Идёт набор NCT06547528

A Phase I Study to Investigate the Tolerability and Safety of ONO-4685 Given as Monotherapy in T Cell Lymphoma and CLL/SLL

Фаза I С лечением Relapsed or Refractory T Cell Lymphoma and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

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: ONO-4685.
Кому может быть актуально: Состояния в реестре: Relapsed or Refractory T Cell Lymphoma and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma. 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: Япония
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

An Open-label, Uncontrolled, Phase I Dose Escalation Study to Investigate the Tolerability and Safety of ONO-4685 Given as Monotherapy in Patients With Relapsed or Refractory T Cell Lymphoma and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)

Обзор

A Phase I Study to Investigate the Tolerability and Safety of ONO-4685 Given as Monotherapy in T Cell Lymphoma and CLL/SLL

Вмешательства

Препарат ONO-4685
ONO-4685 is administered by IV infusion. The administration of ONO-4685 will be continued until disease progression or unacceptable toxicity is observed.

Первичные конечные точки

Dose-limiting toxicities(DLT) [Срок оценки: Up to 3 Weeks]
Incidence and severity of AEs and SAEs [Срок оценки: Through study completion, an average of 1 year]
Laboratory abnormality profile of ONO-4685 as measured by incidence and severity of clinical laboratory abnormalities [Срок оценки: Through study completion, an average of 1 year]
Body temperature [Срок оценки: Through study completion, an average of 1 year]
Pulse rate [Срок оценки: Through study completion, an average of 1 year]
Systolic/diastolic blood pressure [Срок оценки: Through study completion, an average of 1 year]
Change of weight during the trial period [Срок оценки: Through study completion, an average of 1 year]
Chest X-ray test [Срок оценки: Through study completion, an average of 1 year]
ECG parameters by 12 lead ECG(pulse rate) [Срок оценки: Through study completion, an average of 1 year]
ECG parameters by 12 lead ECG(RR) [Срок оценки: Through study completion, an average of 1 year]

Вторичные конечные точки (12)

Best overall response (BOR) [Срок оценки: Through study completion, an average of 1 year]
Overall response rate (ORR) [Срок оценки: Through study completion, an average of 1 year]
Complete response rate (CRR) [Срок оценки: Through study completion, an average of 1 year]
Duration of response (DOR) [Срок оценки: Through study completion, an average of 1 year]
Progression Free Survival(PFS) [Срок оценки: Through study completion, an average of 1 year]
Time to response (TTR) [Срок оценки: Through study completion, an average of 1 year]
Overall Survival(OS) [Срок оценки: Through study completion, an average of 1 year]
The percent change of tumor volume [Срок оценки: Through study completion, an average of 1 year]
Pharmacokinetics(Cmax) [Срок оценки: Through study completion, an average of 1 year]
Pharmacokinetics(Tmax) [Срок оценки: Through study completion, an average of 1 year]
Pharmacokinetics(AUC) [Срок оценки: Through study completion, an average of 1 year]
Pharmacokinetics(Ceoi) [Срок оценки: Through study completion, an average of 1 year]

Критерии участия

Критерии включения

Patients with histopathologically confirmed diagnosis of one of the following subtypes as defined by the 2017 revision of the WHO classification of lymphoid malignancies:

Peripheral T-cell lymphoma(PTCL)

Angioimmunoblastic T-cell lymphoma(AITL)
Peripheral T-cell lymphoma, NOS(PTCL-NOS)
Nodal peripheral T-cell lymphoma with TFH phenotype(nodal PTCL with TFH)
Follicular T-cell lymphoma(FTCL) Cutaneous T-cell lymphoma(CTCL)
Mycosis fungoides(MF)
Sezary syndrome Chronic lymphocytic leukemia/small lymphocytic lymphoma(CLL/SLL)
Relapsed or refractory patients with tumors for which no established standard therapy is available, or refractory or intolerant to existing standard therapy judged by principal investigator or subinvestigator
ECOG PS 0\~2
Life expectancy of at least 3 months