Pivotal Open-label Phase 3 Clinical Study of QTX-2101 in Adult Patients With Acute Promyelocytic Leukemia

Официальное название

A Pivotal Open-label Phase 3 Clinical Study Evaluating the Efficacy and Safety of QTX-2101 in Combination With All-trans Retinoic Acid in Newly Diagnosed, Low-risk Acute Promyelocytic Leukemia

Обзор

This Phase 3 study in adult participants with newly diagnosed low-risk APL will evaluate the efficacy, safety, and PK of an oral capsule formulation of ATO, in combination with ATRA.

Вмешательства

• Препарат QTX-2101 + ATRA
  The experimental regimen consists of IV ATO administered once daily during induction, given continuously, for up to a maximum of 60 days. During consolidation, QTX-2101 is administered once daily, per investigator's protocol. ATRA is administered orally in two divided daily doses during induction, given continuously until bone marrow remission (not exceeding 60 days). During consolidation, ATRA is taken orally in two divided daily doses following a 2-weeks-on / 2-weeks-off schedule within each 8
• Препарат IV arsenic trioxide (ATO) + ATRA
  The comparator regimen consists of IV ATO administered once daily during induction, given continuously, for up to a maximum of 60 days. During consolidation, IV ATO is administered once daily, per investigator's protocol. ATRA is administered orally in two divided daily doses during induction, given continuously until bone marrow remission (not exceeding 60 days). During consolidation, ATRA is taken orally in two divided daily doses following a 2-weeks-on / 2-weeks-off schedule within each 8-wee

Первичные конечные точки

• Maximum observed plasma (concentration (Cmax) of QTX-2101 for ASIII [Срок оценки: Up to 1 cycle of consolidation therapy (each cycle is 8 weeks)]
• Molecular complete remission (molecular CR) rate [Срок оценки: Up to 60 days of induction and 3 8-week cycles of consolidation treatment]

Вторичные конечные точки (8)

• To characterize the safety and tolerability of QTX-2101/ATRA and IV ATO/ATRA [Срок оценки: Throughout approximately 10 months of study treatment]
• To characterize the event-free survival (EFS) of QTX-2101/ATRA [Срок оценки: Assessed for up to 3 years after the first dose of treatment, or until treatment failure (disease progression), death, or study completion, whichever occurs first]
• Area under the plasma concentration-time curve (AUC) of QTX-2101 for ASIII [Срок оценки: Up to 10 months]
• To complete a model-based concentration QT relationship evaluation [Срок оценки: Up to 10 months]
• EORTC QLQ-C30 domain unit of measure and measurement tool [Срок оценки: Up to 10 months]
• EQ-5D-5L domain unit of measure and measurement tool [Срок оценки: Up to 10 months]
• Overall Survival [Срок оценки: Assessed for up to 3 years after the first dose of treatment, or until treatment failure (disease progression), death, or study completion, whichever occurs first]
• Event Free Survival (EFS) [Срок оценки: Assessed for up to 3 years after the first dose of treatment, or until treatment failure (disease progression), death, or study completion, whichever occurs first]

Критерии участия

Критерии включения

• Informed Consent
• Participants must be between 18 and under 71 years of age
• Participants must have a confirmed diagnosis of APL proven by standard genetic testing (t(15;17) or PML-RARA)
• Participants must be classified as low- or intermediate-risk APL
• Participants must be willing and able to comply with the scheduled study visits, treatment plans, laboratory tests, contraception guidance, and other procedures

Критерии исключения

• Participants who have significant heart rhythm problems including long QT syndrome, serious arrhythmias, very slow heart rate, or prolonged QTc on ECG
• Participants who have central nervous system leukemia
• Participants having serious ongoing medical conditions or infections including uncontrolled infections, severe organ disease, or conditions that make study participation unsafe
• Participants who are pregnant, breastfeeding, or unwilling to use contraception
• Participants who are unable to safely take study medication, including severe neuropathy, inability to swallow oral medication, malabsorption issues, or known allergy to ATO or ATRA

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

США · 11 центров

• Quetzal Site 16 — Birmingham
• Quetzal Site 1 — Duarte
• Quetzal Site 7 — Los Angeles
• Quetzal Site 5 — Stanford
• Quetzal Site 13 — Augusta
• Quetzal Site 4 — Buffalo
• Quetzal Site 2 — The Bronx
• Quetzal Site 8 — Columbus
• … и ещё 3 центра

Испания · 4 центра

• Quetzal Site 11 — Palma de Mallorca
• Quetzal Site 15 — Barcelona
• Quetzal Site 10 — Cáceres
• Quetzal Site 9 — Valencia

Франция · 1 центр

• Quetzal Site 14 — Paris

Идентификаторы

NCT: NCT07504458 · QTX-2101-301 · 2025-524810-28-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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