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Набира участници Фаза 3 NCT06549595

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

Фаза 3 – широко изпитване преди одобрение
Заболявания: Untreated Follicular Lymphoma

Спонсор: AstraZeneca

Налично на: БГ
Обобщение
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.
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
Кой може да участва
Inclusion Criteria: 1. Participant must be at least 18 years of age, inclusive, at the time of signing the ICF. 2. Histologically confirmed diagnosis of classic FL per WHO 2022 classification 3. ECOG performance status of 0 to 2 4. No prior systemic lymphoma-directed therapy 5. Need for systemic treatment meeting at least 1 GELF criteria 6. FDG-avid and measurable disease 7. Stage II to IV and FLIPI 2-5 \[Phase III only\] 8. Adequate liver, hematological, renal and cardiac function. The above is a summary, other inclusion criteria details may apply Exclusion Criteria: 1. 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 2. Contra-indication to BR, RCVP, and R-CHOP 3. Participants with or history of CNS lymphoma 4. 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 5. Presence of \>5000 circulating lymphoma cells 6. 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 7. Known history of hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS) The above is a summary, other exclusion criteria details may apply
Места на провеждане 18
Австралия (1)
Research Site
Darlinghurst
NOT_YET_RECRUITING
Белгия (1)
Research Site
Brussels
NOT_YET_RECRUITING
Бразилия (1)
Research Site
Porto Alegre
Канада (1)
Research Site
Winnipeg , Manitoba
NOT_YET_RECRUITING
Китай (1)
Research Site
Beijing
NOT_YET_RECRUITING
Финландия (1)
Research Site
Helsinki
WITHDRAWN
Hong Kong (1)
Research Site
Hong Kong
Унгария (1)
Research Site
Budapest
WITHDRAWN
Индия (1)
Research Site
Delhi
NOT_YET_RECRUITING
Япония (1)
Research Site
Bunkyō City
Полша (1)
Research Site
Gliwice
WITHDRAWN
Южна Корея (1)
Research Site
Busan
Испания (1)
Research Site
Barcelona
NOT_YET_RECRUITING
Швеция (1)
Research Site
Falun
WITHDRAWN
Taiwan (1)
Research Site
Changhua
Тайланд (1)
Research Site
Bangkok
Великобритания (1)
Research Site
London
САЩ (1)
Research Site
Anchorage , Alaska
NOT_YET_RECRUITING
Технически детайли
Статус
Набира участници
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
130 Years
Здрави доброволци
Не
Начална дата
07.08.2024
Крайна дата
26.11.2031
Регистрационен номер
NCT06549595
Източник
anzctr
Запитване за медицински туризъм

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