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NCT06104566
Global Trial in APG2575 for Patients With CLL/SLL
Phase 3 trial testing lisaftoclax +BTK inhibitor in CLL/SLL in 400 participants. Currently enrolling.
20 October 2025
Quick facts
| Lead sponsor | Ascentage Pharma Group Inc. |
|---|---|
| Phase | Phase 3 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 400 |
| Start date | 20 December 2023 |
| Primary completion | 20 October 2025 |
| Estimated completion | 31 October 2027 |
| Sites | 2 locations across Russia, United States |
Drugs / interventions tested
- lisaftoclax +BTK inhibitor — full drug profile →
- BTK inhibitor — full drug profile →
Conditions studied
- CLL/SLL — all drugs for CLL/SLL →
Sponsor
Ascentage Pharma Group Inc. — full company profile →
Who can join
Adults 18 to 99, any sex, with CLL/SLL. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a global multicenter, open label, randomized, registrational phase III study to investigate the efficacy and safety of lisaftoclax in combination with BTK inhibitors in CLL/SLL patients who previously treated with BTK inhibitors
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
The BCL2 family: from apoptosis mechanisms to new advances in targeted therapy.
Vogler M, Braun Y, Smith VM, Westhoff MA, et al · · 2025 · cited 104× · PMID 40113751 · DOI 10.1038/s41392-025-02176-0 -
PI3K Inhibitors in Hematology: When One Door Closes….
Skånland SS, Okkenhaug K, Davids MS. · · 2024 · cited 19× · PMID 38967552 · DOI 10.1158/1078-0432.ccr-24-0967 -
Ibrutinib and venetoclax in combination for chronic lymphocytic leukemia: synergy in practice.
Timofeeva N, Jain N, Gandhi V. · · 2024 · cited 6× · PMID 39949788 · DOI 10.1016/j.bneo.2024.100034 -
The Development of Novel Therapies for Chronic Lymphocytic Leukaemia in the Era of Targeted Drugs.
Robak T, Iskierka-Jażdżewska E, Puła A, Robak P, et al · · 2025 · cited 1× · PMID 41303291 · DOI 10.3390/jcm14228247
Verify or expand the search:
- PubMed search for NCT06104566
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for CLL/SLL
Currently open trials in the same condition.
- NCT07108998 — Study of Epcoritamab as a Consolidation Therapy in CLL/SLL · Phase 2 · recruiting
- NCT06978088 — LP-168 and Obinutuzumab for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) and Variants of This · Phase 2 · recruiting
- NCT06508684 — Current Status of BTKi Treatment for CLL/SLL in China · recruiting
- NCT05590702 — French Observational Study of Patients With Chronic Lymphocytic Leukemia Or Small Lymphocytic Lymphoma in Real-World Set · active not recruiting
- NCT04775745 — Study of Oral Administration of LP-168 in Patients With Relapsed or Refractory B-cell Malignancies. · Phase 1 · recruiting
Other Ascentage Pharma Group Inc. trials
Trials by the same sponsor.
- NCT07282093 — Pharmacokinetics of Olverembatinib in Participants With Hepatic Impairment · Phase 1 · recruiting
- NCT06640361 — A Study of Olverembatinib in SDH-deficient GIST. · Phase 3 · recruiting
- NCT06389292 — A Pivotal Study of APG-2575 (Lisaftoclax) Combined With Azacitidine in the Treatment of Acute Myeloid Leukemia · Phase 3 · recruiting
- NCT06051409 — A Study of Olverembatinib in Patients With Newly Diagnosed Ph+ALL. · Phase 3 · recruiting
- NCT05773586 — A Study to Evaluate the Safety, Pharmacokinetics and Preliminary Efficacy of APG-5918. · Phase 1 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06104566 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Ascentage Pharma Group Inc.
- Last refreshed: 18 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06104566.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing