AZD0486 1L Therapy for Elderly or Unfit Participants With LBCL

Официальное название

A Phase III, Multicentre, Open-Label, Randomised Study Evaluating the Efficacy and Safety of R-mini-CHOP x2 Followed by AZD0486 Versus R-mini-CHOP x6 in Elderly or Unfit Participants With Newly Diagnosed Large B-cell Lymphoma (SOUNDTRACK-D2)

Обзор

The purpose of this study is to measure the efficacy and safety of R-mini-CHOP × 2 followed by AZD0486 compared with R-mini-CHOP × 6 in elderly or unfit participants newly diagnosed with LBCL.

Вмешательства

• Препарат AZD0486
  Bispecific monoclonal IgG4 antibody
• Препарат R-mini-CHOP
  Intravenous administration: Rituximab 375 mg/m2, Cyclophosphamide 400 mg/m2, Doxorubicin 25 mg/m2, Vincristine 1 mg, and Oral administration: Prednisone 40 mg/m2

Первичные конечные точки

• SRI - Safety evaluation of R-mini-CHOP × 2 followed by AZD0486: Number of participants with treatment-related adverse events. [Срок оценки: Up to 1 year]
• SRI - Tolerability evaluation of R-mini-CHOP × 2 followed by AZD0486: Number of participants with treatment-related adverse events. [Срок оценки: Up to 1 year]
• SRI - Determination of the recommended Phase III dose (RP3D) [Срок оценки: Up to 1 year]
• Phase 3 - To demonstrate the superiority of R-mini-CHOP x2 followed by AZD0486 compared to R-mini-CHOP x6 regimen. [Срок оценки: Up to 7 years]

Вторичные конечные точки (12)

• Safety Run-In and Phase 3 - ORR [Срок оценки: Up to 7 years]
• Safety Run-In and Phase 3 - CR Rate [Срок оценки: Up to 7 years]
• Safety Run-In and Phase 3 - DoR [Срок оценки: Up to 7 years]
• Safety Run-In and Phase 3 - DoCR [Срок оценки: Up to 7 years]
• Safety Run-In and Phase 3 - PFS [Срок оценки: Up to 7 years]
• Safety Run In and Phase 3 - OS [Срок оценки: Up to 7 years]
• Phase 3 - Time from randomisation to second progression or death (PFS2) [Срок оценки: Up to 7 years]
• Phase 3 - Time to First Subsequent Therapy or Death (TFST) [Срок оценки: Up to 7 Years]
• Phase 3 - Safety evaluation of R-mini-CHOP × 2 followed by AZD0486: Number of participants with treatment-related adverse events. [Срок оценки: Up to 7 years]
• Phase 3 - Tolerability evaluation of R-mini-CHOP × 2 followed by AZD0486: Number of participants with treatment-related adverse events. [Срок оценки: Up to 7 years]
• Safety Run-In and Phase 3 - Pharmacokinetics of AZD0486: serum concentration of study drug [Срок оценки: Up to 7 years]
• Safety Run-In and Phase 3 - Pharmacokinetics of AZD0486: Maximum plasma concentration of the study drug (Cmax). [Срок оценки: Up to 7 years]

Критерии участия

Критерии включения

• Participants are either 80 years of age or older, OR 65 to 79 years of age or older and classified as unfit per sGA, and otherwise not considered candidates for full-dose R-CHOP per investigator assessment;
• Histologically confirmed diagnosis of previously untreated LBCL as per WHO-HEM5 (excluding plasmablastic lymphoma) and follicular large cell lymphoma;
• FDG-avid and measurable disease as per Lugano and Ann Arbor staging;
• Stage I bulky (7.5 cm and greater) to Stage IV;
• ECOG performance status 0 to 2;
• Adequate bone marrow, liver, renal and cardiac function.

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

• As judged by the investigator, any evidence of diseases which make it undesirable for the participant to participate in the study, or that would jeopardise compliance with the protocol
• Diagnosis of post-transplant lymphoproliferative disease, plasmablastic lymphoma, Richter's transformation, prior history of or concurrent indolent lymphoma (including de novo transformed or composite lymphoma).
• History of CNS involvement by their B-NHL or history of clinically relevant CNS medical condition
• Known history of hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS).
• Active or uncontrolled infection
• Major cardiac abnormalities
• Prior anti-lymphoma therapy except for corticosteroids for symptom control
• Requires chronic immunosuppressive therapy for active autoimmune/inflammatory condition, with some exceptions

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

Китай · 18 центров

• Research Site — Пекин
• Research Site — Changchun
• Research Site — Чэнду
• Research Site — Чунцин
• Research Site — Фучжоу
• Research Site — Гуанчжоу
• Research Site — Гуанчжоу
• Research Site — Haikou
• … и ещё 10 центров

Япония · 17 центров

• Research Site — Akashi
• Research Site — Bunkyō City
• Research Site — Himeji-shi
• Research Site — Kōtoku
• Research Site — Kumamoto
• Research Site — Matsumoto-shi
• Research Site — Matsuyama
• Research Site — Meguro-ku
• … и ещё 9 центров

Бельгия · 6 центров

• Research Site — Antwerp
• Research Site — Brussels
• Research Site — Ghent
• Research Site — Leuven
• Research Site — Roeselare
• Research Site — Yvoir

Австралия · 5 центров

• Research Site — Clayton
• Research Site — Macquarie University
• Research Site — Melbourne
• Research Site — Nedlands
• Research Site — Waratah

Польша · 5 центров

• Research Site — Kielce
• Research Site — Krakow
• Research Site — Lodz
• Research Site — Lublin
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Канада · 4 центра

• Research Site — Calgary
• Research Site — Victoria
• Research Site — Hamilton
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Великобритания · 4 центра

• Research Site — Glasgow, Scotland
• Research Site — London
• Research Site — Newcastle upon Tyne
• Research Site — Nottingham

Гонконг · 3 центра

• Research Site — Гонконг
• Research Site — Lai Chi Kok
• Research Site — Shatin

Бразилия · 2 центра

• Research Site — Porto Alegre
• Research Site — São Paulo

South Korea · 2 центра

• Research Site — Seoul
• Research Site — Seoul

Turkey (Türkiye) · 2 центра

• Research Site — Ankara
• Research Site — Antalya

Идентификаторы

NCT: NCT07215585 · D7402C00001 · 2025-522029-37-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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