Orelabrutinib in Combination with R-CHOP for CD5-positive DLBCL Patients（Rocket Trial）

Официальное название

Orelabrutinib in Combination with R-CHOP for CD5-positive DLBCL Patients: a Single-arm, Multicenter, Phase II Clinical Trial（Rocket Trial）

Обзор

This is a prospective, single-arm, multicenter, phase II clinical trial to evaluate the efficacy and safety of orelabrutinib combined with the R-CHOP (rituximab, cyclophosphamide, vincristine, doxorubicin, and prednisone) regimen as first-line treatment in CD5-positive diffuse large B-cell lymphoma (DLBCL) patients.

Подробное описание

The purpose of this phase II clinical trial is to evaluate the efficacy and safety of orelabrutinib in combination with R-CHOP for untreated CD5-positive DLBCL patients.

The induction phase consisted of 6 cycles of orelabrutinib in combination with R-CHOP (orelabrutinib added from the second cycle), followed by 2 cycles of rituximab + orelabrutinib, for a total of 8 treatment cycles. After 8 cycles of induction therapy, if the response is assessed as complete remission (CR), maintenance therapy with orelabrutinib will be conducted.

The primary endpoint is the 2-year event-free survival (EFS) rate.

Вмешательства

• Препарат Orelabrutinib Oral Tablet
  Orelabrutinib (150 mg po D1-D21) is added from the second cycle of R-CHOP regimen
• Препарат R-CHOP Protocol
  Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone

Первичные конечные точки

• 2-year event-free survival (EFS) rate [Срок оценки: Defined as the proportion of patients without disease progression, treatment discontinuation, or death for any reason within 24 months of enrollment]

Вторичные конечные точки (6)

• Complete response rate (CRR) [Срок оценки: Up to 8 cycles (each cycle is 21 days)]
• Disease-free survival (DFS) [Срок оценки: From date of the first complete response until the date of the first documented progression or date of death from any cause, whichever came first, assessed up to 24 months]
• Objective response rate (ORR) [Срок оценки: Up to 8 cycles (each cycle is 21 days)]
• 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]
• Number of participants with adverse events (AE) and severe adverse events (SAE) as assessed by CTCAE v5.0 [Срок оценки: Through study completion, an average of 2 years]

Критерии участия

Критерии включения

• Subjects fully understand and voluntarily participate in this study and sign informed consent.
• Aged ≥18 years, both male and female.
• Pathologically confirmed CD5-positive DLBCL
• There must be at least one measurable or evaluable lesion that meets the evaluation criteria for Lugano 2014 lymphoma.
• Eastern Cooperative Oncology Group(ECOG) performance status score of 0-2.
• Expected survival ≥3 months.
• Sufficient bone marrow, liver, and kidney function.

Критерии исключения

• DLBCL combined with other types of lymphoma. Transformed DLBCL.
• DLBCL with central nervous system invasion.
• The patients had previously received BTK inhibitors.
• The patients have contraindications to any drug in the combined treatment.
• Patients with the infection of human immunodeficiency virus (HIV) and/or acquired immunodeficiency syndrome.
• Inability to swallow tablets, presence of malabsorption syndrome, or any other gastrointestinal disease or dysfunction that may affect the absorption of the study drug.
• Pregnant and lactating women, and subjects of childbearing age who do not want to use contraception.
• Mentally ill persons or persons unable to obtain informed consent.
• The investigators think that the patient is not suitable for the study.

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 · 11 центров

• Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University, — Гуанчжоу
• Gansu Cancer Hospital — Lanzhou
• Dongguan People's Hospital — Дунгуань
• Fifth Affiliated Hospital of Guangzhou Medical University — Гуанчжоу
• First People's Hospital of Guangzhou — Гуанчжоу
• Guangdong Provincial Hospital of Traditional Chinese Medicine — Гуанчжоу
• Second Affiliated Hospital of Guangzhou Medical University — Гуанчжоу
• First Affiliated Hospital of Shantou University Medical College. — Shantou
• … и ещё 3 центра

Идентификаторы

NCT: NCT06647940 · B2024-570-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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