A Global Multicenter, Open Label, Randomized Phase III Confirmatory Study of Lisaftoclax (APG-2575) in Combination with Acalabrutinib versus Immunochemotherapy in Patients with Newly Diagnosed Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (GLORA-2 Study)

Conditions

Newly Diagnosed Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Brief summary

IRC-assessed PFS: The time from randomization to PD or death from any cause, whichever occurs first.

Detailed description

Key secondary endpoint: Investigator-assessed PFS: The time from randomization to PD or death from any cause, whichever occurs first., Other secondary endpoints: OS: The time from randomization to death., IRC- and investigator-assessed ORR: ORR includes complete response (CR), complete response with incomplete bone marrow recovery (CRi) or partial response (PR). CLL responsewill be assessed according to IWCLL NCI-WG guidelines (2018 Edition), and SLL response will be assessed according to Lugano 2014 criteria for response assessment in lymphoma., IRC- and investigator-assessed TTR: The interval from randomization to the date of the first confirmed CR, CRi, or PR., IRC- and investigator-assessed DOR: The interval from the date of first confirmed CR, CRi or PR to PD, or the start of a new anti-tumor treatment, or death, whichever occurs first., MRD negativity rate: Proportion of patients with MRD-negative result in bone marrow, peripheral blood, either or both., Safety and tolerability of patients: Treatment emergent adverse events (TEAEs) and treatment related adverse events (TRAEs) will be evaluated., Concentration data of Lisaftoclax and critical parameters of population pharmacokinetics.

Related papers

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Papers published before 2008-02-04 may not appear yet. Historical indexing is in progress.

Interventions

DRUGACALABRUTINIB

DRUGLisaftoclax

DRUGRITUXIMAB

DRUGFLUDARABINE PHOSPHATE

DRUGCYCLOPHOSPHAMIDE MONOHYDRATE

DRUGCHLORAMBUCIL

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
IRC-assessed PFS: The time from randomization to PD or death from any cause, whichever occurs first.	—

Secondary

Measure	Time frame
Key secondary endpoint: Investigator-assessed PFS: The time from randomization to PD or death from any cause, whichever occurs first., Other secondary endpoints: OS: The time from randomization to death., IRC- and investigator-assessed ORR: ORR includes complete response (CR), complete response with incomplete bone marrow recovery (CRi) or partial response (PR). CLL responsewill be assessed according to IWCLL NCI-WG guidelines (2018 Edition), and SLL response will be assessed according to Lugano 2014 criteria for response assessment in lymphoma., IRC- and investigator-assessed TTR: The interval from randomization to the date of the first confirmed CR, CRi, or PR., IRC- and investigator-assessed DOR: The interval from the date of first confirmed CR, CRi or PR to PD, or the start of a new anti-tumor treatment, or death, whichever occurs first., MRD negativity rate: Proportion of patients with MRD-negative result in bone marrow, peripheral blood, either or both., Safety and tolerability o	—

Measure

Time frame

Key secondary endpoint: Investigator-assessed PFS: The time from randomization to PD or death from any cause, whichever occurs first., Other secondary endpoints: OS: The time from randomization to death., IRC- and investigator-assessed ORR: ORR includes complete response (CR), complete response with incomplete bone marrow recovery (CRi) or partial response (PR). CLL responsewill be assessed according to IWCLL NCI-WG guidelines (2018 Edition), and SLL response will be assessed according to Lugano 2014 criteria for response assessment in lymphoma., IRC- and investigator-assessed TTR: The interval from randomization to the date of the first confirmed CR, CRi, or PR., IRC- and investigator-assessed DOR: The interval from the date of first confirmed CR, CRi or PR to PD, or the start of a new anti-tumor treatment, or death, whichever occurs first., MRD negativity rate: Proportion of patients with MRD-negative result in bone marrow, peripheral blood, either or both., Safety and tolerability o

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Countries

Bulgaria, Czechia, Spain

Outcome results

None listed