Chronic Lymphocytic LeukemiaPhase 1NCT03893682
A Study of CG-806 in Patients With Relapsed or Refractory CLL/SLL or Non-Hodgkin's Lymphomas
A Phase 1 study testing CG-806 in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by Aptose Biosciences Inc. at 30 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Non-Hodgkin's Lymphoma
- What is being tested?
- CG-806
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 30 sitesUnited States
- Study dates
- 30 Apr 2019to 17 May 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
30 sites in 1 country.
30 sites in 1 country
United States30 sites
University of Michigan
Ann Arbor, Michigan, 48109
Rocky Mountain Cancer Centers
Aurora, Colorado, 80012
Texas Oncology - Austin-Midtown
Austin, Texas, 78705
University of Maryland, Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, 21201
The Center for Cancer and Blood Disorders a division of American Oncology Partners of Maryland, PA
Bethesda, Maryland, 20817
SCL Health, St. Vincent Frontier Cancer Center
Billings, Montana, 59102
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, 46804
Texas Oncology - Fort Worth Cancer Center
Fort Worth, Texas, 76104
Prisma Health - ITOR
Greenville, South Carolina, 29605
University of Texas, M.D. Anderson Cancer Center
Houston, Texas, 77030
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
University of California Los Angeles
Los Angeles, California, 90095
Pacific Cancer Care
Monterey, California, 93940
Morristown Medical Center
Morristown, New Jersey, 07960
Manhattan Hematology Oncology
New York, New York, 10016
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Virginia Oncology Associates
Norfolk, Virginia, 23502
Orlando Health
Orlando, Florida, 32806
Torrance Memorial Physician Network
Redondo Beach, California, 90277
Mayo Clinic Rochester
Rochester, Minnesota, 55905
Carolina Blood and Cancer Care Associates
Rock Hill, South Carolina, 29732
University of Texas Health Science Center at San Antonio, Mays Cancer Center
San Antonio, Texas, 78229
UCSD Moores Cancer Center
San Diego, California, 92093
Sharp Clinical Oncology Research
San Diego, California, 92123
Ridley-Tree Cancer Center
Santa Barbara, California, 93105
St. Joseph Heritage Heathcare
Santa Rosa, California, 95403
Texas Oncology - Tyler
Tyler, Texas, 75702
Northwest Cancer Specialists, P.C. - Compass Oncology
Vancouver, Washington, 98684
UMass Memorial Medical Center
Worcester, Massachusetts, 01655
About this study
Official title: 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 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.
Read the detailed 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.
- Being tested
- CG-806
- Keywords
- Oral, DLBCL, PMBCL, BCLU, GZL, MCL, FL, MZL, WM, LPL, CLL, SLL
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CG-806Drug
Also called Luxeptinib
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.
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation and Expansion | Experimental | 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. Receives: Drug: CG-806 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events of CG-806
To determine the safety and tolerability of CG-806.
Measured: Cycle 1 (28 days)
Establish a CG-806 dose that maintains a biologically active plasma concentration
To determine the dose of CG-806 given orally every 12 hours that maintains a biologically active plasma concentration over a period of 28 days.
Measured: Cycle 1 (28 days)
Establish recommended dose for future development of CG-806
To establish the recommended Phase 2 dose (RP2D) of CG-806 for future clinical trials in patients with advanced CLL/SLL or NHL.
Measured: Up to 10 months
Secondary outcomes (11)
Pharmacokinetic variables including maximum plasma concentration (Cmax)
Pharmacokinetic variables including maximum plasma concentration (Cmax)
Measured: Cycle 1 (28 days)
Pharmacokinetic variables including minimum plasma concentration (Cmin)
Pharmacokinetic variables including minimum plasma concentration (Cmin)
Measured: Cycle 1 (28 days)
Pharmacokinetic variables including Area Under the Curve (AUC) Pharmacokinetic variables including Area Under the Curve (AUC Pharmacokinetic variables including Area Under the Curve (AUC
Pharmacokinetic variables including Area Under the Curve (AUC)
Measured: Cycle 1 (28 days)
Pharmacokinetic variables including volume of distribution
Pharmacokinetic variables including volume of distribution
Measured: Cycle 1 (28 days)
Pharmacokinetic variables including clearance
Pharmacokinetic variables including clearance
Measured: Cycle 1 (28 days)
Pharmacokinetic variables including serum half-life
Pharmacokinetic variables including serum half-life
Measured: Cycle 1 (28 days)
To assess the antitumor activity of CG-806 using FDG PET-CT imaging evaluations
To assess the antitumor activity of CG-806 using FDG PET-CT imaging evaluations
Measured: Average 2 Cycles (8 weeks)
Pharmacodynamic biomarkers of drug effect including BTK activity
Pharmacodynamic biomarkers of drug effect including BTK activity
Measured: Average 2 cycles (8 weeks)
Pharmacodynamic biomarkers of drug effect including selected mRNA levels
Pharmacodynamic biomarkers of drug effect including selected mRNA levels
Measured: Average 2 cycles (8 weeks)
To assess the relative BA of formulation G1 against formulation G2
To assess the relative bioavailability of original formulation (G1) against new generation formulation (G2).
