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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

Must not have

Uncontrolled leptomeningeal disease, auto-immune hemolytic anemia and uncontrolled and clinical significant disease related metabolic disorder

Patients with GVHD requiring systemic immunosuppressive therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 10 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have uncontrolled brain or spinal cord disease, autoimmune blood disorders, or severe metabolic issues.

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I have GVHD and need drugs to suppress my immune system.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 5Eligibility criteria met