临床试验/2024-511567-28-01

2024-511567-28-01尚未招募2 期

A Phase II Open Label Study of Brentuximab Vedotin in Combination with CHEP in Patients with Previously Untreated CD30-expressing Peripheral T-cell Lymphomas (PTCL)

Kooperativni Lymfomova Skupina z.s.7 个研究点分布在 1 个国家目标入组 33 人开始时间: 2024年8月27日最近更新: 2024年8月27日

适应症

试验速览

阶段: 2 期
状态: 尚未招募
发起方
入组人数: 33
试验地点: 7
主要终点: Primary Endpoint 1. PET-negative complete response (CR) rate at the end of treatment

研究概览入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Primary Objective To assess efficacy (based on Lugano 2014 criteria) of brentuximab vedotin in combination with CHEP.

Key Secondary Objective To assess safety and tolerability of brentuximab vedotin in combination with CHEP.

研究设计

研究类型: Interventional clinical trial of medicinal product

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: 否

入选标准

•Age >18 years
•Written informed consent
•Histologically confirmed diagnosis of CD30-expressing PTCL. The following histological subtypes according to the Revised European-American Lymphoma World Health Organization (WHO) 2016 classification are eligible: a. Systemic anaplastic large cell lymphoma (ALCL) ALK+ with age-adjusted international prognostic index (aaIPI) ≥1 b. Systemic anaplastic large cell lymphoma (ALCL) ALK- c. Peripheral T-cell lymphoma not otherwise specified (PTCL-NOS) d. Angioimmunoblastic T-cell lymphoma (AITL) e. Adult T-cell leukaemia/lymphoma (ATLL; acute and lymphoma types only, must be positive for human T cell leukaemia virus 1) f. Enteropathy-associated T-cell lymphoma (EATL) g. Hepatosplenic T-cell lymphoma h. Monomorphic epitheliotropic intestinal T-cell lymphoma (MEITCL) i. Indolent T-cell lymphoproliferative disorder (T-LPD) of the gastrointestinal (GI) tract j. Follicular T-cell lymphoma k. Nodal peripheral T-cell lymphoma with T-follicular helper (TFH) phenotype
•Positive CD30 expression by local pathology assessment.
•Patients must have at least one measurable disease site. The lesion must be fluorodeoxyglucose (FDG)-avid by PET and must have a greatest transverse diameter of ≥1.5 cm and greatest perpendicular diameter of ≥1.0 cm by CT, as assessed by the site radiologist.
•Eastern Cooperative Oncology Group (ECOG, Appendix B) performance status of 0 to 1
•Patient must be autologous stem cell transplant (ASCT)-eligible
•Patient must be appropriate candidate for treatment with anthracyclines
•Patient must have the following laboratory criteria at screening: a. Absolute neutrophil count (ANC) ≥ 1.0 x 109/L (unless secondary to bone marrow involvement by PTCL) b. Platelet count ≥ 50 x 109/L (unless secondary to bone marrow involvement by PTCL) c. Total serum bilirubin < 1.5 × upper limit of normal (ULN) unless secondary to Gilbert’s syndrome or documented liver involvement by lymphoma. Patients with Gilbert’s syndrome or documented liver involvement by lymphoma may be included if their total bilirubin is ≤3 × ULN d. Alanine transaminase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP) ≤3 × ULN, or <5 × ULN in cases of documented liver involvement by lymphoma e. Serum creatinine clearance must be >50 mL/minute/1.73m2 either measured or calculated using a standard Cockcroft and Gault formula (Cockroft and Gault, 1976, Appendix A).
•Females of childbearing potential (FCBP) must not be pregnant or breastfeeding and must agree to use two effective contraception methods (at least one highly-effective method and one additional acceptable (barrier) method, see Appendix G) each time engaging in sexual activity with a male during the study treatment and for 12 months following the last dose of treatment. FCBP must refrain from donating oocyte during the course of study or for 12 months following the last dose of treatment, whichever is longer.
•Male participants must agree to use condom each time they have sex with a woman of childbearing potential during the study treatment and for 6 months following the last dose of treatment. In addition to the use of condom by male participants, their female partners who are of childbearing potential must use one highly effective contraception method (see Appendix G) at the same time. Male participants must refrain from donating sperm during the study participation or for 6 months following the last dose of treatment, whichever is longer.
•In the opinion of investigator, the patient must: a. be able to understand, give written informed consent, and comply with all study-related procedures, medication use, and evaluations b. not have a history of noncompliance in relation to medical regimens or be considered potentially unreliable and/or uncooperative

