Идёт набор NCT06890884

A Clinical Study of Zilovertamab Vedotin (MK-2140) Plus Rituximab Plus Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Polatuzumab Vedotin Plus R-CHP in People With Diffuse Large B-cell Lymphoma (DLBCL) (MK-2140-011/waveLINE-011)

Фаза II С лечением Lymphoma, Large B-Cell, Diffuse

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: Zilovertamab vedotin, Rituximab, Cyclophosphamide, Doxorubicin.
Кому может быть актуально: Состояния в реестре: Lymphoma, Large B-Cell, Diffuse. 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, Бельгия, Германия, Ирландия, Израиль +4
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 Randomized, Open-label, Multicenter, Phase 2 Study Evaluating the Efficacy and Safety of Zilovertamab Vedotin (MK-2140) Plus R-CHP Versus Polatuzumab Vedotin Plus R-CHP in Treatment-naïve Participants With GCB Subtype of Diffuse Large B-cell Lymphoma (DLBCL)

Обзор

Researchers are looking for ways to treat germinal center B-cell-like diffuse large B-cell lymphoma (GCB DLBCL). DLBCL is a fast-growing blood cancer that affects B-cells. GCB is a type of DLBCL that affects young B-cells that are still maturing. The goal of this study is to learn if more people who receive zilovertamab vedotin (MK-2140) and R-CHP have the cancer respond (go away) than those who receive polatuzumab vedotin and R-CHP.

Вмешательства

Биопрепарат Zilovertamab vedotin
IV infusion
Биопрепарат Rituximab
IV infusion
Препарат Cyclophosphamide
IV infusion
Препарат Doxorubicin
IV infusion
Биопрепарат Rituximab Biosimilar
IV infusion
Препарат Prednisone
Oral administration or IV infusion
Препарат Prednisolone
Oral administration or IV infusion
Биопрепарат Polatuzumab vedotin
IV infusion
Препарат Rescue Medication
Participants receive rescue medication at the investigators discretion, per approved product label. Recommended rescue medication is Granulocyte Colony-Stimulating Factor (G-CSF).

Первичные конечные точки

Complete Response Rate (CRR) at End of Treatment (EOT) per Lugano Response Criteria [Срок оценки: Up to approximately 31 months]

Вторичные конечные точки (10)

Progression-free Survival (PFS) per Lugano Response Criteria [Срок оценки: Up to approximately 51 months]
Overall Survival (OS) [Срок оценки: Up to approximately 87 months]
Event-free Survival (EFS) per Lugano Response Criteria [Срок оценки: Up to approximately 51 months]
Duration of CR [Срок оценки: Up to approximately 51 months]
Number of participants who experience one or more adverse events (AEs) [Срок оценки: Up to approximately 9 months]
Number of participants who discontinue study intervention due to an AE [Срок оценки: Up to approximately 6 months]
Change From Baseline in Health-Related Quality Of Life (HRQoL) on Functional Assessment of Cancer Therapy Lymphoma (FACT-Lym) Trial Outcome Index (TOI) [Срок оценки: Baseline and up to Week 25]
Change From Baseline in HRQoL on FACT-Lym Total Score [Срок оценки: Baseline and up to Week 25]
Change From Baseline in HRQoL on FACT-Lym Physical Well-being (PWB) (Items General Physical [GP]1 through GP7) [Срок оценки: Baseline and up to Week 25]
Change From Baseline in HRQoL on Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-NTX) Neurotoxicity Subscale Score [Срок оценки: Baseline and up to Week 25]

Критерии участия

Критерии включения

The main inclusion criteria include but are not limited to the following:

Has histologically confirmed diagnosis of germinal center B-cell (GCB) subtype of diffuse large B-cell lymphoma (DLBCL), by prior biopsy, according to the World Health Organization (WHO) classification of neoplasms of the hematopoietic and lymphoid tissues.
Has positron emission tomography (PET) positive disease at screening, defined as 4 to 5 on the Lugano 5-point scale.
Has received no prior treatment for their DLBCL.
Human immunodeficiency virus (HIV) infected participants must have well controlled HIV on antiretroviral therapy (ART).
Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy and have undetectable HBV viral load prior to randomization.
Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening.

Критерии исключения

The main exclusion criteria include but are not limited to the following:

Has a history of transformation of indolent disease to DLBCL.
Has received a diagnosis of primary mediastinal B-cell lymphoma (PMBCL) or Grey zone lymphoma.
Has Ann Arbor Stage I DLBCL.
Has clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (<6 months prior to enrollment), myocardial infarction (<6 months prior to enrollment), unstable angina, congestive heart failure (New York Heart Association Classification Class ≥II), or serious cardiac arrhythmia requiring medication.
Has clinically significant pericardial or pleural effusion.
Has ongoing Grade >1 peripheral neuropathy.
Has a demyelinating form of Charcot-Marie-Tooth disease.
HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
Has ongoing corticosteroid therapy.
Known additional malignancy that is progressing or has required active treatment within the past 2 years.
Known active central nervous system (CNS) lymphoma.
Has active autoimmune disease that has required systemic treatment in the past 2 years.
Has active infection requiring systemic therapy.
Has active HBV (defined as HBsAg positive and detectable HBV deoxyribonucleic acid (DNA)) and HCV (defined as anti-HCV antibody positive and detectable HCV ribonucleic acid (RNA)) infection.
Has history of stem cell/solid organ transplant.

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

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