EUCTR2018-003748-22-DE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 biopsy-proven CTCL, MF subtype, clinical stage I-III, with staging based on Screening assessments and following staging parameters set in the protocol.
- •3. Must have participated in the comparator arm of the SOLAR clinical trial (SOLAR: A Phase 2, Randomized, Open-label, Parallel-group, Active Comparator, Multi-center Study to Investigate the Efficacy and Safety of Cobomarsen (MRG-106) in Subjects with Cutaneous T-Cell Lymphoma (CTCL), Mycosis Fungoides (MF) Subtype, Protocol Number: MRG106-11-201, EUDRACT Number: 2018-000727-13) 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.
- •4. 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).
- •5. 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.
- •6. Subjects of childbearing potential must agree to use highly effective methods of contraception as defined in the protocol.
- •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.
- •16. History of intolerance, adverse or allergic reactions to oligonucleotide products and/or phosphate buffer solutions.
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