Lacutoclax for Relapsed or Refractory CLL/SLL

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase II, open-label, single-arm study evaluating the efficacy and safety of an oral BCL-2 inhibitor, Lacutoclax, in patients with relapsed or refractory CLL/SLL. Eligible participants have measurable disease and adequate organ function, and must have recovered from prior therapies to at least Grade 1 toxicity. The trial is conducted at multiple centers with a designated sponsor and uses standard iwCLL criteria for diagnosis and response assessment. Outcomes focus on antisense efficacy signals and safety in a population with limited remaining options.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients with confirmed R/R CLL/SLL according to the 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria.
2. Patients who had previously received standard therapy, experienced disease progression following the most recent line of treatment (excluding intolerance), and had at least one indication for treatment prior to enrollment.
3. Have at least one measurable lesion.
4. Age ≥18 years, regardless of sex.
5. Eastern Cooperative Oncology Group (ECOG) performance status score ≤2.
6. Life expectancy ≥ 12 weeks.
7. Adequate coagulation function, liver and kidney function, bone marrow hematopoietic function.
8. Toxicities from prior anti-tumor therapy have recovered to Grade ≤1 according to NCI CTCAE v5.0.
9. Male patients and female patients of childbearing potential must agree to use effective contraception during the study and for 90 days after the last dose of Lacutoclax. Female patients of childbearing potential must have a negative pregnancy test before study treatment and must not be breastfeeding. Male patients must not donate sperm during the study and for 90 days after the last dose of Lacutoclax.
10. Participation is voluntary, requiring signed informed consent and compliance with the treatment regimen and visit schedule.

Exclusion Criteria:

1. Known hypersensitivity to Lacutoclax or any of its excipients.
2. Prior treatment with a BCL-2 family inhibitor.
3. History of or currently suspected Richter's syndrome.
4. Known or suspected central nervous system (CNS) involvement.
5. Prior allogeneic hematopoietic stem cell transplantation (allo-HSCT), or autologous hematopoietic stem cell transplantation (auto-HSCT) or chimeric antigen receptor T-cell (CAR-T) therapy within 90 days before the first dose of study treatment.
6. Received antitumor therapy, investigational agents, major surgery, severe trauma, or live attenuated vaccines within 4 weeks or 5 half-lives prior to the first dose of study treatment.
7. Received corticosteroids for antitumor purposes, herbal medicines for antitumor treatment, or localized radiotherapy within 14 days prior to the first dose of study treatment.
8. Use of moderate or strong CYP3A inhibitors within 7 days prior to the first dose of study treatment, or consumption of grapefruit, grapefruit juice, starfruit, or Seville oranges within 3 days prior to dosing.
9. Prior malignancy other than CLL/SLL within the past 2 years, except for curatively treated basal cell carcinoma, localized squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast, or other malignancies considered cured.
10. Major cardiovascular or cerebrovascular events within 6 months prior to the first dose of study treatment.
11. Presence of any severe and/or uncontrolled systemic disease.
12. Impaired cardiac function.
13. Any uncontrolled systemic infection.
14. Conditions that may impair oral drug administration or significantly affect absorption or pharmacokinetics of the study drug.
15. Unable to discontinue moderate or strong CYP3A inhibitors or inducers, or sensitive CYP2C8 substrates during the study period.
16. Primary autoimmune disease requiring immunosuppressive therapy.
17. Any other condition that, in the investigator's judgment, makes the patient unsuitable for study participation.

Where it's running

• The First Affiliated Hospital of Nanjing Medical University
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Jianyong Li
• Email: lijianyonglm@126.com
• Phone: 025-83781120

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.