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Tyrosine Kinase Inhibitor

CG-806 for Leukemia and Non-Hodgkin's Lymphoma

Phase 1

Waitlist Available

Research Sponsored by Aptose Biosciences Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18 years

ECOG Performance Status ≤ 2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 10 months

Awards & highlights

Study Summary

This trial is testing a new drug for people with leukemia who haven't responded to other treatments.

Who is the study for?

This trial is for adults over 18 with chronic lymphocytic leukemia, small lymphocytic lymphoma, or Non-Hodgkin's Lymphomas who haven't responded to at least two treatments. They must be able to swallow pills and have a life expectancy of more than 2 months. People with severe immune conditions, blood clotting issues, uncontrolled brain disease or anemia are not eligible.Check my eligibility

What is being tested?

The study tests the safety and effectiveness of CG-806 taken orally by patients with certain types of blood cancers that have not improved after previous therapies or when no other treatment options exist.See study design

What are the potential side effects?

Potential side effects include issues related to the digestive system (like nausea), impact on blood cells leading to increased infection risk or bleeding problems, liver function changes, and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I can take care of myself and am up and about more than half of my waking hours.

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I can swallow pills.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 10 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 10 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Establish a CG-806 dose that maintains a biologically active plasma concentration

Establish recommended dose for future development of CG-806

Incidence of treatment-emergent adverse events of CG-806

Secondary outcome measures

Pharmacodynamic biomarkers of drug effect including BTK activity

Pharmacodynamic biomarkers of drug effect including selected mRNA levels

Pharmacokinetic variables including Area Under the Curve (AUC) Pharmacokinetic variables including Area Under the Curve (AUC Pharmacokinetic variables including Area Under the Curve (AUC

+8 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Dose Escalation and ExpansionExperimental Treatment1 Intervention

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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Aptose Biosciences Inc.Lead Sponsor

7 Previous Clinical Trials

825 Total Patients Enrolled

Rafael Bejar, MD, PhDStudy DirectorAptose Biosciences Inc.

1 Previous Clinical Trials

80 Total Patients Enrolled

Media Library

CG-806 (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03893682 — Phase 1

Chronic Lymphocytic Leukemia Research Study Groups: Dose Escalation and Expansion

Chronic Lymphocytic Leukemia Clinical Trial 2023: CG-806 Highlights & Side Effects. Trial Name: NCT03893682 — Phase 1

CG-806 (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03893682 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the total estimated number of participants recruited for this research study?

"160 individuals who meet the specified requirements are necessary for this research. Participants can join from various locations including University of Texas Health Science Center at San Antonio, Mays Cancer Center in San Antonio, and Rocky Mountain Cancer Centers in Aurora, Colorado."

Answered by AI

What results is this research endeavor attempting to achieve?

"According to the data released by Aptose Biosciences Inc., this clinical trial aims to establish a CG-806 dosage that will maintain an effective plasma concentration over 28 days, which is Cycle 1. Additionally, secondary endpoints such as FDG PET-CT imaging evaluations and various pharmacokinetic variables including serum half-life and Area Under the Curve (AUC) will also be tracked for analysis."

Answered by AI

Is there currently an opportunity to join this investigation?

"The information posted on clinicaltrials.gov illustrates that this trial is still recruitting subjects. The original posting date was April 30th 2019 and the most recent update occurred March 28th 2022."

Answered by AI

Has CG-806 completed the necessary regulatory guidelines to receive FDA authorization?

"CG-806 has only undergone limited testing, so its safety rating is a conservative 1 on our scale."

Answered by AI

Are there multiple sites within this urban area carrying out the clinical trial?

"This clinical trial is being held at the University of Texas Health Science Center in San Antonio, Mays Cancer Centre located in San Antonio, Rocky Mountain Cancer Centers situated in Aurora (Colorado), and Mayo Clinic Jacksonville found near Jacksonville. Additionally, there are other 18 research centres participating."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2019. "A Study of CG-806 in Patients With Relapsed or Refractory CLL/SLL or Non-Hodgkin's Lymphomas". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03893682.

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