Phase 2 Lymphoma Trial, Recruiting NCT04494503 Sponsor: Ascentage Pharma Group Inc. Condition: Lymphoma
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Phase 2 Lymphoma Trial, Recruiting

NCT04494503
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 aged 18 years or older
  • People who have been diagnosed with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that has come back or stopped responding to previous treatment, according to specific medical guidelines
  • People whose cancer has spread to lymph nodes 10 cm or larger in size may need special approval from the trial sponsor before being considered (confirm with trial site)
  • People whose general physical functioning is rated as 0 or 1 on a standard medical scale, meaning they are fully active or have only minor restrictions on physically strenuous activity
  • People whose heart electrical activity (measured by a specific heart test called an ECG) falls within an acceptable range for their sex
  • People whose bone marrow, kidneys, and liver are functioning well enough without the need for special support treatments
  • People who are willing to use effective contraception throughout the treatment period and for at least three months after the last dose
  • Women who could become pregnant must have a negative pregnancy test within 14 days before starting the trial drug
  • Male participants must agree not to donate sperm during treatment and for at least three months after the last dose
  • People who are able to understand and sign a written consent form before any trial procedures begin
  • People who are willing and able to follow all trial procedures and attend follow-up appointments

Who may not be able to join:

  • People who have had a donor stem cell transplant at any time, a cell-based immune therapy within the past 24 months, or their own stem cells transplanted back within the past 12 months
  • People who have received a specific type of antibody therapy targeting CLL within 4 weeks before the first trial dose
  • People who have received anti-cancer treatments (such as chemotherapy, radiation, steroids for cancer, certain herbal cancer medicines, or investigational drugs) within 14 days or a set number of half-lives of those drugs before the first dose, or who still have significant side effects from previous treatments that have not sufficiently resolved
  • People who have taken certain medications that affect how the body processes drugs (specific CYP3A inhibitors or inducers, such as fluconazole, ketoconazole, clarithromycin, rifampin, carbamazepine, phenytoin, or St. John's wort) within 14 days before the first dose
  • People who have not sufficiently recovered from a surgical procedure, or who have had major surgery within 28 days or minor surgery within 14 days before starting the trial
  • People who have previously been treated with a type of drug called a Bcl-2 inhibitor
  • People whose CLL/SLL has transformed into a more aggressive lymphoma or has spread to the brain or spinal cord
  • People with moderate or severe heart disease (Grade 2 or higher by a standard heart classification system)
  • People with a significant history of serious kidney, nerve, psychiatric, lung, hormonal, immune, heart, or liver disease that the trial doctor believes could be made worse by participating
  • People who require blood-thinning medications such as warfarin or similar anticoagulants
  • People who are known to be allergic to the trial drug or similar substances
  • People who are pregnant, breastfeeding, or planning to become pregnant during the trial or within 3 months after the last dose
  • People who have had another active cancer (other than CLL/SLL) within the 3 years before joining, with some exceptions such as fully treated early-stage cervical cancer, completely removed skin cancers, or previously cured cancers that have been fully treated
  • People who have a condition that prevents them from properly absorbing oral medications
  • People with uncontrolled serious infections (including certain hepatitis B, hepatitis C, or HIV infections) or who have had a fever with very low white blood cell counts within the week before starting the trial
  • People with active and uncontrolled autoimmune conditions affecting blood cells, such as autoimmune hemolytic anemia or immune thrombocytopenia
  • People who have any other condition that the trial doctor believes would make participation 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 15 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., yzhai@ascentage.com

Phone: +86-25-83781120

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
31 August 2020
Est. completion
20 October 2024

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Adverse events of APG-2575 single agent; Objective Response Rate (ORR) of APG-2575 single agent; Dose Limiting Toxicities (DLT) of combination therapy; 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: 15 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