Rituximab, Lenalidomide Combined With Methotrexate and Temozolomide For Primary Central Nervous System Lymphoma

Официальное название

A Single Arm, Multi-center, Phase II Clinical Trial of Rituximab, Lenalidomide Combined With High-dose Methotrexate and Temozolomide (RL-MT) in the First-line Treatment for Patients With Primary Central Nervous System Lymphoma

Обзор

This is a prospective single arm, multi-center, phase II clinical trial to observe the efficacy and safety of Rituximab, Lenalidomide combined with high-dose Methotrexate and Temozolomide (RL-MT) in the first-line treatment for patients with primary central nervous system lymphoma.

Вмешательства

• Препарат Rituximab
  Induction Chemotherapy: 375mg/m2, Intravenous administration on day 0 of each 3-week cycle until disease progression/stable disease or unacceptable toxicity develops, up to 6 cycles.
• Препарат Lenalidomide
  Induction Chemotherapy: 25mg, oral administration on day 1 to 10 of each 3-week cycle until disease progression/stable disease or unacceptable toxicity develops, up to 6 cycles. Maintenance Treatment: 10mg oral administration on day 1 to 21 repeated every 4 weeks until disease progression or unacceptable toxicity develops, up to 12 cycles.
• Препарат Methotrexate
  Induction Chemotherapy: 3mg/m2, Intravenous administration (pumping for 3h) on day 1 of each 3-week cycle until disease progression/stable disease or unacceptable toxicity develops, up to 6 cycles.
• Препарат Temozolomide
  Induction Chemotherapy: 150mg/m2/d oral administration on day 1 to 10 of each 3-week cycle until disease progression/stable disease or unacceptable toxicity develops, up to 6 cycles.

Первичные конечные точки

• 2-year progression-free survival [Срок оценки: from the day of the first cycle of treatment to the date of confirmed progressive disease or death, whichever occurs first, up to 2 years after last patient's enrollment (each cycle is 21 days)]

Вторичные конечные точки (3)

• objective response rate [Срок оценки: every 6 weeks from the day of the first cycle of induction chemotherapy treatment and every 8 weeks from the day of the first cycle of maintenance treatment to 18 months after last patient's enrollment (each cycle is 21 days)]
• overall survival [Срок оценки: from date of the first cycle of treatment to the date of death from any cause, assessed up to 5 years (each cycle is 21 days)]
• incidence and relationship with study drugs of grade 3-4 adverse events [Срок оценки: from the date of the first cycle of treatment to 18 months after last patient's enrollment (each cycle is 21 days)]

Критерии участия

Критерии включения

• Age between 18 to 70 years old (including 18 and 70)
• Diagnosed as primary central nervous system lymphoma (limited to the brain, spinal cord, meninges and eyeballs, without involvement of other parts)
• Having not received anti-tumor therapy before enrollment (except for tumor resection and biopsy and the use of glucocorticoids to reduce central nervous system symptoms)
• Having at least one measurable lesions
• World health organization-Eastern Cooperative Oncology Group Performance Status (ECOG) 0-2 ( ECOG 3 due to tumors can be included after being fully assessed by the investigator)
• Life expectancy no less than 1 month
• enough main organ function
• Pregnancy test within 7 days must be negative for women of childbearing period, and appropriate measures should be taken for contraception for women in childbearing period during the study and six months after this study
• Agreeing to sign the written informed consents

Критерии исключения

• Diagnosed as secondary central nervous system lymphoma
• Diagnosed as CD20 negative large B cell primary central nervous system lymphoma
• Active malignant tumor need be treated at the same time
• Other malignant tumor history
• Serious surgery and trauma less than two weeks
• Patients with active tuberculosis
• Systemic therapy for serious acute/chronic infection
• Congestive heart failure, uncontrolled coronary heart disease, arrhythmia and heart infarction less than 6 months
• HIV-positive, AIDS patients and untreated active hepatitis
• Patients with a history of deep vein thrombosis or pulmonary embolism less than 12 months
• Patients with a history of mental illness or drug abuse
• Poor compliance during the trial and/or follow-up phase
• Allergies or people who are known to be allergic to any active ingredients, excipients, mouse-derived products or heterologous protein contained in this trial
• Researchers determine unsuited to participate in this trial

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

• Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university — Чжэнчжоу

Идентификаторы

NCT: NCT04737889 · HNSZLYYNHL04

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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