Идёт набор NCT06549595

A Study of Surovatamig (AZD0486) Plus Rituximab in Previously Untreated Follicular Lymphoma Patients

Фаза III С лечением Untreated Follicular 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: Surovatamig, R-CHOP, R-CVP, BR.
Кому может быть актуально: Состояния в реестре: Untreated Follicular Lymphoma. Базовые параметры: 18 лет — 130 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, Австралия, Бельгия, Бразилия, Канада +18
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

A Phase III, Multicentre, Randomised, Open-label Study to Compare the Efficacy and Safety of AZD0486 Plus Rituximab Versus Chemotherapy Plus Rituximab in Previously Untreated Participants With Follicular Lymphoma (SOUNDTRACK-F1)

Обзор

This is a global, randomised, Phase III, multicentre, open-label study evaluating the efficacy, safety and the degree of added benefit of the Surovatamig (AZD0486) plus rituximab combination compared to Investigator's choice of 3 standard immunochemotherapy regimen, conducted in participants with untreated FL.

Подробное описание

The study consists of 2 sequential parts.

1. Safety Run-in - this part will compare dose levels of Surovatamig (AZD0486) in combination with rituximab in order to establish the RP3D. 2. Phase III - The Phase III part will assess the superiority of Surovatamig (AZD0486) at RP3D in combination with rituximab, compared to Investigator's choice between 3 standard chemoimmunotherapy regimens. Phase 3 consists of 3 arms

1. Arm A: treatment with Surovatamig plus rituximab Schedule A 2. Arm B: treatment with Surovatamig plus rituximab Schedule B 3. Arm C (Comparator arm): one of the following standard regimens per Investigator's choice: R-CVP + rituximab maintenance, R-CHOP + rituximab maintenance or B-R + rituximab maintenance

Вмешательства

Препарат Surovatamig
a fully human bispecific monoclonal IgG4 antibody
Препарат R-CHOP
Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
Препарат R-CVP
Rituximab, Cyclophosphamide, Vincristine and Prednisone
Препарат BR
Bendamustine, Rituximab

Первичные конечные точки

SRI Primary: Incidence, nature and severity of AEs and SAEs. Incidence and nature of study drug discontinuations, dose reductions, and dose delays due to AEs [Срок оценки: Up to 10 years]
SRI Primary: Determination of the recommended Phase III dose (RP3D) [Срок оценки: Up to 1 year]
Phase 3 Dual Primary: To demonstrate the superiority of Surovatamig plus rituximab compared to Investigator's choice of SoC chemoimmunotherapy [Срок оценки: Up to 10 years]
Phase 3 Dual Primary: To demonstrate the superiority of Surovatamig plus rituximab compared to Investigator's choice of SoC chemoimmunotherapy [Срок оценки: Up to 10 years]

Вторичные конечные точки (9)

Safety Run in and Phase 3: ORR at EoI (Investigator assessed) [Срок оценки: Up to 10 years]
Safety Run In and Phase 3: CR Rate [Срок оценки: Up to 10 years]
Safety Run In and Phase 3: CR at EoI [Срок оценки: Up to 10 years]
Safety Run In and Phase 3: DoR [Срок оценки: up to 10 years]
Safety Run In and Phase 3: PFS (Investigator assessed) [Срок оценки: Up to 10 years]
Safety Run In and Phase 3: OS [Срок оценки: Up to 10 years]
Phase 3: CR rate at 30 months (CR30) [Срок оценки: Up to 30 months]
Phase 3: Time to First Subsequent Therapy or Death (TFST) [Срок оценки: Up to 10 Years]
Phase 3: Time from randomisation to second progression or death (PFS2) [Срок оценки: Up to 10 Years]

Критерии участия

Критерии включения

Participant must be at least 18 years of age, inclusive, at the time of signing the ICF.
Histologically confirmed diagnosis of classic FL per WHO 2022 classification
ECOG performance status of 0 to 2
No prior systemic lymphoma-directed therapy
Need for systemic treatment meeting at least 1 GELF criteria
FDG-avid and measurable disease
Stage II to IV and FLIPI 2-5 \[Phase III only\]
Adequate liver, hematological, renal and cardiac function.

The above is a summary, other inclusion criteria details may apply

Критерии исключения

Follicular large B-cell lymphoma (WHO 2022 classification), formerly Follicular lymphoma Grade 3B (WHO 2016 classification) or suspicion for histologic transformation to high-grade/aggressive lymphoma
Contra-indication to BR, RCVP, and R-CHOP
Participants with or history of CNS lymphoma
History of a clinically relevant CNS medical condition or pathology that required treatment in the preceding year, is currently symptomatic or that which the treating investigator considers to have the potential to interfere with the evaluation of safety
Presence of >5000 circulating lymphoma cells
Active or uncontrolled infection (including EBV) requiring systemic therapy and which places participant at unacceptable risk if he/she were to participate in the study. If a participant has a history of COVID-19 within 1 month of C1D1 or contracts COVID while on study treatment, participant must have 2 consecutive negative tests (PCR testing is preferable) performed at least 48 hours apart prior to resuming dosing. All symptoms related to COVID-19 infection should have fully resolved before initiating or resuming treatment
Known history of hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS)

The above is a summary, other exclusion criteria details may apply

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 · 55 центров

Research Site — Huntsville
Research Site — Anchorage
Research Site — Phoenix
Research Site — Clovis
Research Site — Los Alamitos
Research Site — San Diego
Research Site — Santa Monica
Research Site — Aurora
… и ещё 47 центров

Китай · 34 центра

Research Site — Пекин
Research Site — Пекин
… и ещё 32 центра

Япония · 19 центров