CLL/SLLPhase 3NCT06319456
A Study of Lisaftoclax (APG-2575) Combined With Acalabrutinib Versus Immunochemotherapy for Newly Diagnosed CLL/SLL.
A Phase 3 study testing Lisaftoclax (APG-2575), Acalabrutinib and Fludarabine in people with CLL/SLL, run by Ascentage Pharma Group Inc. at 10 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CLL/SLL
- What is being tested?
- Lisaftoclax (APG-2575), Acalabrutinib and Fludarabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 344 participants
- Where
- 10 sitesChina
- Study dates
- 7 Apr 2024to Aug 2028
- Phase
- Phase 3
- 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
None listed.
Who cannot join
- 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 minor surgery (excluding biopsy) within 14 days prior to the initiation of the study.
- 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 study, at the discretion of the investigator.
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
China10 sites, 10 recruiting
- Not yet recruiting
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, 233004
Yinghua Geng, M.D., Ph.D.
Yinghua Geng, M.D., Ph.D.
- Not yet recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410031
Yajun Li, M.D., Ph.D.
Yajun Li, M.D., Ph.D.
- Not yet recruiting
The Second Xiangya Hospital of Center South University
Changsha, Hunan, 545001
Honglin Peng, M.D., Ph.D.
Honglin Peng, M.D., Ph.D.
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080
Wenyu Li, M.D., Ph.D.
Wenyu Li, M.D., Ph.D.
- Recruiting
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, 510515
Xutao Guo, M.D., Ph.D.
Xutao Guo, M.D., Ph.D.
- Not yet recruiting
Tongji Hospital of Tongji University
Shanghai, Shanghai Municipality, 200065
Jianfei Fu, M.D., Ph.D.
Jianfei Fu, M.D., Ph.D.
- Recruiting
Hematology Hospital of the Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, 300020
Lugui Qiu, M.D., Ph.D., 022-23909272, qiulg@ihcams.ac.cn
Lugui Qiu, M.D., Ph.D.
- Not yet recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430023
Jun Fang, M.D., Ph.D.
Jun Fang, M.D., Ph.D.
- Not yet recruiting
The affiliated Hospital of Guangdong Medical University
Zhanjiang, Guangdong, 524013
Yuming Zhang, M.D., PH.D.
Yuming Zhang, M.D., PH.D.
- Recruiting
Henan Provincial Cancer Hospital
Zhengzhou, Henan, 450003
Keshu Zhou, M.D., Ph.D., 13674902391, drzhouks77@163.com
Keshu Zhou, M.D., Ph.D.
About this study
Official title: A Global Multicenter Open Label Randomized Phase III Confirmatory Study of Lisaftoclax (APG-2575) in Combination With Acalabrutinib vs Immunochemotherapy in Patients With Newly Diagnosed Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma.
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.
Read the detailed description
The patients with newly diagnosed CLL/SLL, who have met all required eligibility criteria, will be randomized to the investigational group (Lisaftoclax in combination with Acalabrutinib) or the control group (immunochemotherapy, CIT).
- Conditions
- CLL/SLL
- Being tested
- Lisaftoclax (APG-2575), Acalabrutinib, Fludarabine, Cyclophosphamide，CTX, Rituximab
- Keywords
- CLL/SLL, Lisaftoclax, APG-2575
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lisaftoclax (APG-2575)Drug
QD, oral administration, every 28 days for a dosing cycle.
AcalabrutinibDrug
BID, oral administration, every 28 days for a dosing cycle.
FludarabineDrug
Every 28 days for a treatment cycle, administration of 6 cycles.
Cyclophosphamide，CTXDrug
Every 28 days for a treatment cycle, administration of 6 cycles.
RituximabDrug
Every 28 days for a treatment cycle, administration of 6 cycles.
ChlorambucilDrug
Every 28 days for a treatment cycle, administration of 6 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Lisaftoclax (APG-2575) combined with Acalabrutinib | Experimental | Lisaftoclax (APG-2575) 600 mg daily plus acalabrutinib 100 mg twice daily for a fixed duration of treatment up to 18 cycles. Receives: Drug: Lisaftoclax (APG-2575); Drug: Acalabrutinib |
| Immunochemotherapy regimens | Active comparator | FCR:
Fludarabine: intravenously infused at 25 mg/m2 /d on Days 1 to 3 of Cycles 1-6 cyclophosphamide: intravenously infused at 250 mg/m2 /d on Days 1 - 3 of Cycles 1 - 6; rituximab: intravenously infused at 375 mg/m2 on C1D1, and at 500 mg/m2 on Day 1 of Cycles 2 - 6. F
or
R-Clb: Chlorambucil: orally administrated at 0.5 mg/kg on Days 1 and 15 of Cycles 1-6; rituximab: intravenously infused at 375 mg/m2 on C1D1, and at 500 mg/m2 on Day 1 of Cycles 2 - 6. Receives: Drug: Fludarabine; Drug: Cyclophosphamide，CTX; Drug: Rituximab; Drug: Chlorambucil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progress Free Survival (PFS)
PFS is defined as the time from randomization to disease progression(PD) or death from any cause.
