
Mayo Clinic Rochester
Rochester Minnesota, 55905, United States
SCL Health, St. Vincent Frontier Cancer Center
Billings Montana, 59102, United States
Morristown Medical Center
Morristown New Jersey, 07960, United States
Manhattan Hematology Oncology
New York New York, 10016, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
Prisma Health - ITOR
Greenville South Carolina, 29605, United States
Carolina Blood and Cancer Care Associates
Rock Hill South Carolina, 29732, United States
Texas Oncology - Austin-Midtown
Austin Texas, 78705, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas Texas, 75246, United States
Texas Oncology - Fort Worth Cancer Center
Fort Worth Texas, 76104, United States
University of Texas, M.D. Anderson Cancer Center
Houston Texas, 77030, United States
University of Texas Health Science Center at San Antonio, Mays Cancer Center
San Antonio Texas, 78229, United States
Texas Oncology - Tyler
Tyler Texas, 75702, United States
Virginia Oncology Associates
Norfolk Virginia, 23502, United States
Northwest Cancer Specialists, P.C. - Compass Oncology
Vancouver Washington, 98684, United States

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

160

Study ID:

NCT03893682

Recruitment Status:

Active, not recruiting

Sponsor:


Aptose Biosciences Inc.

How clear is this clinincal trial information?

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