A Exploratory Study on Untreated Follicular Lymphoma With Orelabrutinib, Tafasitamab, and Lenalidomide

Официальное название

A Multicenter Exploratory Clinical Study on the Treatment of Untreated Follicular Lymphoma With Orelabrutinib, Tafasitamab, and Lenalidomide

Обзор

Evaluate the efficacy and safety of orelabrutinib, tafasitamab, and lenalidomide in the first-line treatment of patients with follicular lymphoma.

Подробное описание

Follicular lymphoma (FL) is the most common indolent non-Hodgkin's lymphoma (NHL), accounting for 35% of NHL cases . The median age at diagnosis is 65 years , and most patients are diagnosed at an advanced stage. Although FL is still considered incurable, the clinical prognosis for most patients remains favorable.Currently, there is some data available for BTKi and tafasitamab in relapsed/refractory follicular lymphoma, and further exploration of relevant data in the first-line setting is needed. This combination therapy may provide new options for patients with follicular lymphoma.

Вмешательства

• Препарат Orelabrutinib
  Orelabrutinib 150 mg orally once daily on Days 1-28 of each 28-day cycle during induction therapy and maintenance therapy.
• Препарат Tafasitamab
  Tafasitamab 12 mg/kg administered by intravenous infusion on Days 1, 4, 8, 15, and 22 in Cycle 1; on Days 1, 8, 15, and 22 in Cycles 2-3; and on Days 1 and 15 from Cycle 4 onward during induction therapy.
• Препарат Lenalidomide
  Lenalidomide 20 mg orally once daily on Days 1-21 of each 28-day cycle during induction therapy and 10 mg orally once daily on Days 1-21 of each 28-day cycle during maintenance therapy.

Первичные конечные точки

• Objective Response Rate (ORR) [Срок оценки: At the end of cycle 12 (each cycle is 28 days; up to approximately 48 weeks)]

Вторичные конечные точки (5)

• Complete Response (CR) Rate [Срок оценки: At the end of cycle 12 (each cycle is 28 days; up to approximately 48 weeks)]
• Progression-Free Survival (PFS) [Срок оценки: Up to approximately 3 years]
• Rate of Progression of Disease within 24 Months (POD24) [Срок оценки: 24 months]
• Incidence and Severity of Adverse Events (AEs) [Срок оценки: Up to approximately 3 years]
• Overall Survival (OS) [Срок оценки: Up to approximately 3 years]

Критерии участия

Критерии включения

• Age > 18 years, regardless of gender;
• Newly diagnosed patients with follicular lymphoma (Grade 1, 2, or 3a) confirmed histologicallyaccording to the World Health Organization (WHO) classification of diseases;
• Deemed by the investigator to have an indication for treatment and require therapy;
• ECOG performance status score of 0-2;
• Laboratory tests meeting the following criteria:

• Bone marrow hematopoietic function is essentially normal: WBC 3.5x10\^9/L, ANC > 1.0x10\^9/L, PLT > 75x10\^9/L, Hb > 80 g/L;
• Liver function: AST/ALT s 2xULN, TBILI s 2xULN;
• Renal function: Creatinine clearance rate > 50 ml/min;6. Presence of at least one measurable lesion: Lymph node lesion with a long diameter > 1.5 cm orextranodal lesion with a long diameter > 1.0 cm as shown by PET/CT, CT, or MRl, or a lesion > 2cm assessed by clinical examination;

7\. Ability to provide written informed consent.

Критерии исключения

• Women with a positive serum pregnancy test or who are breastfeeding;
• Patients with lymphoma involving the central nervous system (CNS);
• Clinically significant heart disease, including unstable angina, acute myocardial infarction within6 months prior to randomization, congestive heart failure with New York Heart Association(NYHA) functional class IIl or IV, or left ventricular ejection fraction <50%;
• Patients with grade >2 neuropathy;
• Patients with active hepatitis B (HBV, hepatitis C (HCV, or other acquired/congenitalimmunodeficiency diseases;
• Patients with severe active infections requiring systemic antibiotic treatment;
• Patients with a history of severe neurological or psychiatric disorders that impair trialparticipation, including dementia, epilepsy, severe depression, and mania;8. Drug abuse, or medical, psychological, or social conditions that may interfere with studyparticipation or result evaluation;

9\. Patients deemed ineligible 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 · 5 центров

• Shenzhen Second People's Hospital — Шэньчжэнь
• Henan Cancer Hospital — Чжэнчжоу
• The First Affiliated Hospital of Nanchang University — Nanchang
• Qilu Hospital of Shandong Province — Цзинань
• Institute of Hematology & Blood Diseases Hospital, China — Тяньцзинь

Идентификаторы

NCT: NCT07585747 · IIT2026026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