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Indolent LymphomaPhase 2NCT07459608

Efficacy and Safety of Lisaftoclax (APG-2575) Monotherapy in Patients With Mature B-cell Lymphoma

A Phase 2 study testing Lisaftoclax in people with Indolent Lymphoma and WM, run by Henan Cancer Hospital at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This is a multicenter, prospective, single-arm phase II study designed to evaluate the safety and efficacy of lisaftoclax (APG-2575), an oral selective BCL-2 inhibitor, in patients with indolent B-cell lymphomas. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Indolent Lymphoma, WM, MZL
What is being tested?
Lisaftoclax
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
1 siteChina
Study dates
10 Jul 2026to 1 Mar 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years at the time of signing the informed consent form (ICF).
  • Histologically confirmed diagnosis of an indolent lymphoma (CLL/WM/MZL), meeting one of the following conditions:
  • Cohort A: Previously untreated and ineligible for Bruton's Tyrosine Kinase inhibitor (BTKi) therapy due to severe comorbidities (e.g., uncontrolled hypertension, cardiac disease, or active infection, etc.).
  • Cohort B: Received only one prior line of BTKi as first-line treatment, did not achieve a partial response (PR), and discontinued BTKi due to intolerable treatment-related adverse events (e.g., atrial fibrillation, hemorrhage, infection, rash, etc.).
  • Adequate bone marrow function, defined as:
  • Hemoglobin (Hb) ≥ 70 g/L (without transfusion support within 7 days prior to the first dose of study drug).
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  • Absolute neutrophil count (ANC) ≥ 0.5 × 10⁹/L (independent of growth factor support within 7 days prior to the first dose of study drug).
  • Platelet count ≥ 50 × 10⁹/L (without transfusion support within 7 days prior to the first dose of the study drug. If the patient has documented bone marrow involvement, a platelet count ≥ 30 × 10⁹/L is acceptable, provided the investigator ensures adequate supportive care).
  • Adequate hepatic and renal function, defined as:
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN).
  • Creatinine clearance (Ccr) ≥ 40 ml/min (estimated by the Cockcroft-Gault formula).
  • Total bilirubin < 1.5 × ULN.
  • Left ventricular ejection fraction (LVEF) ≥ the lower limit of normal (LLN, 50%).
  • Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 3.
  • Life expectancy ≥ 3 months.
  • Men, women of childbearing potential (WOCBP, defined as premenopausal women capable of becoming pregnant), and their partners must agree to use highly effective contraception methods (e.g., condoms, implants/injections/oral contraceptives, intrauterine devices [IUD], abstinence, or a sterilized partner) during the treatment period and for 90 days after the last dose of the study drug. Postmenopausal women (at least 12 months of spontaneous amenorrhea) or surgically sterile women are not considered WOCBP.

Who cannot join

  • Prior treatment with any B-cell lymphoma 2 (BCL-2) inhibitor.
  • Patients with active infection (including active hepatitis B virus [HBV] or hepatitis C virus [HCV] infection, or human immunodeficiency virus [HIV] positivity) or any other serious uncontrolled medical condition (Patients who are hepatitis B surface antigen (HBsAg) positive or hepatitis B core antibody (HBcAb) seropositive are eligible if their HBV DNA is below the lower limit of detection/quantification and they are willing to undergo monthly HBV reactivation monitoring. Patients who are HCV antibody positive are eligible if their HCV RNA is below the lower limit of detection/quantification).
  • Presence of other concurrent malignancies (except for those specified in the inclusion criteria) that may affect the interpretation of study results or treatment with the investigational drug, or patients with severe coagulation disorders, or severe impairment of cardiac, cerebral, pulmonary, hepatic, or renal function.
  • History of deep vein thrombosis (DVT) or pulmonary embolism (PE) within 12 months prior to the first dose of the study drug.
  • Administration of any live vaccine within 28 days prior to the first dose of the study drug.
  • Women of childbearing potential (WOCBP) or men with partners of childbearing potential who are unwilling to use highly effective contraception; pregnant or breastfeeding women.
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  • Inability to swallow tablets, or presence of malabsorption syndrome, any disease significantly affecting gastrointestinal function, gastrectomy/small bowel resection, symptomatic inflammatory bowel disease or ulcerative colitis, or partial/complete bowel obstruction.
  • Known hypersensitivity to the active pharmaceutical ingredient, excipients of the study drug, or its analogs.
  • Requirement for concomitant treatment with strong inhibitors or inducers of cytochrome P450 (CYP) 3A.
  • Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's judgment, could compromise the patient's safety or pose an undue risk for study participation.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Keshu Zhou, M.D contact

