Идёт набор NCT06533761

Eganelisib as Monotherapy and in Combination With Cytarabine in Relapsed/Refractory AML

Фаза I С лечением AML, Adult MDS

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Eganelisib, Eganelisib in combination with cytarabine.
Кому может быть актуально: Состояния в реестре: AML, Adult, MDS. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США, Испания
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Phase 1b Open-Label Study to Evaluate the Safety and Tolerability of Eganelisib as Monotherapy and in Combination With Cytarabine in Patients With Relapsed/Refractory Acute Myeloid Leukemia

Обзор

This is a Phase 1b open-label, multicenter, dose-escalation and dose-optimization study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and anti-tumor efficacy of eganelisib as monotherapy and in combination with cytarabine in patients with relapsed/refractory (r/r) acute myeloid leukemia (AML) or r/r higher-risk myelodysplastic syndromes (HR-MDS). The study consists of 2 parts: * Part 1: Dose Escalation (DE) in both monotherapy and in combination. * Part 2: Dose Optimization

Вмешательства

Препарат Eganelisib
eganelisib will be administered as monotherapy
Препарат Eganelisib in combination with cytarabine
eganelisib will be administered in combination with cytarabine

Первичные конечные точки

Incidence and severity of adverse events (AEs), graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0 [Срок оценки: 12 months]
Incidence and severity of dose-limiting toxicities (DLTs) in DLT evaluable patients during Cycle 1 [Срок оценки: 28-35 days]
Preliminary clinical activity as evaluated per European LeukemiaNet (ELN) 2022 criteria for AML and International Working Group (IWG) 2023 criteria for HR-MDS [Срок оценки: 12 months]

Вторичные конечные точки (5)

Area under the plasma concentration time curve extrapolated to the last measurable time point [AUClast] of eganelisib and cytarabine [Срок оценки: 112 days]
Maximum concentration [Cmax] of eganelisib and cytarabine [Срок оценки: 112 days]
Time of maximum concentration [Tmax] of eganelisib and cytarabine [Срок оценки: 112 days]
Plasma half-life [t1/2] of eganelisib and cytarabine [Срок оценки: 112 days]
Measure plasma concentrations of eganelisib and determine model-based PK parameters [Срок оценки: 112 days]

Критерии участия

Критерии включения

Pathological diagnosis of either: AML according to World Health Organization (WHO) 2022 revised criteria per the local pathology report and with ≥10% bone marrow blasts (acute promyelocytic leukemia is excluded but secondary AML and treatment-related AML can be included); Higher-risk (IPSS-R Intermediate, High or Very High Risk at time of study entry) myelodysplastic syndromes (HR-MDS) according to WHO 2022 revised criteria per the local pathology report and with ≥10% bone marrow blasts.
Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
Adequate hepatic and renal function measured within 7 days prior to the first dose of eganelisib.

Критерии исключения

Autologous or allogeneic stem cell transplant within 6 months prior to Cycle 1 Day 1.
Receiving immunosuppressants (eg, cyclosporin) or systemic steroids (except for steroid use as cortisol replacement therapy in documented adrenal insufficiency).
Active fungal disease or uncontrolled infection of any kind; patients receiving antibiotic, antifungal or antiviral treatment must be afebrile and hemodynamically stable for >72 hours prior to treatment
WBC count >25 × 10\^9/L measured within 7 days prior to the first dose of eganelisib (hydroxyurea is permitted to decrease the WBC count).
Presence of a clinically significant non-hematologic toxicity of prior therapy that has not resolved to Grade ≤1 or Baseline, whichever is worst, as determined by NCI CTCAE v 5.0, except alopecia or skin pigmentation. Fatigue and neuropathy must have resolved to Grade ≤2.

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

Здоровые добровольцы: Нет