2025-524795-35-00招募中4 期
Phase IV study evaluating the efficacy and safety of the venetoclax + rituximab (VR) regimen in patients with relapsed chronic lymphocytic leukemia in Polish clinical practice
Uniwersytet Medyczny W Lublinie6 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2026年4月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 36
- 试验地点
- 6
- 主要终点
- Percentage of patients treated with venetoclax + rituximab (VR) achieving uMRD status, i.e. MRD values <10-4 determined by flow cytometry
研究概览
简要总结
Evaluation of the efficacy of venetoclax + rituximab (VR) treatment in clinical practice, based on the percentage of patients achieving MRD negativity (uMRD, MRD<10-4)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Exclusion of pregnancy and breastfeeding
- •Patient consent to contraception in accordance with the relevant, current Summary of Product Characteristics
- •Absence of active, severe infections
- •Absence of significant comorbidities or clinical conditions constituting a contraindication to therapy, as determined by the attending physician based on the relevant, current Summary of Product Characteristics
- •Adequate organ function, determined on the basis of laboratory blood test results, enabling, in the opinion of the attending physician, safe commencement of therapy
- •Prior treatment for CLL or SLL, including chemotherapy, BTK inhibitor therapy, venetoclax, small molecule signaling inhibitor, or monoclonal antibody therapy with response to previous venetoclax treatment > 36 months from last dose
- •Adequate hematologic function independent of growth factors or transfusion support, according to the local laboratory reference range at screening (unless due to underlying disease, as evidenced by extensive bone marrow involvement or hypersplenism secondary to splenic lymphoma according to the investigator), defined as follows: • Hemoglobin ≥ 9 g/dL • Absolute neutrophil count ≥ 1.0 × 109/L • Platelet count ≥ 75 × 109/L
- •Adequate renal function, according to the local laboratory reference range at screening, as indicated by: Calculated creatinine clearance ≥ 30 mL/min/1.73 m² using 24-hour creatinine clearance or the modified Cockcroft-Gault equation (eCCR; using ideal body weight [IBM] instead of weight)
- •Normal liver function, according to the local laboratory reference range for screening, as indicated by: • AST and ALT ≤ 2.5 × ULN • Total bilirubin ≤ 1.5 × ULN (or ≤ 3 × ULN in patients with documented Gilbert's syndrome)
- •Absence of active hemolytic anemia requiring immunosuppressive or other pharmacological treatment. Patients with a positive Coombs test but no evidence of hemolysis are NOT excluded from participation in the study
- •Obtaining the patient's informed voluntary consent to participate in the study
- •No current use of corticosteroids. EXCEPTION: Low-dose steroids (<10 mg prednisone or equivalent dose of another steroid) are permitted for the treatment of non-hematological conditions (e.g., chronic adrenal insufficiency)
- •No prior autoimmune complications (e.g., autoimmune hemolytic anemia or immune thrombocytopenia) that have developed since the initial diagnosis of CLL and required treatment with high-dose corticosteroids (e.g., equivalent to >20 mg prednisone daily), monoclonal antibody-based therapy, or chemotherapy. Previous use of corticosteroids for reasons other than the treatment of autoimmune complications of CLL is permitted
- •No major surgery within 4 weeks (28 days) of the first dose of study drug or minor surgery within 3 days of the first dose of study drug
- •No radiotherapy ≤ 4 weeks before starting study treatment
- •The patient must be able to take a xanthine oxidase inhibitor or rasburicase for tumor lysis syndrome (TLS) prophylaxis
- •Negative pregnancy test result (serum βHCG concentration) for women of reproductive age (including premenopausal women who have had tubal ligation) and for all women who do not meet the definition of postmenopausal (≥ 24 months of amenorrhea) and who have not undergone surgical sterilization through hysterectomy and/or bilateral oophorectomy. For all other women, documentation confirming that the patient is not of reproductive age should be provided in the medical interview. ● Patients who are not surgically sterile or postmenopausal must agree to the simultaneous use of two reliable forms of contraception or to complete abstinence from heterosexual intercourse during the study. ● Men must agree to use a latex condom during sexual contact with women of reproductive age during the study and for at least 28 days after discontinuing the study, even if they have had a successful vasectomy
