A Study of Rocbrutinib in Participants With Relapse or Refractory Non-GCB Diffuse Large B-Cell Lymphoma

Официальное название

An Open-Label, Randomized Controlled, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of Rocbrutinib Monotherapy Versus Investigator's Choice of Therapy in Patients With Relapsed or Refractory Non-GCB Diffuse Large B-Cell Lymphoma

Обзор

This is an open-label, randomized controlled, multicenter Phase II clinical study primarily evaluating the efficacy and safety of Rocbrutinib monotherapy compared to the investigator's choice of BR/R2 regimen in patients with non-GCB DLBCL.

Вмешательства

• Препарат Rocbrutinib
  200mg qd PO. The treatment will continue until progressive disease, unacceptable toxicity, etc.
• Препарат Bendamustine
  Participants will receive a total of 6 cycles (a cycle being 28 days) 90 mg/m2 Bendamustine (IV infusion) on Days 1 and 2 of Cycles 1-6.
• Препарат Rituximab
  Participants will receive a total of 6 cycles (a cycle being 28 days) of 375 mg/m2 Rituximab (IV infusion) on Day 1 of each cycle.
• Препарат Lenalidomide
  20mg qd PO day 1-21

Первичные конечные точки

• Overall Response Rate [Срок оценки: Up to 24 Months]

Вторичные конечные точки (7)

• Overall Response Rate [Срок оценки: Up to 24 Months]
• Complete remission rate [Срок оценки: Up to 24 Months]
• Progression Free Survival [Срок оценки: Up to 24 months]
• Overall survival [Срок оценки: Measured from the date of date of first dose to the date of death or last visit, and for up to 5 years after the last subject is enrolled.]
• Duration of Response (DOR) [Срок оценки: Up to 24 months]
• Time to Response (TTR) [Срок оценки: Measured from the date of the first dose of study drug to the date of earliest response, and assessed up to 6 months.]
• Safety Assessment [Срок оценки: From first dose of study drug to 28 days after last dose of study drug]

Критерии участия

Критерии включения

• Age ≥18 years, any gender.
• Pathologically confirmed DLBCL (not otherwise specified) according to the revised 2017 WHO classification of lymphoid neoplasms, with non-germinal center B-cell-like (non-GCB) subtype confirmed by Han's algorithm (Appendix 1), based on previous pathological records or confirmed during screening. Must be able to provide sufficient tumor tissue or slides (from previous or screening biopsies) for central laboratory confirmation of pathological diagnosis (if the local pathology report is clear, patients may be enrolled and start treatment without waiting for the central pathology report).
• Patients who are refractory or have relapsed after at least two prior lines of therapy (at least one line must include an anti-CD20 antibody-containing regimen) (see section 6.3 for definition of refractory or relapsed).
• At least one measurable lesion (nodal lesion with longest diameter >1.5 cm, extranodal lesion with longest diameter >1.0 cm).
• Not planned for autologous stem cell transplantation (ASCT).
• Eastern Cooperative Oncology Group (ECOG) performance status score ≤2.

Критерии исключения

• Primary central nervous system (CNS) lymphoma or known involvement of lymphoma in the CNS (including patients whose CNS lymphoma is currently in complete remission).
• DLBCL resulting from histological transformation of an previously diagnosed indolent lymphoma \[such as follicular lymphoma (FL), marginal zone lymphoma, chronic lymphocytic leukemia, etc.\] or pathological findings suggesting concomitant FL (any grade).
• Diagnosis of other types of large B-cell lymphoma or special types of DLBCL, including but not limited to high-grade B-cell lymphoma, EBV-positive DLBCL, T-cell/histiocyte-rich large B-cell lymphoma, primary mediastinal large B-cell lymphoma, etc.
• Previous exposure to Lobertinib or known allergy to any excipient of Lobertinib (including microcrystalline cellulose, croscarmellose sodium, magnesium stearate, fumaric acid, and gastric-soluble film coating premix); allergy or intolerance to Rituximab or any of its excipients; allergy or intolerance to both Bendamustine and Lenalidomide or any of their excipients.
• Previous refractoriness to BTK-targeting drugs.
• Patients who have received autologous stem cell transplantation within 90 days prior to randomization; patients who have received allogeneic stem cell transplantation.

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 · 41 центр

• Anhui Cancer Hospital (West Branch of Anhui Provincial Hospital) — Хэфэй
• Beijing Shijitan Hospital — Пекин
• Beijing Tongren Hospital — Пекин
• National Cancer Center/Chinese Academy of Medical Sciences — Пекин
• Peking University Third Hospital — Пекин
• The First Affiliated Hospital of Chongqing Medical University — Чунцин
• Fujian Cancer Hospital — Фучжоу
• Affiliated Cancer Hospital of Guangzhou Medical University — Гуанчжоу
• … и ещё 33 центра

Идентификаторы

NCT: NCT07189065 · LP-168-CN203

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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