Measured: Up to 1 year
Secondary outcomes (3)
Objective Response Rate (ORR)
ORR is defined as the proportion of patients who have achieved CR, CRi or PR.
Measured: Up to 1 year
Minimal Residual Disease (MRD) negativity rate
To observe the proportion of patients with MRD negativity in bone marrow, peripheral blood, either or both.
Measured: Up to 1 year
Safety evaluation based on the adverse event concurrence
Number of treatment emergent adverse events (TEAEs) and treatment related adverse events (TRAEs) will be evaluated.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start7 Apr 2024
- Primary completionAug 2027 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CLL/SLLStudies of the same condition, open and under way.
- More trials run by Ascentage Pharma Group Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 344 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ascentage Pharma Group Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lugui Qiu, M.D., Ph.D., Principal investigator, Hematology Hospital of the Chinese Academy of Medical SciencesKeshu Zhou, M.D., Ph.D., Principal investigator, Henan Province Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06319456
- Sponsor's protocol ID
- APG2575CC301
- Status last verified
- Jul 2026
- First submitted
- 13 Mar 2024
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Global Multicenter Open Label Randomized Phase III Confirmatory Study of Lisaftoclax (APG-2575) in Combination With Acalabrutinib vs Immunochemotherapy in Patients With Newly Diagnosed Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma.
- ClinicalTrials.gov ID
- NCT06319456
- Acronym / sponsor ID
- APG2575CC301
- Conditions
- CLL/SLL
- Keywords
- CLL/SLL, Lisaftoclax, APG-2575
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 344 participants (estimated)
- Lead sponsor
- Ascentage Pharma Group Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Apr 2024 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 20 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The patients with newly diagnosed CLL/SLL, who have met all required eligibility criteria, will be randomized to the investigational group (Lisaftoclax in combination with Acalabrutinib) or the control group (immunochemotherapy, CIT).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lisaftoclax (APG-2575) combined with Acalabrutinib | Experimental | Drug: Lisaftoclax (APG-2575), Drug: AcalabrutinibLisaftoclax (APG-2575) 600 mg daily plus acalabrutinib 100 mg twice daily for a fixed duration of treatment up to 18 cycles. |
| Immunochemotherapy regimens | Active comparator | Drug: Fludarabine, Drug: Cyclophosphamide，CTX, Drug: Rituximab, Drug: ChlorambucilFCR: Fludarabine: intravenously infused at 25 mg/m2 /d on Days 1 to 3 of Cycles 1-6 cyclophosphamide: intravenously infused at 250 mg/m2 /d on Days 1 - 3 of Cycles 1 - 6; rituximab: intravenously infused at 375 mg/m2 on C1D1, and at 500 mg/m2 on Day 1 of Cycles 2 - 6. F or R-Clb: Chlorambucil: orally administrated at 0.5 mg/kg on Days 1 and 15 of Cycles 1-6; rituximab: intravenously infused at 375 mg/m2 on C1D1, and at 500 mg/m2 on Day 1 of Cycles 2 - 6. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (12 listed)
- 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 minor surgery (excluding biopsy) within 14 days prior to the initiation of the study.
- 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 study, at the discretion of the investigator.
- Patients who require warfarin or other anticoagulants or active hemorrhage occur within 2 months before study entry.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lisaftoclax (APG-2575)QD, oral administration, every 28 days for a dosing cycle. | Drug | Lisaftoclax (APG-2575) combined with Acalabrutinib |
| AcalabrutinibBID, oral administration, every 28 days for a dosing cycle. | Drug | Lisaftoclax (APG-2575) combined with Acalabrutinib |
| FludarabineEvery 28 days for a treatment cycle, administration of 6 cycles. | Drug | Immunochemotherapy regimens |
| Cyclophosphamide，CTXEvery 28 days for a treatment cycle, administration of 6 cycles. | Drug | Immunochemotherapy regimens |
| RituximabEvery 28 days for a treatment cycle, administration of 6 cycles. | Drug | Immunochemotherapy regimens |
| ChlorambucilEvery 28 days for a treatment cycle, administration of 6 cycles. | Drug | Immunochemotherapy regimens |
Primary outcome
Progress Free Survival (PFS)
Time frame: Up to 1 year
PFS is defined as the time from randomization to disease progression(PD) or death from any cause.
3 secondary outcomes
Objective Response Rate (ORR)
Time frame: Up to 1 year
Minimal Residual Disease (MRD) negativity rate
Time frame: Up to 1 year
Safety evaluation based on the adverse event concurrence
Time frame: Up to 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lugui Qiu, M.D., Ph.D. principal investigator
Hematology Hospital of the Chinese Academy of Medical Sciences
Keshu Zhou, M.D., Ph.D. principal investigator
Henan Province Cancer Hospital
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lisaftoclax (APG-2575), Acalabrutinib and Fludarabine in people with CLL/SLL, run by Ascentage Pharma Group Inc. at 10 sites 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 0 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 28 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 10 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Miguel Rosado-Cadena, MD (+1 301-532-7085, miguel.cadena@ascentage.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progress Free Survival (PFS) (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jul 2026.