- •Ability and willingness to comply with the requirements of the study protocol
- •The patient must have a diagnosis of CLL (CLL or SLL) that meets the criteria published in 2018 iwCLL
- •Meeting the criteria for qualifying for therapy under the B.79 drug program
- •Performance status 0-2 according to the ECOG scale
- •Presence of indications for treatment according to the International Workshop on Chronic Lymphocytic Leukemia updating (the National Cancer Institute-Working Group (iwCLL)
- •There are no contraindications to the use of the drug in accordance with the current Summary of Product Characteristics
- •No hypersensitivity to any drug or mouse proteins or any of the excipients of the drug
排除标准
- •Disease progression during treatment, including transformation to a more aggressive lymphoma
- •Occurrence of hypersensitivity symptoms to any of the drugs used or to mouse proteins or to any of the excipients of the drug, preventing continuation of treatment
- •Occurrence of unacceptable or life-threatening toxicity despite appropriate management
- •Occurrence of progressive multifocal leukoencephalopathy or severe skin reactions (toxic epidermal necrolysis, Stevens-Johnson syndrome) – in case of venetoclax therapy in combination with anti-CD20 antibody
- •Uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia – in the case of therapy with venetoclax as monotherapy or in combination with an anti-CD20 monoclonal antibody or ibrutinib
- •Pregnancy or breastfeeding
- •The occurrence of diseases or conditions which, in the opinion of the attending physician, make further treatment impossible
- •Lack of cooperation or failure to follow medical recommendations, including those regarding periodic check-ups to assess the effectiveness and safety of treatment, on the part of the beneficiary or his/her legal guardian
研究组 & 干预措施
MabThera 100 mg concentrate for solution for infusion
Comparator
干预措施: MabThera 100 mg concentrate for solution for infusion (Drug)
Venclyxto 10 mg film-coated tablets, Venclyxto 100 mg film-coated tablets, Venclyxto 50 mg film-coated tablets
Test
干预措施: Venclyxto 10 mg film-coated tablets (Drug)
Venclyxto 10 mg film-coated tablets, Venclyxto 100 mg film-coated tablets, Venclyxto 50 mg film-coated tablets
Test
干预措施: Venclyxto 100 mg film-coated tablets (Drug)
Venclyxto 10 mg film-coated tablets, Venclyxto 100 mg film-coated tablets, Venclyxto 50 mg film-coated tablets
Test
干预措施: Venclyxto 50 mg film-coated tablets (Drug)
结局指标
主要结局
Percentage of patients treated with venetoclax + rituximab (VR) achieving uMRD status, i.e. MRD values <10-4 determined by flow cytometry
Percentage of patients treated with venetoclax + rituximab (VR) achieving uMRD status, i.e. MRD values <10-4 determined by flow cytometry
次要结局
- Percentage of patients achieving ORR, PR, CR and Cri, uMRD, treated according to the VR regimen in the Ministry of Health drug program, taking into account pharmacoeconomic and systemic parameters including the number of days of hospitalization and visits during 24 months
- Percentage of patients achieving ORR, PR, CR and Cri, uMRD with negative prognostic factors: TP53 deletion/mutation, unmutated IGHV gene and high CD38 expression
- Occurrence and correlation with treatment outcomes of potential biomarkers, including cytogenetic abnormalities detected by FISH, mutational status of the IGVH gene and TP53 mutations assessed by Sanger or next-generation sequencing (NGS), in patients treated according to the VR regimen
- Results of the QLQ-C30 (EORTC QLQ-C30) questionnaires assessing quality of life (QoL), completed by patients before and during treatment
- Number of days of hospitalization in each of the studied regimens, taking into account the period related to venetoclax titration
研究者
Krzysztof Giannopoulos
Scientific
Uniwersytet Medyczny W Lublinie
研究点 (6)
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