Golidocitinib Plus Anthracycline-based Therapy for Untreated Nodal T-follicular Helper (TFH) Cell Lymphoma

Официальное название

A Phase II, Prospective, Single-Arm Clinical Trial Evaluating the Safety and Efficacy of Golidocitinib Combined With an Anthracycline-Based Regimen as First-Line Treatment for Patients With Nodal T-follicular Helper (TFH) Cell Lymphoma

Обзор

This is a prospective, multicenter, open-label, single-arm, phase II clinical study to evaluate the safety and efficacy of golidocitinib in combination with an anthracycline-based regimen as first-line treatment for patients with previously untreated nodal T-follicular helper (TFH) cell lymphoma.

Вмешательства

• Препарат Golidocitinib
  150mg, po, qd
• Препарат Doxorubicin
  50 mg/m² intravenously on Day 1 of each 21-day cycle
• Препарат Epirubicin
  60-90 mg/m² intravenously on Day 1 of each 21-day cycle

Первичные конечные точки

• Complete response rate [Срок оценки: Up to 6 cycles (each cycle is 21 days)]

Вторичные конечные точки (5)

• Progression-free survival(PFS) [Срок оценки: From the date of enrollment until the date of the first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.]
• Overall survival(OS) [Срок оценки: From the date of enrollment until the date of death from ant cause, assessed up to 24 months]
• Objective response rate (ORR) [Срок оценки: Up to 6 cycles (each cycle is 21 days)]
• Duration of Response(DOR) [Срок оценки: The time from the patient's first efficacy assessment achieving CR or PR until disease progression, assessed up to 24 months]
• Adverse events [Срок оценки: Up to 28 days after the last dose of study treatment]

Критерии участия

Критерии включения

• Histologically confirmed nodal T-follicular helper (TFH) cell lymphoma according to the 2022 WHO classification.
• Previously untreated with systemic anti-lymphoma therapy.
• Age ≥18 and <75 years.
• At least one measurable or evaluable lesion according to the Lugano 2014 criteria.
• An expected survival time of more than 12 weeks.
• An ECOG performance status score of 0-1.
• Adequate organ and bone marrow function.
• Provision of written informed consent and willingness to comply with all study procedures.

Критерии исключения

• Hemophagocytic syndrome.
• Central nervous system or meningeal involvement by lymphoma.
• Patients with a history of other malignancies within the past 5 years or concurrent malignancies, except for basal cell carcinoma of the skin.
• Patients receiving potent CYP3A inducers or inhibitors, vitamin K antagonists, antiplatelet agents, or anticoagulants.
• Patients with active infections, including tuberculosis, HIV infection, active hepatitis B, or active hepatitis C.
• Patients with severe or uncontrolled cardiovascular disease.
• Patients with a history of interstitial lung disease, except for asymptomatic radiation-induced interstitial lung disease.
• Patients with gastrointestinal conditions that may interfere with oral administration or drug absorption.
• Patients with known hypersensitivity to golidocitinib or its excipients.
• Pregnant or breastfeeding women and participants of childbearing potential unwilling to use effective contraception.
• Patients who have received systemic corticosteroids or other immunosuppressive therapy within 14 days before the start of study treatment.
• Patients considered unsuitable for participation by the investigator.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University — Гуанчжоу

Идентификаторы

NCT: NCT07753642 · B2026-455

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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