Measured: Cycle 1 (28 days)
To assess the relative BA of formulation G1 against formulation G3
To assess the relative bioavailability of original formulation (G1) against new generation formulation (G3).
Measured: Cycle 1 Lead-Up (3 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2019
- Study start30 Apr 2019
- Primary completion17 May 2024
- Study completion17 May 2024
Why it stopped: Change in corporate strategy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aptose Biosciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rafael Bejar, MD, PhD, Study director, Aptose Biosciences Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03893682
- Sponsor's protocol ID
- APTO-CG-806-01
- Status last verified
- Mar 2025
- First submitted
- 25 Mar 2019
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ia/b Trial to Evaluate the Safety and Tolerability of CG-806 in Patients With CLL/SLL or Non-Hodgkin's Lymphomas
- ClinicalTrials.gov ID
- NCT03893682
- Acronym / sponsor ID
- APTO-CG-806-01
- Keywords
- Oral, DLBCL, PMBCL, BCLU, GZL, MCL, FL, MZL
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Change in corporate strategy
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Aptose Biosciences Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Apr 2019 (actual)
- Primary completion
- 17 May 2024 (actual)
- Study completion
- 17 May 2024 (actual)
- First posted
- 28 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation and Expansion | Experimental | Drug: CG-806CG-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CG-806Also: LuxeptinibCG-806 will be given orally in ascending doses starting at 150 mg PO BID until the maximum tolerated dose or recommended dose is reached. | Drug | Dose Escalation and Expansion |
Primary outcome
Incidence of treatment-emergent adverse events of CG-806
Time frame: Cycle 1 (28 days)
To determine the safety and tolerability of CG-806.
Establish a CG-806 dose that maintains a biologically active plasma concentration
Time frame: Cycle 1 (28 days)
To determine the dose of CG-806 given orally every 12 hours that maintains a biologically active plasma concentration over a period of 28 days.
Establish recommended dose for future development of CG-806
Time frame: Up to 10 months
To establish the recommended Phase 2 dose (RP2D) of CG-806 for future clinical trials in patients with advanced CLL/SLL or NHL.
11 secondary outcomes
Pharmacokinetic variables including maximum plasma concentration (Cmax)
Time frame: Cycle 1 (28 days)
Pharmacokinetic variables including minimum plasma concentration (Cmin)
Time frame: Cycle 1 (28 days)
Pharmacokinetic variables including Area Under the Curve (AUC) Pharmacokinetic variables including Area Under the Curve (AUC Pharmacokinetic variables including Area Under the Curve (AUC
Time frame: Cycle 1 (28 days)
Pharmacokinetic variables including volume of distribution
Time frame: Cycle 1 (28 days)
Pharmacokinetic variables including clearance
Time frame: Cycle 1 (28 days)
Pharmacokinetic variables including serum half-life
Time frame: Cycle 1 (28 days)
To assess the antitumor activity of CG-806 using FDG PET-CT imaging evaluations
Time frame: Average 2 Cycles (8 weeks)
Pharmacodynamic biomarkers of drug effect including BTK activity
Time frame: Average 2 cycles (8 weeks)
Pharmacodynamic biomarkers of drug effect including selected mRNA levels
Time frame: Average 2 cycles (8 weeks)
To assess the relative BA of formulation G1 against formulation G2
Time frame: Cycle 1 (28 days)
To assess the relative BA of formulation G1 against formulation G3
Time frame: Cycle 1 Lead-Up (3 days)
Results and safety
The study was stopped early (reason given: Change in corporate strategy). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rafael Bejar, MD, PhD study director
Aptose Biosciences Inc.
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CG-806 in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by Aptose Biosciences Inc. at 30 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Change in corporate strategy). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-emergent adverse events of CG-806 (time frame: Cycle 1 (28 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2025.