Идёт набор NCT03557619

A Study to Assess the Effect of Venetoclax on Ethinyl Estradiol and Levonorgestrel in Female Participants With Different Hematological Malignancies

Фаза I С лечением Hematologic Malignancies

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: Venetoclax, ethinyl estradiol/levonorgestrel.
Кому может быть актуально: Состояния в реестре: Hematologic Malignancies. Базовые параметры: от 18 лет · Женщины.
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, Австралия
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 Study to Assess the Effect of Venetoclax on the Pharmacokinetics of Ethinyl Estradiol/Levonorgestrel in Female Subjects With Hematologic Malignancies

Обзор

A study to assess the effect of multiple doses of venetoclax on the pharmacokinetics of ethinyl estradiol and levonorgestrel in female participants with different hematological malignancies. Upon completion of this study, participants receiving clinical benefit in the opinion of the investigator and without any clinically significant evidence of disease progression with no access to venetoclax (not approved for the treated indication) may continue receiving venetoclax at the discretion of the investigator in a separate extension study.

Вмешательства

Препарат Venetoclax
tablet; oral
Препарат ethinyl estradiol/levonorgestrel
tablet; oral

Первичные конечные точки

Tmax of Venetoclax [Срок оценки: Up to approximately 59 days after initial study drug dose]
Tmax of (ethinyl estradiol) EE/Levonorgestrel [Срок оценки: Up to approximately 59 days after initial study drug dose]
Cmax of Venetoclax [Срок оценки: Up to approximately 59 days after initial study drug dose]
Cmax of EE/Levonorgestrel [Срок оценки: Up to approximately 59 days after initial study drug dose]
t1/2 of Venetoclax [Срок оценки: Up to approximately 59 days after initial study drug dose]
t1/2 of EE/Levonorgestrel [Срок оценки: Up to approximately 59 days after initial study drug dose]
AUCt of Venetoclax [Срок оценки: Up to approximately 59 days after initial study drug dose]
AUCt of EE/Levonorgestrel [Срок оценки: Up to approximately 59 days after initial study drug dose]
AUCinf of EE/Levonorgestrel [Срок оценки: Up to approximately 59 days after initial study drug dose]

Критерии участия

Критерии включения

Participant must have relapsed or refractory non-Hodgkin's lymphoma (NHL).
Participant must have histologically documented diagnosis of one of the following NHL subtypes: diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), lymphoplasmacytic lymphoma (LPL), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), T-cell prolymphocytic lymphoma (T-PLL), Waldenström's macroglobulinemia (WM)
Has an Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to two.
Must have adequate bone marrow, coagulation, renal and hepatic function as described in the protocol.
A female of non-childbearing potential as described in the protocol.

Критерии исключения

History of currently active, clinically significant cardiovascular disease.
If the participant has had prior stem cell transplantation, it must have been more than 100 days prior to start of study drug, with no graft versus host disease, and no immunosuppression therapy.
evidence of transformation of the lymphoma immediately prior to study entry.
Evidence of central nervous system involvement by lymphoma.

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

Здоровые добровольцы: Нет