Comparison of AVD + Low-Dose Nivolumab vs. PET-Adapted BEACOPP-like in Advanced cHL

Официальное название

Randomized Study Comparing AVD Combined With Fixed-Dose Nivolumab Versus PET-Adapted BEACOPP-like Regimen as First-Line Treatment in Advanced Classical Hodgkin Lymphoma

Обзор

Patients in this prospective multicenter phase II study will be randomized between two first-line therapy strategies for advanced stages of cHL. In the Nivo-AVD cohort, patients will receive 2 cycles of nivolumab monotherapy followed by a switch to Nivo-AVD combination therapy (total of 6 cycles); in the Standard cohort, patients will receive therapy according to current clinical guidelines in Russian Federation for first-line therapy of cHL, which include starting first-line therapy with 2 cycles of BEACOPP-like regimens and, after assessing response after 2 courses, switching to A(B)VD or continuing with BEACOPP-like regimens

Вмешательства

• Препарат Nivo-AVD
  1. Monotherapy phase - Nivolumab - 40 mg every 14 days x 2 cycles 2. Combination therapy phase - Nivo-AVD x 6 cycles Nivolumab - 40 mg every 14 days; Doxorubicin 25 mg/m2 in D1 and 15; Vinblastine 6 mg/m2 (no more than 10 mg) in D 1 and 15; Dacarbazine 375 mg/m2 in D 1 and 15;
• Препарат BEACOPP-like
  * BEACOPP-like regimens x 2 cycles + BEACOPP-like regimens x 4 (for patients with PR, SD by PET/CT after 2 cycles) * BEACOPP-like regimens x 2 + A(B)VD x 4 cycles (for patients with CR by PET/CT after 2 cycles)

Первичные конечные точки

• Incidence of adverse events [Срок оценки: Up to 24 months from thetreatment start]

Вторичные конечные точки (3)

• Progression-free survival [Срок оценки: 12, 24 and 36 months after completion of therapy]
• Response rates [Срок оценки: after 2 cycles of nivo and 2 cycles of Nivo-AVD (3 months from therapy initiation) and at the end of treatment (7 months from therapy initiation) and, in Standard cohorts, after 2 cycles and EOT of BEACOPPesc (2 and 6 months)]
• Overall survival [Срок оценки: 12, 24, and 36 months after completion of therapy]

Критерии участия

Критерии включения

• Patients with newly diagnosed histologically confirmed stage IIB, III or IV classical hodgkin lymphoma who have not previously received specific therapy;
• Patients with evidence of lesion extent assessed by whole-body PET/CT;
• Patients aged 18-60 years;
• ECOG 0-2;
• Use of highly effective contraceptive methods from the moment of signing the informed consent form, throughout the study and within 6 months after receiving the last dose of the drug;

Критерии исключения

• Severe organ failure: creatinine > 2 norms; alanine aminotransferase, aspartate aminotransferase > 5 norms; bilirubin> 1.5 norms;
• Respiratory failure > grade 1 at the time of enrollment
• Requirement for vasopressor support at the time of enrollment
• Uncontrolled bacterial or fungal infection at the time of enrollment
• Active or prior documented autoimmune disease requiring systemic treatment
• Pregnancy, breastfeeding, planning pregnancy or parenthood during the study period
• Hypersensitivity or allergy to study drugs
• Somatic or mental pathology that does not allow to perform research procedures, including the signing of informed consent
• Simultaneous use of drugs or medical devices studied in other clinical trials

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

Россия · 3 центра

• A.N.Bakulev Center for cardiovascular surgery of the Russian Ministry of Health — Moscow
• National Medical and Surgical Center named after N.I. Pirogov — Moscow
• St. Petersburg State Pavlov Medical University — Saint Petersburg

Идентификаторы

NCT: NCT07234487 · 28/24-н

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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