The Safety and Effectiveness of 4R-CHOP+4R vs 6R-CHOP+2R in Newly Diagnosed Patients With DLBCL in Low Risk

Официальное название

The Safety and Effectiveness of Four Courses of R-CHOP Plus Four Courses of Rituximab Versus Six Courses of R-CHOP Plus Two Courses of Rituximab in the Treatment of Naive, Low-risk, Non-mass Diffuse Large B-cell Lymphoma: a Multi-center, