Ignite Creation Date:
2025-12-24 @ 4:42 PM
Ignite Modification Date:
2026-01-04 @ 5:06 PM
Study NCT ID:
NCT06104566
Status:
RECRUITING
Last Update Posted:
2025-09-18
First Post:
2023-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Global Trial in APG2575 for Patients With CLL/SLL
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '1:1 ratio to investigational arm (lisaftoclax in combination with BTKi ) or the control arm (BTKi).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-12-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-15', 'studyFirstSubmitDate': '2023-10-23', 'studyFirstSubmitQcDate': '2023-10-26', 'lastUpdatePostDateStruct': {'date': '2025-09-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-10-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PFS', 'timeFrame': '12 months', 'description': 'To evaluate the progression-free survival (PFS) of lisaftoclax in combination with BTKi compared with BTKi monotherapy in CLL/SLL patients previously treated with BTKi as determined by independent radiological review committee (IRC) using the iwCLL guidelines'}], 'secondaryOutcomes': [{'measure': 'overall survival', 'timeFrame': '12 months', 'description': 'To evaluate overall survival (OS) of lisaftoclax in combination with BTKi versus BTKi'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['CLL/SLL']}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': 'Approximately 440 patients will be enrolled, the patients who meet the eligibility criteria will be randomized in a 1:1 ratio to investigational arm (lisaftoclax in combination with a BTK inhibitor) or the control arm (BTK inhibitor alone). These patients with CLL/SLL have been on BTKi monotherapy and meet all other protocol required eligibility criteria.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. \\- Age ≥ 18 years.\n2. . 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\n3. ECOG Performance Status grade 0-2\n4. Adequate bone marrow function independent of growth factor or transfusion support within 2 weeks of screening initiation as follows:\n\n * Absolute neutrophil count ≥ 1.0 × 109/L\n * Platelet counts ≥ 75 × 109/L; in cases of thrombocytopenia\n * Total hemoglobin ≥ 9 g/dL,\n5. Adequate renal function\n\n * 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.\n * 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.\n6. Adequate liver function as indicated by:\n\n * Total bilirubin ≤ 1.5 x ULN, except patients with known Gilbert's Syndrome\n * Aspartate aminotransferase (AST) ≤ 2.5 x the institutional ULN value\n * Alanine aminotransferase (ALT) ≤ 2.5 x the institutional ULN value,\n * International normalized Ratio (INR), Prothrombin Time (PT) or Activated Partial Thromboplastin time (APTT) ≤ 1.5×ULN.\n7. Ability and willingness to provide written informed consent and to adhere to the study visit schedule and other protocol requirements"}, 'identificationModule': {'nctId': 'NCT06104566', 'briefTitle': 'Global Trial in APG2575 for Patients With CLL/SLL', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ascentage Pharma Group Inc.'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': 'APG2575CG301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 1', 'description': 'Combination therapy', 'interventionNames': ['Drug: lisaftoclax +BTK inhibitor']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 2', 'description': 'mono therapy', 'interventionNames': ['Drug: BTK inhibitor']}], 'interventions': [{'name': 'lisaftoclax +BTK inhibitor', 'type': 'DRUG', 'description': 'lisaftolax + BTK inhibitor', 'armGroupLabels': ['Arm 1']}, {'name': 'BTK inhibitor', 'type': 'DRUG', 'description': 'BTK inhibitor', 'armGroupLabels': ['Arm 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Nitin Jain, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '246007', 'city': 'Kaluga', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Elena Borisenkova, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kaluga Regional Clinical Research', 'geoPoint': {'lat': 54.53063, 'lon': 36.27}}], 'centralContacts': [{'name': 'Laura Glass', 'role': 'CONTACT', 'email': 'laura.glass@ascentage.com', 'phone': '301-520-5964'}, {'name': 'Yifan Zhai, MD', 'role': 'CONTACT', 'email': 'yzhai@ascentage.com', 'phone': '301-549-6188'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ascentage Pharma Group Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}