EUCTR2018-003748-22-AT进行中（未招募）1 期
PRISM: An Open-label, Multi-Center Extension Study to Investigate the Efficacy and Safety of Cobomarsen (MRG-106) Following Systemic Treatment in Subjects with Cutaneous T-Cell Lymphoma (CTCL), Mycosis Fungoides (MF) Subtype, Who Have Completed the SOLAR Study - PRISM
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Must provide written informed consent (signed and dated), and any authorizations required by law and be able to comply with all study requirements.
- •2. Must have participated in the comparator arm of the SOLAR clinical trial and completed the study (confirmed disease progression). Subjects who discontinued from SOLAR for any reason other than confirmed disease progression on the comparator arm are not eligible.
- •3. Meets the following criteria per the central laboratory at Screening:
- •a. Calculated creatinine clearance = 40 mL/min using 24-hour creatinine clearance OR modified Cockcroft-Gault equation (using ideal body mass [IBM] instead of mass).
- •b. AST and ALT = 2.5 × the ULN; bilirubin = 1.5 × ULN (except subjects with Gilbert's Syndrome who may have bilirubin = 3.0 × ULN following discussion with the Sponsor).
- •4. Females who had a menstrual cycle within 2 years of Screening must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on their first dosing day.
- •5. Subjects of childbearing potential must agree to use highly effective methods of contraception.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •Individuals who meet any of the following exclusion criteria are not to be enrolled in this study.
- •1. Sézary syndrome or mycosis fungoides with B2 involvement, defined as a documented history of B2 and/or B2 staging at the Screening visit. B2 means T-cell clone in peripheral blood + one of the following at Screening:
- •a. = 1000/µL Sézary cells by direct examination OR
- •b. = 1000/µL CD4+ CD26- OR
- •c. = 1000/µL CD4+ CD7-
- •2. Evidence of large cell transformation.
- •3. Evidence of visceral involvement related to MF at Screening.
- •4. Unresolved toxicities from prior vorinostat treatment, defined as having not resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, version 5.0), grade 0 or 1.
- •5. Receipt of any the following treatments:
- •Macrolide or tetracycline antibiotics within 28 days prior to Screening;
- •More than 3 short courses of prednisone equivalent > 10 mg per day within 8 weeks prior to Screening; however, a stable regimen of systemic prednisone equivalent to = 10 mg per day (or steroid equivalent) is permitted;
- •Any CTCL systemic therapy after completion of the SOLAR study and prior to Day 1 for PRISM.
- •6. Positive test for blood (including trace) on urinalysis. Subjects with non-clinically significant etiology such as menstrual blood are allowed.
- •7. An active or uncontrolled infection defined as subjects who require systemic antibacterial, antiviral, or antifungal therapy within the last 7 days prior to Screening.
- •8. Clinically significant anemia (hemoglobin < 8 g/dL), neutropenia (absolute neutrophil count [ANC] < 1000/mm3) or thrombocytopenia (platelets < 50,000/mm3) at Screening.
- •9. Presence on ECG of QT interval corrected for heart rate using Fridericia's formula (QTcF) > 450 msec for males or > 470 msec for females or > 480 msec for subjects with bundle branch block, based on a mean of the triplicate ECG measurements collected at Screening.
- •10. Unwillingness to comply with study procedures, including follow-up, as specified by this protocol, or inability to communicate or cooperate fully with the Investigator.
- •11. Lactating or pregnant.
- •12. Major surgery within 4 weeks of the first dose of study treatment.
- •13. Any active, clinically significant, unresolved adverse event (related or unrelated to study drug) from the prior study at the time of Screening.
- •14. Unable to understand the purpose and risks of the study and to provide a signed and dated informed consent form (ICF) and authorization to use protected health information (in accordance with national and local subject privacy regulations).
- •15. Clinically significant abnormalities in medical history, physical examination, or laboratory values that, in the opinion of the Investigator, would make the subject unsuitable for inclusion in the study.
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