2024-513426-29-00招募中2 期
International prospective Phase 2 trial addressing the efficacy of first-line Chlamydophila psittaci-eradicating therapy with protracted administration of doxycycline followed by eradication monitoring and antibiotic re-treatment at infection re-occurrence in patients with newly diagnosed Ocular Adnexal Marginal Zone Lymphoma (OAMZL)
Association International Extranodal Lymphoma Study Group (IELSG)8 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2025年1月13日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 44
- 试验地点
- 8
- 主要终点
- The primary endpoint is the 2-year progression-free survival (PFS) of patients with newly diagnosed stage-IE OAMZL treated with the experimental strategy
研究概览
简要总结
To establish in a prospective, multicentre phase 2 trial, the efficacy of an upfront targeted therapy consisting of Chlamydophila psittaci (Cp)-eradicating therapy with prolonged administration of doxycycline followed by eradication monitoring and antibiotic re-treatment at infection re-occurrence in patients with newly diagnosed OAMZL.
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
- 是
入选标准
- •Histological diagnosis of OAMZL
- •No previous or concurrent malignancies with the exception of surgically cured carcinoma in situ of the cervix, carcinoma of the skin, prostatic cancer, or other cancers without evidence of disease at least from 5 years
- •Absence of any familial, sociological or geographical condition potentially hampering compliance with study & follow-up schedule
- •Sexually active patients of childbearing potential must implement adequate contraceptive measures during study participation
- •No concurrent treatment with other experimental drugs
- •Patient-signed informed consent obtained before registration
- •Single or bilateral lesion (stage IE) localized to the ocular adnexae (conjunctiva, lachrymal gland or sac, orbit soft tissue)
- •Absence of B symptoms
- •Previously untreated patients
- •No systemic antibiotic therapy in the last 3 months
- •Age >18 years
- •ECOG PS 0-2
- •Negative HIV, HBV and HCV serology
- •Adequate bone marrow, renal, and hepatic function
排除标准
- •Pregnant or lactating women
- •Known allergy to tetracycline
- •Patients unwilling to comply with the requirements of follow-up
- •Myasthenia gravis (tetracycline can exacerbate muscle weakness)
- •Systemic lupus erythematous (tetracycline can exacerbate this condition)
- •Patients with large or rapidly enlarging tumours requiring immediate radiotherapy
- •Obstructive disorders of the esophagus, such as stenosis or achalasia
结局指标
主要结局
The primary endpoint is the 2-year progression-free survival (PFS) of patients with newly diagnosed stage-IE OAMZL treated with the experimental strategy
The primary endpoint is the 2-year progression-free survival (PFS) of patients with newly diagnosed stage-IE OAMZL treated with the experimental strategy
次要结局
- Feasibility
- Tolerability of prolonged administration of doxycycline
- Activity (overall response rate)
- Overall survival
- Cp eradication rate
- Infection re-occurrence rate
- Assessment of prevalence of IRTA1 marker in OAMZL
- Assessment of genetic lesions and gene expression changes in OAMZL and their possible relationship with Cp infection and response to treatment
- Identification of possible SNPs associated with Cp infection in OAMZL patients
- Identification of possible bacterial polymorphisms responsible for antibiotic resistance, infection recurrence or persistence
研究者
IELSG Operations Office
Scientific
Association International Extranodal Lymphoma Study Group (IELSG)
研究点 (8)
Loading locations...
相似试验
招募中
2 期
Clinical Trial to Evaluate the Efficacy and Safety of Pirtobrutinib With Rituximab in Patients With Mantle Cell LymphomaNCT07285590Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea50
招募中
2 期
Phase 2 Trial to determine the safety and efficacy of simultaneous treatment with ruxolitinib and extracorporeal photopheresis for patients with steroid-refractory chronic Graft-versus-Host-Disease (SR-cGvHD) - RUX-ECP2023-507754-33-00Medical Center - University Of Freiburg40
已完成
1 期
A single-centre, open-label, phase I trial evaluating the pharmacokinetics of single ascending oral doses of IRL757 in healthy elderly volunteers2024-515124-36-00Integrative Research Laboratories Sweden AB12
招募中
1 期
A Multicentre, Randomised Phase Ib Trial to evaluate Neoadjuvant Immunotherapy Combination of Nivolumab alone or plus Ipilimumab with the IL-2 Superkine MDNA11 alone or with Tocilizumab in Patients with High-Risk, Surgically Resectable Melanoma – NEO-CYT2024-519010-31-00Fondazione Melanoma Onlus80
已完成
4 期
This is a study to evaluate dose-flexibility of Upadacitinib in Adult Subjects with Moderate to Severe Atopic Dermatitis2023-504869-23-00AbbVie Deutschland GmbH & Co. KG272