排除标准

•Patients must be excluded from participating in this clinical trial if they meet any of the following criteria:
•Current diagnosis of any following lymphomas: a. Primary cutaneous CD30-positive T-cell lymphoproliferative disorders and lymphomas. Cutaneous ALCL with extracutaneous tumour spread beyond locoregional lymph nodes is eligible (previous single-agent treatment to address cutaneous and locoregional disease is permissible) b. Mycosis fungoides (MF), including transformed MF c. PTCL CD30-negative
•History of another primary invasive cancer, hematologic malignancy, or myelodysplastic syndrome that has not been in remission for at least 3 years. Exceptions are malignancies with a negligible risk of metastasis or death (e.g., 5-year OS ≥90%), such as carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer.
•History of progressive multifocal leukoencephalopathy (PML).
•Known central nervous system (CNS) lymphoma involvement
•Prior treatment with brentuximab vedotin.
•Baseline peripheral neuropathy ≥Grade 2 (per the NCI CTCAE, Version 5.0)
•Left ventricular ejection fraction (LVEF) of < 45% or history of myocardial infarction ≤6 months, or symptomatic cardiac disease (including symptomatic ventricular dysfunction, symptomatic coronary artery disease, and symptomatic arrhythmias) or prior treatment with anthracyclines.
•Any uncontrolled Grade 3 or higher (per the National Cancer Institute’s Common Terminology Criteria for Adverse Events, NCI CTCAE Version 5.0) viral, bacterial, or fungal infection within 2 weeks prior to the first dose of study treatment.
•Known human immunodeficiency virus (HIV) infection, hepatitis B surface antigen-positive status, or known or suspected active hepatitis C infection.
•History of hypersensitivity to any component of CHEP, to compounds of similar biological or chemical composition as brentuximab vedotin, and/or the excipients contained in any of the drug formulations of study treatment.
•Females who are pregnant or breastfeeding
•Planned CNS prophylaxis with intravenous high-dose methotrexate.
•Vaccination with live vaccine within 30 days prior to study treatment
•Any contraindication for brentuximab vedotin, cyclophosphamide, doxorubicin, etoposide or prednisone according to the respective SmPCs.
•Severe hepatic or renal impairment.

结局指标

主要结局

Primary Endpoint 1. PET-negative complete response (CR) rate at the end of treatment

次要结局

Key Secondary Endpoints 2. Type, incidence, severity, seriousness, and relatedness of treatment emergent adverse events. 3. Type, incidence, severity, seriousness, and relatedness of adverse events in the follow-up period. Secondary Endpoints 1. Progression-free survival (PFS) 2. Overall survival (OS) 3. Event-free survival (EFS) 4. Objective Response Rate (ORR) at the end of treatment 5. Rate of pre-planned upfront HDT/ASCT 6. Duration of response (DoR) Exploratory Endpoints 1. Descript

研究者

发起方

Kooperativni Lymfomova Skupina z.s.

申办方类型

Patient organisation/association

责任方

Principal Investigator

主要研究者

prof. MUDr. Marek Trneny, CSc.

Scientific

Kooperativni Lymfomova Skupina z.s.

研究点 (7)

Loading locations...

相似试验

进行中（未招募）

1 期

EUCTR2019-003982-17-ITSEATTLE GENETICS, INC.100

进行中（未招募）

1 期

Phase 2 study of Brentuximab Vedotin associated with CHP followed by consolidation with high-dose therapy / autologous stem-cell transplantation as frontline treatment of patients with enteropathy-associated T-cell lymphoma type 1.

EUCTR2016-002782-57-FRInstitut des maladies génétiques - Imagine25

进行中（未招募）

1 期

A phase II study of Brentuximab Vedotin (BV) in the treatment of elderly Hodgkin lymphoma (HL) patients at first relapse or with primary refractory diseaseelderly Hodgkin lymphoma (HL) patients at first relapse or with primary refractory disease

EUCTR2013-004109-24-ITFondazione Italiana Linfomi Onlus20

进行中（未招募）

1 期

Brentuximab vedotin+Adriamycin, vinblastine, and dacarbazine in pediatric patients with advanced stage newly diagnosed Hodgkin lymphoma

EUCTR2015-004112-38-ESMillennium Pharmaceuticals Inc.59

进行中（未招募）

1 期

Brentuximab vedotin+Adriamycin, vinblastine, and dacarbazine in pediatric patients with advanced stage newly diagnosed Hodgkin lymphoma

CTIS2023-506415-18-00Takeda Development Center Americas Inc.59