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Bcl-2 inhibitor

APG-2575 + Azacitidine for Acute Myeloid Leukemia

Phase 1 & 2
Recruiting
Led By Xuemi Sun, MD
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
MPAL will include biphenotypic leukemia, bilineal leukemia, undifferentiated leukemia, mixed lineage leukemia, leukemia of ambiguous lineage, T/myeloid leukemia, B/myeloid leukemia, or other diagnosis indicating the presence of multiple lineages within the cell population.
Patients with a diagnosis of histologically confirmed relapsed or refractory (R/R) acute myeloid leukemia (AML) or mixed phenotype acute leukemia (MPAL) or Chronic Myelomonocytic Leukemia (CMML) or relapsed/refractory Higher-Risk MDS by 2016 WHO classification for which no available standard therapies are indicated or anticipated to result in a durable response.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights

Study Summary

This trial is testing a new combination of drugs to treat leukemia and related diseases.

Who is the study for?
This trial is for adults with Acute Myeloid Leukemia (AML) or related conditions who have not responded to previous treatments. Participants must be able to swallow tablets, not have other recent cancers except certain skin cancers and in situ carcinomas, and should not have uncontrolled illnesses or infections. They must use contraception if of childbearing potential.Check my eligibility
What is being tested?
The study tests APG-2575 combined with Azacitidine in patients with AML. It has two parts: dose escalation to find a safe dosage (Part I), followed by dose expansion to test the effectiveness at that dosage (Part II).See study design
What are the potential side effects?
Potential side effects may include typical reactions from cancer medications such as nausea, fatigue, blood cell count changes leading to increased infection risk, liver enzyme alterations, and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My leukemia involves more than one type of blood cell.
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My leukemia has returned or didn't respond to treatment, and standard therapies are not expected to work.
Select...
My MDS did not improve after 4 cycles of HMA therapy or it got worse after initially responding to HMA.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 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
DLT

Trial Design

1Treatment groups
Experimental Treatment
Group I: APG2575 + AzacitidineExperimental Treatment1 Intervention
200 mg APG2575 dose ramp up +AZA

Find a Location

Who is running the clinical trial?

Ascentage Pharma Group Inc.Lead Sponsor
46 Previous Clinical Trials
4,310 Total Patients Enrolled
Xuemi Sun, MDPrincipal InvestigatorAscentage Pharma
1 Previous Clinical Trials
65 Total Patients Enrolled
Qian Niu, MDPrincipal InvestigatorAscentage Pharma

Media Library

APG-2575 (Bcl-2 inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04964518 — Phase 1 & 2
Acute Myeloid Leukemia Research Study Groups: APG2575 + Azacitidine
Acute Myeloid Leukemia Clinical Trial 2023: APG-2575 Highlights & Side Effects. Trial Name: NCT04964518 — Phase 1 & 2
APG-2575 (Bcl-2 inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04964518 — Phase 1 & 2

Frequently Asked Questions

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

What type of patients does APG 2575 ramp up arm typically help?

"APG 2575 ramp up arm is most often used to target malignant neoplasms. However, this same treatment can be applied to other conditions such as 20-30% blasts, neutropenia and/or thrombocytopenia, and anemia."

Answered by AI

Is it possible for me to sign up and participate in this research project?

"This ongoing clinical trial is seeking 24 leukemia patients that are aged 18 to 99. Furthermore, these individuals must have a histologically confirmed relapsed or refractory diagnosis of acute myeloid leukemia, mixed phenotype acute leukemia, Chronic Myelomonocytic Leukemia, or Higher-Risk MDS. Lastly, eligible patients should not have received standard therapies nor be expected to respond well to them."

Answered by AI

Do we have a wide geographic sample for this clinical trial?

"7 sites are running this trial. They are: MDACC in Houston, Swedish Medical Center in Seattle, MD Anderson in Charlotte, as well other locations."

Answered by AI

Is this the first time APG 2575 has been used in a clinical setting?

"APG 2575 was first used in a 2006 study at Chinese University of Hong Kong-Prince of Wales Hospital. To date, there have been 160 completed trials with APG 2575. At the moment, 179 studies are actively recruiting patients; many of these taking place in Houston, Texas."

Answered by AI

How many test subjects are included in this experiment?

"That is accurate, the clinical trial mentioned is currently open and looking for patients. According to the listing on clinicaltrials.gov, the trial was first posted on 7/30/2021 and edited most recently on 11/10/2022. They are hoping to find 24 participants total from 7 different locations."

Answered by AI

Does this treatment regimen exclude elderly patients?

"To qualify for this clinical trial, applicants must between 18-99 years old. There are 466 other trials available for patients who are underaged and 1382 additional options for seniors."

Answered by AI
~3 spots leftby Jul 2024