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Bcl-2 inhibitor
APG-2575 for CLL
Phase 1
Recruiting
Research Sponsored by Ascentage Pharma Group Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG ≤2
Adequate bone marrow function independent of growth factor: Absolute neutrophil count (ANC)≥1.0× 109/L in patient without bone marrow involvement. Platelets count ≥30 x 109/L (entry platelet count must be independent of transfusion within 7 days of first dose of study drug)
Must not have
Radiation within 14 days of study entry
Known active hepatitis B infection or known hepatitis C infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 42 days
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new drug, APG-2575, to see if it is safe and how well it works.
Who is the study for?
This trial is for adults over 18 with chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL) who have tried at least one treatment without success and need more therapy. They should be relatively active (ECOG ≤2), show signs of disease progression, and meet specific blood count and organ function criteria.
What is being tested?
The study tests APG-2575 alone or with other treatments to find the safest dose that's still effective for CLL/SLL. It aims to identify any toxic effects at different doses and establish a recommended dosage for future phase 2 trials.
What are the potential side effects?
While not explicitly listed, side effects likely include reactions where the drug is given, changes in blood counts leading to increased infection risk, fatigue, liver issues indicated by enzyme levels, potential bleeding problems shown by INR/PT/APTT values.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and am up and about more than 50% of my waking hours.
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My blood tests show enough neutrophils and platelets without recent transfusions.
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My cancer has worsened recently, shown by tests or symptoms like night sweats or weight loss.
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My kidney and liver are functioning well according to specific blood tests.
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My CLL or SLL has come back or didn't respond to at least one treatment.
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I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not had radiation therapy in the last 14 days.
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I have an active hepatitis B or C infection.
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I have been diagnosed with Richter's Syndrome.
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I do not have any uncontrolled illnesses that could interfere with the study.
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My cancer has spread to my brain or spinal cord.
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I have active graft-versus-host disease or need immunosuppressive therapy.
Select...
I have stomach or intestine problems that could affect how my body absorbs medication.
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I have been diagnosed with HIV.
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My heart condition limits my physical activity.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 42 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~42 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Maximally tolerated dose (MTD)
Primary Toxicity Endpoint: dose limiting toxicity (DLT)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
6Treatment groups
Experimental Treatment
Group I: APG2575 800mgExperimental Treatment1 Intervention
APG2575 800mg ramp up
Group II: APG2575 400mgExperimental Treatment1 Intervention
APG2575 400mg ramp up
Group III: APG2575 200mgExperimental Treatment1 Intervention
APG2575 200mg ramp up
Group IV: APG2575 1200mgExperimental Treatment1 Intervention
APG2575 1200mg ramp up
Group V: APG2575 1000 mgExperimental Treatment1 Intervention
APG2575 1000 mg ramp up
Group VI: APG 2575 600mgExperimental Treatment1 Intervention
APG2575 600mg ramp up
Find a Location
Who is running the clinical trial?
Ascentage Pharma Group Inc.Lead Sponsor
52 Previous Clinical Trials
5,632 Total Patients Enrolled
Yifan Zhai, MD, PhDStudy ChairAscentage Pharma Group Inc.
18 Previous Clinical Trials
1,326 Total Patients Enrolled