A Study of Lisaftoclax (APG-2575) Combined With Acalabrutinib Versus Immunochemotherapy for Newly Diagnosed CLL/SLL.

Recruiting Phase 3 Interventional Study
CLL/SLL
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
344 (estimated)
Sponsor
Ascentage Pharma Group Inc. · Industry
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About This Trial

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.

Trial Locations
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Eligibility Criteria
1. CLL/SLL must be diagnosed according to the IWCLL NCI-WG Guidelines (2018 edition) and meet at least one of the criteria requiring treatment. 2. With a measurable disease. 3. ECOG score 0-2. 4. QTcF interval: ≤450ms in males, ≤470ms in females. 5. Adequate bone marrow function independent of growt…
Contacts

Miguel Rosado-Cadena, MD

+1 301-532-7085

miguel.cadena@ascentage.com

CONTACT

Jocelyn Budzynski

+1 301-693-6952

jocelyn.budzynski@ascentage.com

CONTACT