CTIS2024-511633-35-00招募中1 期
Consolidation with ADCT-402 (loncastuximab tesirine) after a short course of immunochemotherapy: a phase II study in BTKi-treated (or BTKi intolerant) Relapsed/Refractory (R/R) Mantle Cell Lymphoma (MCL) patients - FIL_COLUM
Fondazione Italiana Linfomi Ets0 个研究点目标入组 49 人开始时间: 2024年6月3日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 49
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Histologically documented diagnosis of MCL as defined in the 2017 edition of the World Health Organization (WHO) classification;, ECOG/WHO performance status = 2 (unless MCL-related);, The following laboratory values at screening (unless due to bone marrow involvement by lymphoma): - Absolute neutrophil count (ANC) ? 1.0×109/L, - Platelets ? 75.000/mm3, - Creatinine clearance = 40 mL/min (Cockcroft-Gault formula); - Aspartate transaminase (AST) and alanine transaminase (ALT) = 3.0 x ULN; - Bilirubin =1.5 x ULN (unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic origin);, Subject understands and voluntarily signs an informed consent form approved by the National Ethic Committee (NEC), prior to the initiation of any screening or study-specific procedures, Subject must be able to adhere to the study visit schedule and other protocol requirements;, Life expectancy = 3 months;, Women of childbearing potential (WOCBP) must agree to use effective contraception if sexually active. This applies for the time period between signing of the informed consent form and at least 10 months after last loncastuximab tesirine (ADCT-402) dose. Men with female partners who are of childbearing potential must agree to use effective contraception if sexually active. This applies for the time period between signing of the informed consent form and at least 7 months after last loncastuximab tesirine (ADCT-402) dose., Age = 18 and < 85 years, Relapsed/Refractory disease after one, two, three or four lines of treatment;, Bendamustine-naive or relapsed after at least one year after the last cycle of a bendamustine-containing regimen, Previous treatment with BTKi monotherapy or BTKi containing regimens with R/R disease; and/or patients who discontinued BTKi monotherapy or BTKi containing regimens for adverse events and have active disease necessitating treatment;, Previous treatment with any anti-CD19 agents is allowed (included CAR-T treatment) If previous anti-CD19 treatment has occurred, tissue CD19 expression must be assessed by histology or flow cytometry., Venetoclax treated patients are allowed;, Stem cell transplant eligible patients are allowed;, Measurable nodal or extranodal disease = 1.5 cm in longest diameter, and measurable in 2 perpendicular dimensions. Note: Patients with bone marrow involvement only are eligible. In case of bone marrow infiltration only, bone marrow aspiration and biopsy are mandatory for all staging evaluations;
排除标准
- •Subjects who have received a bendamustine containing regimen and relapsed less than one year after the end of treatment, Evidence of other clinically significant uncontrolled condition(s) including, but not limited to: - Uncontrolled and/or active systemic infection (viral including COVID 19, bacterial or fungal); - Chronic or acute hepatitis B (HBV) or hepatitis C (HCV) requiring treatment. Note: subjects with serologic evidence of prior vaccination to HBV (i.e., HBsAg negative, HBsAb positive and HBcAb negative) or positive HBcAb from previous infection or intravenous immunoglobulins (IVIG) may participate; inactive carriers (HBsAg positive with undetectable HBV DNA) are eligible. Patients with presence of HCV antibody are eligible only if PCR result are negative for HCV RNA;, HIV seropositivity;, Lymphoma with active CNS involvement at the time of screening, including leptomeningeal disease;, Congenital long QT syndrome or a corrected QTcF interval of >480 msec at screening (unless secondary to pacemaker or bundle branch block);, Any other significant medical illness, abnormality, or condition that would, in the investigator's judgment, make the patient inappropriate for study participation or put the patient at risk;, If female, the patient is pregnant or breast-feeding., Known history of hypersensitivity to human antibodies;, Allogenic stem cell transplant within 6 months prior to start of first study drug;, Allogenic stem cell transplant with active / uncontrolled graft-versus-host disease;, More than four lines of previous treatment (autologous stem cell transplant performed as part of consolidation to a previous line of therapy should not be considered as a line of therapy);, Active second malignancy in the last three years other than non-melanoma skin cancers, non-metastatic prostate cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast, or any other tumor that the Sponsor and Coordinating Investigator agree and document should not be considered preclusive to participate in the study;, Major surgery or any anticancer therapy including chemotherapy, immunotherapy, radiotherapy, investigational therapy, including targeted small molecule agents within 14 days prior to start of study drug (R-BAC). A shorter interval in special settings must be approved by the Sponsor and/or Investigator;, Cardiovascular disease (NYHA class =2);, Significant history of neurologic, psychiatric, endocrinological, metabolic, immunologic, or hepatic disease that would preclude participation in the study or compromise ability to give informed consent;
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