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Compares treatment options for CLL/SLL
Official title A Global Study of Lisaftoclax (APG-2575) Combined With Acalabrutinib Versus Immunochemotherapy for Newly Diagnosed CLL/SLL.
ClinicalTrials.gov ID: NCT06319456
What this study is testing
What is Lisaftoclax (APG-2575)?
Lisaftoclax (APG-2575) is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for cll/sll.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a global, multicenter, randomized, open-label, Phase III confirmatory study to investigate the efficacy and safety of Lisaftoclax (APG-2575) in combination with Acalabrutinib in patients with newly diagnosed CLL/SLL.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- CLL/SLL must be diagnosed according to the IWCLL NCI-WG Guidelines (2018 edition) and meet at least one of the criteria requiring treatment.
- With a measurable disease.
- ECOG score 0-2.
- QTcF interval: ≤450ms in males, ≤470ms in females.
- Adequate bone marrow function independent of growth factor support.
You likely can't join if
- Any previous CLL specific treatment.
- Failure to fully recover adequately from prior surgical procedures at the discretion of the investigator. Patients who receive a major surgery within...
- Presence of significant cardiovascular disease within 6 months prior to study entry.
- A history of significant kidney, neurological, psychiatric, pulmonary, endocrine, metabolic, immune, cardiovascular, or liver disease, which will...
- Patients who require warfarin or other anticoagulants or active hemorrhage occur within 2 months before study entry.
- Known to have hypersensitivity to the drug ingredient or its analogues.
See the full eligibility criteria
- CLL/SLL must be diagnosed according to the IWCLL NCI-WG Guidelines (2018 edition) and meet at least one of the criteria requiring treatment.
- With a measurable disease.
- ECOG score 0-2.
- QTcF interval: ≤450ms in males, ≤470ms in females.
- Adequate bone marrow function independent of growth factor support.
- Adequate liver, kidney and coagulation function.
- Males and females of childbearing potential, and their partners voluntarily use effective contraceptive measures throughout the treatment and for at least three months after the last dose of the study drug. Male...
- Female patients of childbearing potential have negative serum pregnancy test results within 14 days prior to the first dose of the study drug.
- Patients must be able to understand and voluntarily sign an informed consent form approved by the Ethics Committee (EC) before commencing any screening or study specific procedures.
- Must be willing and able to complete research procedures and follow-up examinations.
- Any previous CLL specific treatment.
- Failure to fully recover adequately from prior surgical procedures at the discretion of the investigator. Patients who receive a major surgery within 28 days prior to the first dose of the study drug or who receive a...
- Presence of significant cardiovascular disease within 6 months prior to study entry.
- A history of significant kidney, neurological, psychiatric, pulmonary, endocrine, metabolic, immune, cardiovascular, or liver disease, which will have an adverse effect on the patient if he/she participates in the...
- Patients who require warfarin or other anticoagulants or active hemorrhage occur within 2 months before study entry.
- Known to have hypersensitivity to the drug ingredient or its analogues.
- Pregnant or lactating female patients and patients who are expected to become pregnant during the study period or within 3 months after the last dose.
- Patients who have history of other active malignant tumor other than CLL/SLL within 3 years before study entry.
- With a malabsorption syndrome or other conditions unsuitable for enteral administration.
- Other clinically significant uncontrolled symptoms.
- With primary active autoimmune disease and connective tissue disease.
- Any other circumstances or conditions that would, at the discretion of the investigator, make the patient unsuitable for the study.
The study team makes the final eligibility decision.
Where it's taking place
- Bengbu, Anhui, China
- Guangzhou, Guangdong, China
- Zhengzhou, Henan, China
- Wuhan, Hubei, China
- Tianjin, Tianjin Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bengbu, Anhui, China; Guangzhou, Guangdong, China; Zhengzhou, Henan, China; Wuhan, Hubei, China; Tianjin, Tianjin Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.