13674902391

dr_zkshu23810@163.com

China1 site

  • Henan cancer hospital

    Zhengzhou, Henan

Other trials in China

About this study

Official title: Efficacy and Safety of Lisaftoclax (APG-2575) Monotherapy in Patients With Mature B-cell Lymphomas

This is a multicenter, prospective, single-arm phase II study designed to evaluate the safety and efficacy of lisaftoclax (APG-2575), an oral selective BCL-2 inhibitor, in patients with indolent B-cell lymphomas. The study will enroll adult patients with chronic lymphocytic leukemia (CLL), Waldenström macroglobulinemia (WM), or marginal zone lymphoma (MZL) who are either treatment-naïve but considered ineligible for Bruton tyrosine kinase (BTK) inhibitor therapy due to significant comorbidities, or who are intolerant to prior BTK inhibitor treatment.

Eligible patients will receive oral lisaftoclax once daily with a dose ramp-up to a target dose of 600 mg in 28-day cycles. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or completion of the planned treatment period. The primary objective is to evaluate the safety and tolerability of lisaftoclax monotherapy, while secondary objectives include assessment of antitumor activity, including overall response rate (ORR), complete response (CR) rate, minimal residual disease (MRD) negativity, progression-free survival (PFS), duration of response (DOR), and overall survival (OS). Quality of life will also be assessed using the EORTC QLQ-C30 questionnaire.

Being tested
Lisaftoclax

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LisaftoclaxDrug

    Also called APG2575

    Continuous Monotherapy

Study groups in NCT07459608
Study groupRoleWhat they receive
Lisaftoclax MonotherapyExperimentalPatients with histologically confirmed indolent B-cell lymphomas (CLL, WM, or MZL,MCL) who are either treatment-naïve but considered ineligible for Bruton tyrosine kinase (BTK) inhibitor therapy due to significant comorbidities, or who are intolerant to prior BTK inhibitor therapy, will receive lisaftoclax monotherapy. Lisaftoclax will be administered orally once daily with a dose ramp-up schedule to a target dose of 600 mg. Treatment will be given in 28-day cycles and continued until disease progression, unacceptable toxicity, withdrawal of consent, or investigator decision.
Receives: Drug: Lisaftoclax

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. safety and tolerance

    events (AEs) and serious adverse events (SAEs), graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.

    Measured: From the first dose to within 30 days after the last dose.

Secondary outcomes (6)

  1. Overall Response Rate (ORR)

    The proportion of patients achieving complete response (CR) or partial response (PR) according to disease-specific response criteria (IWCLL 2018 for CLL, IWWM-6 for WM, and Lugano 2014 criteria for MZL).

    Measured: Up to 24 months

  2. Complete Response Rate (CR)

    The proportion of patients achieving complete response according to disease-specific response criteria.

    Measured: Up to 24 months

  3. Minimal Residual Disease (MRD) Negativity Rate

    The proportion of patients achieving minimal residual disease negativity assessed by flow cytometry.

    Measured: Up to 24 months

  4. Progression-Free Survival (PFS)

    Time from first dose of study treatment to disease progression or death from any cause.

    Measured: Up to 24 months

  5. Duration of Response (DOR)

    Time from first documented response (CR or PR) to disease progression or death.

    Measured: Up to 24 months

  6. Overall Survival (OS)

    Time from first dose of study treatment to death from any cause.

    Measured: Up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2026
  2. Study start10 Jul 2026 (estimated)
  3. Primary completion1 Jul 2027 (estimated)
  4. Study completion1 Mar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07459608
Sponsor's protocol ID
Lisa-2025-777
Status last verified
Jul 2026
First submitted
5 Mar 2026
Last updated
29 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lisaftoclax in people with Indolent Lymphoma and WM, run by Henan Cancer Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Keshu Zhou, M.D (13674902391, dr_zkshu23810@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

safety and tolerance (time frame: From the first dose to within 30 days after the last dose.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07459608.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.

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