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Bcl-2 inhibitor

APG2575 for Chronic Lymphocytic Leukemia

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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 42 days
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 below
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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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~42 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 42 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximally tolerated dose (MTD)
Primary Toxicity Endpoint: dose limiting toxicity (DLT)

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
46 Previous Clinical Trials
4,299 Total Patients Enrolled
Yifan Zhai, MD, PhDStudy ChairAscentage Pharma Group Inc.
18 Previous Clinical Trials
1,271 Total Patients Enrolled

Frequently Asked Questions

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

Is enrollment for the trial open at this time?

"According to the clinicaltrials.gov entry, this trial is presently recruiting participants, with a first posting date of March 2nd 2020 and most recent update on February 28th 2022."

Answered by AI

Are people below the age of eighty-five capable of participating in this clinical experiment?

"As indicated by the trial's eligibility criteria, participants must be between 18 and 85 years old."

Answered by AI

Am I eligible to participate in this medical experiment?

"In order to be admitted into this clinical trial, candidates must suffer from chronic lymphocytic leukemia and fall within the age range of 18-85. 35 participants will ultimately join this medical research project."

Answered by AI

How many venues are involved in the management of this clinical study?

"This research has seven participating sites, such as the City of Hope in Duarte, Dana Farber Cancer Institute in Boston and Gabrail Cancer Center. Additionally there are four other centres taking part."

Answered by AI

Are there any hazardous effects associated with APG2575 use?

"Due to the preliminary nature of this trial, our team at Power gave APG2575 a rating of 1 for safety as data regarding both efficacy and safety is sparse."

Answered by AI

How many participants have thus far enrolled in this clinical experiment?

"A total of 35 participants that meet the necessary qualifications must join this trial. Possible sites for enrollment include City of Hope in Duarte, California and Dana Farber Cancer Institute in Boston, Massachusetts."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of APG-2575 as a Single Agent or in Combination With Other Therapeutic Agents for CLL/SLL
2020. "Study of APG-2575 as a Single Agent or in Combination With Other Therapeutic Agents for CLL/SLL". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04215809.
~6 spots leftby Mar 2025
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