A Study to Evaluate the Safety and Efficacy of SCTC21C in Combination With Bortezomib, Cyclophosphamide, and Dexamethasone in Patients With Newly Diagnosed Systemic Light-Chain Amyloidosis (NDSLCA)

Официальное название

A Phase 3 Randomized, Open-label, Multicenter Study to Evaluate the Safety and Efficacy of SCTC21C in Combination With Bortezomib, Cyclophosphamide, and Dexamethasone Versus Bortezomib, Cyclophosphamide, and Dexamethasone in Patients With Newly Diagnosed Systemic Light-Chain Amyloidosis

Обзор

The purpose of this study is to evaluate the efficacy and safety of SCTC21C plus cyclophosphamide, bortezomib and dexamethasone (VCd) compared with VCd alone in treatment of newly diagnosed amyloid light chain (AL) amyloidosis participants.

Подробное описание

This study comprises two phases: Part 1 is the safety run in, while Part 2 is a randomized, controlled, open-label, multicenter study. Both parts are divided into three stages: the screening period (up to 28 days before first dose/randomization), the treatment period (from Cycle 1 \[28 days\] Day 1 and continues until disease progression or unacceptable toxicity), and the follow-up period (Postintervention). Safety endpoints include treatment-emergent adverse events , treatment-related adverse events, serious adverse events, clinical laboratory tests, vital signs, physical examinations, electrocardiograms , etc. Efficacy endpoints include Overall Complete Hematologic Response (CHR)，objective response rate (ORR), Hematologic Very Good Partial Response (VGPR) or Better Rate, Overall Survival (OS).

Вмешательства

• Препарат SCTC21C
  Pharmaceutical form: Solution for infusion； Route of administration: Subcutaneous
• Препарат Bortezomib
  Pharmaceutical form: Lyophilized powder for injection； Route of administration: Subcutaneous
• Препарат Dexamethasone
  Pharmaceutical form: Tablets, ampoules or vials for injection； Route of administration: Oral/Intravenous
• Препарат Cyclophosphamide
  Pharmaceutical form: Tablets, ampoules or vials for injection； Route of administration: Oral/Intravenous

Первичные конечные точки

• Percentage of Participants With Overall Complete Hematologic Response (CHR) [Срок оценки: Up to approximately 50 months after the First Participant In (FPI)]

Вторичные конечные точки (6)

• Major Organ Deterioration Progression-Free Survival (MOD-PFS) [Срок оценки: Up to approximately 50 months after the FPI]
• Percentage of Participants Who Achieved Complete Hematologic Response (CHR) at 6 Months [Срок оценки: Month 6]
• Duration of Complete Hematologic Response (CHR) [Срок оценки: Up to approximately 50 months after the FPI]
• Hematologic Very Good Partial Response (VGPR) or Better Rate [Срок оценки: Up to approximately 50 months after the FPI]
• Overall Survival (OS) [Срок оценки: Up to approximately 50 months after the FPI]
• Adverse Events [Срок оценки: Up to approximately 50 months after the FPI]

Критерии участия

Критерии включения

• Histopathological diagnosis of amyloidosis based on detection by immunohistochemistry and polarizing light microscopy of green bi-refringent material in congo red stained tissue specimens or characteristic electron microscopy appearance;
• Measurable disease of amyloid light-chain (AL) amyloidosis;
• One or more organs impacted by AL amyloidosis according to consensus guidelines
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1 or 2

Критерии исключения

• Prior therapy for AL amyloidosis;
• Other amyloidosis;
• Uncontrolled infection.
• Subjects with conditions that may affect safety or efficacy assessments include, but are not limited to, cardiovascular, respiratory, endocrine/metabolic, immune system, hepatic, gastrointestinal (such as gastrointestinal bleeding, perforation, ulcers, etc.), and malignant neoplasms, and are deemed clinically significant by the investigator.
• Subjects who have undergone major surgery or experienced significant trauma within 4 weeks prior to the first use of the investigational drug, or who require elective surgery during the trial period.
• Received a live or attenuated vaccine within 30 days prior to the first dose; Female subjects who are currently breastfeeding.
• Subjects with mental disorders or poor compliance, or other circumstances deemed unsuitable for participation in this study by other investigators.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Peking Union Medical College Hospital — Пекин

Идентификаторы

NCT: NCT07388602 · SCTC21C-B301

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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