Phase 2 Leukaemia Trial, Recruiting NCT04496349 Sponsor: Ascentage Pharma Group Inc. Condition: Leukaemia
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Phase 2 Leukaemia Trial, Recruiting

NCT04496349
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 who are 18 years of age or older
  • People who have been diagnosed with T-cell prolymphocytic leukemia (T-PLL) that has come back or stopped responding to treatment, still has signs of active disease, and who have already received at least one prior treatment
  • People who have been diagnosed with a type of blood cancer called non-Hodgkin lymphoma (NHL) that has come back, stopped responding to treatment, or where other treatments that might help are not suitable or cannot be tolerated
  • People who have not received chemotherapy or antibody-based treatment for at least 7 days before starting the trial drugs (people with fast-growing disease may have received certain specific medications up to 24 hours before starting, confirm with trial site)
  • People whose blood counts meet certain minimum levels — specifically, a neutrophil count of at least 500/mm³, hemoglobin of at least 60 g/L, and platelet count of at least 30,000/mm³
  • People whose liver, kidneys, and other organs are functioning well enough to safely take part (confirm specific requirements with trial site)
  • People whose general physical condition is rated 0, 1, or 2 on a standard medical scale, meaning they are able to carry out at least some daily activities (confirm with trial site)
  • People who are able to understand what the study involves and who have signed a consent form agreeing to take part (a legal representative may sign on behalf of the patient if needed)

Who may not be able to join:

  • People who have previously been treated with a type of drug called an MDM2 inhibitor
  • People who have active, uncontrolled cancer that has spread to the brain or spinal cord
  • People who currently need treatment to manage graft-versus-host disease, or who have taken certain immune-suppressing medications called calcineurin inhibitors within the past 4 weeks
  • People who have other health conditions or illnesses that, in the opinion of the medical team running the trial, could put them at risk or affect the reliability of the trial results
  • People who have taken certain medications that strongly affect how the body processes drugs (specifically strong CYP2C8 inhibitors, or moderate or strong CYP3A4 inhibitors or inducers) within 14 days or 7 half-lives before starting the trial, whichever period is longer (confirm with trial site which medications apply)

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, MD, PhD, Ascentage Pharma Group Inc.

Phone: 301-802-3659

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
12 July 2021
Est. completion
31 May 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Maximum tolerated dose of APG-115; Maximum tolerated dose of APG-115+APG-2575

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