RECRUITING

Global Trial in APG2575 for Patients With CLL/SLL

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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

Official Title

A Global Multicenter, Open Label, Randomized Phase 3 Registrational Study of Lisaftoclax (APG-2575) in Previously Treated Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (GLORA Study)

Quick Facts

Study Start:2023-12-20

Study Completion:2027-10-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06104566

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 99 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. \- Age ≥ 18 years. 2. . Patients that have documented CLL/SLL who meet iwCLL 2018 criteria for CLL treatment guidelines are eligible for treatment and must be receiving BTKi monotherapy for at least 12 months 3. ECOG Performance Status grade 0-2 4. Adequate bone marrow function independent of growth factor or transfusion support within 2 weeks of screening initiation as follows: * Absolute neutrophil count ≥ 1.0 × 109/L * Platelet counts ≥ 75 × 109/L; in cases of thrombocytopenia * Total hemoglobin ≥ 9 g/dL, 5. Adequate renal function * Creatinine clearance must be \> 50 ml/min directly measured with 24hr urine collection or calculated according to the modified formula of Cockcroft and Gault (for men: GFR ≈ ((140 - age) x actual body weight)/(72 x creatinine), for women x 0.85) or an equally accurate method. * For patients with creatinine values within the normal range, the calculation of clearance is not necessary. Dehydrated patients with an estimated creatinine clearance less than 50 ml/min may be eligible if a repeat estimate after adequate hydration is \> 50 ml/min. 6. Adequate liver function as indicated by: * Total bilirubin ≤ 1.5 x ULN, except patients with known Gilbert's Syndrome * Aspartate aminotransferase (AST) ≤ 2.5 x the institutional ULN value * Alanine aminotransferase (ALT) ≤ 2.5 x the institutional ULN value, * International normalized Ratio (INR), Prothrombin Time (PT) or Activated Partial Thromboplastin time (APTT) ≤ 1.5×ULN. 7. Ability and willingness to provide written informed consent and to adhere to the study visit schedule and other protocol requirements	Pregnancy or breastfeeding Severe psychiatric disorders Active substance abuse Unstable medical conditions Inability to comply with study requirements

Inclusion Criteria

Exclusion Criteria

1. \- Age ≥ 18 years.
2. . Patients that have documented CLL/SLL who meet iwCLL 2018 criteria for CLL treatment guidelines are eligible for treatment and must be receiving BTKi monotherapy for at least 12 months
3. ECOG Performance Status grade 0-2
4. Adequate bone marrow function independent of growth factor or transfusion support within 2 weeks of screening initiation as follows:
* Absolute neutrophil count ≥ 1.0 × 109/L
* Platelet counts ≥ 75 × 109/L; in cases of thrombocytopenia
* Total hemoglobin ≥ 9 g/dL,
5. Adequate renal function
* Creatinine clearance must be \> 50 ml/min directly measured with 24hr urine collection or calculated according to the modified formula of Cockcroft and Gault (for men: GFR ≈ ((140 - age) x actual body weight)/(72 x creatinine), for women x 0.85) or an equally accurate method.
* For patients with creatinine values within the normal range, the calculation of clearance is not necessary. Dehydrated patients with an estimated creatinine clearance less than 50 ml/min may be eligible if a repeat estimate after adequate hydration is \> 50 ml/min.
6. Adequate liver function as indicated by:
* Total bilirubin ≤ 1.5 x ULN, except patients with known Gilbert's Syndrome
* Aspartate aminotransferase (AST) ≤ 2.5 x the institutional ULN value
* Alanine aminotransferase (ALT) ≤ 2.5 x the institutional ULN value,
* International normalized Ratio (INR), Prothrombin Time (PT) or Activated Partial Thromboplastin time (APTT) ≤ 1.5×ULN.
7. Ability and willingness to provide written informed consent and to adhere to the study visit schedule and other protocol requirements

Pregnancy or breastfeeding
Severe psychiatric disorders
Active substance abuse
Unstable medical conditions
Inability to comply with study requirements

Contacts and Locations

Study Contact

Laura Glass

CONTACT

301-520-5964

laura.glass@ascentage.com

Yifan Zhai, MD

CONTACT

301-549-6188

yzhai@ascentage.com

Study Locations (Sites)

MD Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: Ascentage Pharma Group Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-20

Study Completion Date2027-10-31

Study Record Updates

Study Start Date2023-12-20

Study Completion Date2027-10-31

Terms related to this study

Additional Relevant MeSH Terms

CLL/SLL