2024-512370-94-00招募中2 期
Multicentric phase II trial to evaluate the efficacy and safety of Ibrutinib in combination with rituximab in patients with indolent clinical forms of Mantle Cell Lymphoma.
Fundacion Geltamo12 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年6月13日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 12
- 主要终点
- Rate of complete remission (CR) achieved at 12 months of I+R combination.
研究概览
简要总结
To explore the efficacy of I+R combination as a therapeutic alternative to immuno-chemotherapy (R-CHOP regimen) in indolent forms of MCL by assessing the rate of complete responses achieved at 12 months of treatment.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Subjects with confirmed diagnosis of Mantle Cell Lymphoma (World Health Organization Classification, WHO 2008). Classical, small-cell variants and marginal-zone variants can be included.
- •Stable disease without evidence of clinical progression criteria for at least 3 months. Patients in prolonged therapeutic abstention may be included.
- •Women of childbearing potential and men who are sexually active must be practicing a highly effective method of birth control during and after the study consistent with local regulations regarding the use of birth control methods for subjects participating in clinical trials. Men must agree to not donate sperm during and after the study. For females, these restrictions apply for 1 month after the last dose of study drug. For males, these restrictions apply for 3 months after the last dose of study drug.
- •Women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [ß-hCG]) or urine pregnancy test at Screening. Women who are pregnant or breastfeeding are ineligible for this study.
- •Sign (or their legally-acceptable representatives must sign) an informed consent document indicating that they understand the purpose of and procedures required for the study, including biomarkers, and are willing to participate in the study.
- •Age 18 years or older.
- •Subjects must not have received any prior therapies (excluding diagnostic splenectomy).
- •Asymptomatic patients.
- •Ann Arbor clinical stages I-IV.
- •Eastern Cooperative Oncology Group (ECOG) performance status <2 (0-1).
- •Subjects with a non-nodal MCL presentation with mainly bone marrow or peripheral blood involvement.
- •Other asymptomatic clinical presentations are acceptable in case of low tumor burden, including nodal MCL with lymph node enlargement ≤ 3 cm in the maximum diameter and with low proliferation index (Ki-67 ≤ 30%).
- •The following laboratory values at screening: ● ● Neutrophil count ≥ 1×10e9/L, Hemoglobin level ≥ 100 g/L or platelet count ≥ 100×10e9/L Transaminases (AST and ALT) ≤ 3 x ULN ●Total bilirubin ≤ 1.5 x ULN unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic origin ●Creatinine ≤ 2 x ULN or calculated creatinine clearance ≥ 40 mL/min/1.73m2
排除标准
- •Aggressive histological variants: blastic and pleomorphic variants (blastoid).
- •Known CNS infiltration.
- •Subjects with expected therapy requirement for MCL in a short time (< 3 months).
- •Patients with active hepatitis B or C infection or HIV infection. Positive test results for chronic HBV infection (defined as positive HBsAg serology) or positive test results for hepatitis C (hepatitis C virus [HCV] antibody serology testing) will be excluded with the following exceptions. Patients with occult or prior HBV infection (defined as negative HBsAg and positive total HBcAb) may be included if HBV DNA is undetectable, provided that they are willing to undergo monthly DNA testing or antiviral prophylaxis. Patients who have protective titers of hepatitis B surface antibody (HBsAb) after vaccination or prior but cured hepatitis B are eligible. Patients positive for HCV antibody are eligible only if PCR is negative for HCV RNA.
- •Anticoagulation requirement with vitamin K antagonists.
- •Past medical history of stroke or intracranial haemorrhage within 6 months prior to inclusion
- •Required medication with strong CYP3A4/5 inhibitors.
- •Any serious comorbidity that makes the patient unacceptable for receiving the treatment
- •Concomitant or previous malignancies the last 2 years other than basal skin cancer or in situ uterine cervix cancer.
- •Pregnancy or lactation.
- •Major surgery within 4 weeks of inclusion.
- •Proliferation index measured by Ki-67 > 30%.
- •Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of Screening, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification.
- •Vaccinated with live, attenuated vaccines within 4 weeks of randomization.
- •Uncontrolled systemic infection requiring intravenous (IV) antibiotics.
- •Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator’s opinion, could compromise the subject’s safety, interfere with the absorption or metabolism of ibrutinib capsules, or put the study outcomes at undue risk.
- •B-cell monoclonal lymphocytosis with MCL phenotype.
- •Eastern Cooperative Oncology Group (ECOG) performance status ≥
- •Presence of B symptoms or any relevant symptoms related to the MCL.
- •Nodal clinical forms with lymph node enlargement > 3 cm (maximum diameter).
- •Cytopenias attributable to MCL: Neutrophil count < 1×10e9/L, Hemoglobin level < 100 g/L or platelet count < 100×10e9/L.
- •Organ dysfunction related to MCL including creatinine level > 2 ULN or altered liver biochemistry (> 3x ULN).
- •Gradual increase in different determinations of serum LDH attributable to MCL that exceeds 20% of the ULN.
结局指标
主要结局
Rate of complete remission (CR) achieved at 12 months of I+R combination.
Rate of complete remission (CR) achieved at 12 months of I+R combination.
次要结局
- To determine the overall response rate (ORR) at 12 months, Progression free survival (PFS), duration of response (DOR) and overall survival (OS).
- To determine the rate of negative minimal residual disease (MRD), the time to obtain a molecular response and the median duration of the molecular response in I+R responding patients.
- Rates of AEs, SAEs, and SUSARs by CTC grade (Version 4.03) during I+R treatment
- To assess the health-related quality of life (QOL) during treatment.
- Genomic studies in indolent clinical forms of MCL (IGHV mutational status, DNA copy-number and whole exome sequencing)
研究者
A person designed by the Sponsor
Scientific
Fundacion Geltamo
研究点 (12)
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