Phase 2 Leukaemia Trial, Recruiting NCT04501120 Sponsor: Ascentage Pharma Group Inc. Condition: Leukaemia
Back to Leukaemia

Phase 2 Leukaemia Trial, Recruiting

NCT04501120
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People diagnosed (according to WHO 2016 criteria) with one of the following blood or bone marrow conditions: relapsed or treatment-resistant acute myeloid leukemia (AML), mixed phenotype acute leukemia (MPAL), chronic myelomonocytic leukemia (CMML), higher-risk myelodysplastic syndrome (HR-MDS), blastic plasmacytoid dendritic cell neoplasm (BPDCN), or newly diagnosed AML where standard chemotherapy is not suitable due to age or other health conditions.
  • People with a general health/activity level rated at a certain score on a standard medical scale (ECOG 0–2, or 0–3 for people aged 60–74 who cannot have standard chemotherapy) (confirm with trial site).
  • People who are able to swallow and take the study drug (Lisaftoclax/APG-2575) by mouth.
  • People with a life expectancy of at least 3 months.
  • People whose kidneys and liver are functioning at an adequate level.
  • People of childbearing potential, along with their partners, who are willing to use effective contraception during the treatment period and for at least three months after the last dose of the study drug; postmenopausal women must have been without a period for at least 12 months.
  • People who are able to understand the study and are willing to sign a written consent form before any study procedures begin.
  • People who are willing and able to follow all study procedures and attend follow-up appointments.

Who may not be able to join:

  • People diagnosed with acute promyelocytic leukemia, or a specific type of AML involving a particular genetic change known as BCR-ABL1 positive (confirm with trial site).
  • People who still have side effects from previous chemotherapy or radiation therapy that remain above a certain level of severity (grade 2 or higher on a standard medical scale), not including hair loss.
  • People with known leukemia that has spread to the brain or spinal fluid.
  • People with active, symptomatic fungal, bacterial, or viral infections.
  • People who have previously had a donor stem cell transplant or certain immune cell therapies, or who have had their own stem cells transplanted within the past 12 months.
  • People who received chemotherapy (other than a specific drug called hydroxyurea, if stopped more than 24 hours before the first dose), radiation, surgery, immunotherapy, targeted therapy, biological therapy, or another experimental treatment within 14 days before starting the study drug.
  • People who took certain medications that strongly affect how the body processes drugs (strong or moderate CYP3A inducers or inhibitors) within 7 days before starting the study drug (confirm with trial site).
  • People with stomach or bowel conditions that the treating doctor believes would affect how the body absorbs the study drug.
  • People who, in the treating doctor's judgement, have any other condition that would make participation in the trial unsuitable.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Yifan Zhai, M.D., Ph.D., Suzhou Yasheng Pharmaceutical Co., Ltd.

Phone: +86 571-87236896

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Ascentage Pharma Group Inc.
Registry
ClinicalTrials.gov
Start date
28 September 2020
Est. completion
1 September 2028

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Dose Limiting Toxicities (DLT); Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose(RP2D)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov