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A Worldwide Study Testing the New Drug Lisaftoclax for Patients with Newly Diagnosed Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (GLORA-2).
EU CTIS ID: 2024-514084-26-00
What this study is testing
To evaluate the progression‑free survival (PFS) of Lisaftoclax in combination with acalabrutinib versus immunochemotherapy in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) determinated by Independent Review Committee (IRC).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥18 years
- Patients must be able to understand and voluntarily sign a written informed consentthat has been approved by the Ethics Committee (EC) before any screening or study-specific procedure
- Patients must be willing and able to complete study procedures and follow-up examinations
- Diagnosed with CLL/SLL based on IWCLL NCI-WG guidelines (2018 Edition) and indicating at least one of the criteria for treatment (see Appendix 14: Treatment Criteria).
- Measurable disease (peripheral blood lymphocyte ≥ 5 × 109/L, or enlargement of lymph nodes (baseline LDi ≥ 1.5 cm), or hepatomegaly or splenomegaly caused by CLL/SLL).
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 to 2
You likely can't join if
- Any previous CLL/SLL-specific treatments (excluding corticosteroids for necessary immediate intervention; only a maximum daily equivalent dose of prednisone less than or equal to 20 mg is allowed within 10 days before starting the study treatment).
- Known to have hypersensitivity to ingredients or analogues of drugs used in the study
- Pregnant or lactating female patients and patients who are expected to become pregnant during the study period or within 3 months after the last dose.
- Patients who have history of other active malignant tumor other than CLL/SLL within 3 years before study entry, except for: • Adequately treated carcinoma in situ of cervix uteri • Completely resected basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin • Confinement and resection of previously cured malignancies (or other treatments). Note: If patients stopped antitumor treatment for ≥3 years and there was no tumor recurrence for ≥3 years prior to joining the study, these patients could be enrolled.
- Malabsorption syndrome or other conditions not suitable for enteral administration.
- Other clinically significant uncontrolled symptoms, including but not limited to: uncontrolled active systemic infection (virus, bacteria or fungi), known clinically active hepatitis B or C, or HIV infection.
See the full eligibility criteria
Who can join
- Age ≥18 years
- Patients must be able to understand and voluntarily sign a written informed consentthat has been approved by the Ethics Committee (EC) before any screening or study-specific procedure
- Patients must be willing and able to complete study procedures and follow-up examinations
- Diagnosed with CLL/SLL based on IWCLL NCI-WG guidelines (2018 Edition) and indicating at least one of the criteria for treatment (see Appendix 14: Treatment Criteria).
- Measurable disease (peripheral blood lymphocyte ≥ 5 × 109/L, or enlargement of lymph nodes (baseline LDi ≥ 1.5 cm), or hepatomegaly or splenomegaly caused by CLL/SLL).
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 to 2
- QT interval corrected using the Fridericia's formula (QTcF) on electrocardiogram (ECG): QTcF≤450 ms in males or ≤470 ms in females
- Adequate bone marrow function independent of growth factor support (no growth factor used within 7 days before the first dose of the study drug) and independent of blood transfusion (no whole blood transfusion or blood component transfusion supportive therapy within 7 days before the first dose of the study drug) as follows: Absolute neutrophil count (ANC) ≥ 1.0 × 109/L (ANC ≥ 0.5 × 109/L specified in patients with bone marrow involvement of CLL/SLL) Platelet count ≥ 50 × 109/L; Hemoglobin ≥ 8.0 g/dL.
- Adequate hepatic, renal, and coagulation functions as follows: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 × Upper Limit of Normal (ULN), serum total bilirubin ≤ 1.5 × ULN; Serum creatinine ≤ 1.5 × ULN. If serum creatinine > 1.5 × ULN, creatinine clearance (CrCL) must be ≥ 50 mL/min; International normalized ratio (INR), activated partial thromboplastin time (APTT), and prothrombin time (PT) ≤ 1.5 × ULN.
- Males and females of childbearing potential (only postmenopausal women who have not menstruated for at least 12 months or those surgically sterilized can be considered infertile) and their partners voluntarily take effective contraceptive measures throughout the treatment period and at least 3 months after the last dose of the study drug. Male patients must avoid sperm donation from the first dose of the study drug to three months after the last dose of the study drug.
- Female patients of childbearing potential have negative serum pregnancy test results within approximately 14 days prior to the first dose of the study drug. If the serum pregnancy test results available are > 7 days from the first dose, urine pregnancy test results before the first dose of the study drug must be negative.
What rules you out
- Any previous CLL/SLL-specific treatments (excluding corticosteroids for necessary immediate intervention; only a maximum daily equivalent dose of prednisone less than or equal to 20 mg is allowed within 10 days before starting the study treatment).
- Known to have hypersensitivity to ingredients or analogues of drugs used in the study
- Pregnant or lactating female patients and patients who are expected to become pregnant during the study period or within 3 months after the last dose.
- Patients who have history of other active malignant tumor other than CLL/SLL within 3 years before study entry, except for: • Adequately treated carcinoma in situ of cervix uteri • Completely resected basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin • Confinement and resection of previously cured malignancies (or other treatments). Note: If patients stopped antitumor treatment for ≥3 years and there was no tumor recurrence for ≥3 years prior to joining the study, these patients could be enrolled.
- Malabsorption syndrome or other conditions not suitable for enteral administration.
- Other clinically significant uncontrolled symptoms, including but not limited to: uncontrolled active systemic infection (virus, bacteria or fungi), known clinically active hepatitis B or C, or HIV infection.
- Primary active autoimmune and connective tissue diseases, such as active and uncontrolled primary autoimmune cytopenia, including autoimmune hemolytic anemia (AIHA) and primary immune thrombocytopenia (ITP).
- Any other condition or circumstance that would, at the discretion of the investigator, make the patient unsuitable for the study.
- TP53 mutation or del (17p).
- Transformation to invasive Non-Hodgkin’s lymphoma (e.g., Richter’s transformation, prolymphocytic leukaemia or diffuse large B-cell lymphoma) or leukaemia involving the central nervous system. If Richter’s transformation is suspected, PET-CT or biopsy should be performed to rule it out.
- Use of any of the following treatments within 14 days or 5 half-lives before the first dose of the study drug, or clinically significant adverse reactions/toxicities that are related to previous treatments not recovered to < Grade 2: Anti-tumor therapies include chemotherapy, radiotherapy, anti-tumor steroid treatment, anti-tumor Chinese medicine treatment; investigational treatment including targeted small molecule drugs.
- Use of the moderate to strong CYP3A inhibitors, such as fluconazole, ketoconazole and clarithromycin, within 7 days or 5 half-lives (whichever is shorter) before the first dose of the study drug; or use of strong CYP3A inducers, such as rifampicin, carbamazepine, phenytoin, and St. John's wort, within 14 days before the first dose of the study drug.
- Failure to fully recover adequately from prior surgical procedures at the discretion of the investigator. Patients who receive a major surgery within 28 days prior to the first dose of the study drug or who receive a minor surgery (excluding biopsy) within 14 days prior to the initiation of the study
- Presence of significant cardiovascular diseases, such as symptomatic arrhythmia, congestive heart failure, myocardial infarction, or any New York Heart Association (NYHA) grade 3 or 4 cardiovascular disease within 6 months before study entry. Note: Patients with controlled, asymptomatic atrial fibrillation are allowed to participate in this study.
- A history of significant renal, neurological, psychiatric, pulmonary, endocrine, metabolic, immune, cardiovascular, or hepatic disease, which will have an adverse effect on the patient if he/she participates in the study, at the discretion of the investigator. Those requiring intervention for any of the above diseases in the past 6 months must be discussed by the investigator and the sponsor.
- Patients who require warfarin (potential drug-drug interactions may increase exposure to warfarin and related complications) or other anticoagulants or active hemorrhage occur within 2 months before study entry
The study team makes the final eligibility decision.
Where it's taking place
- Korea, Republic of
- Turkey
- China
- Argentina
- Russian Federation
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Korea, Republic of; Turkey; China; Argentina; Russian Federation. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.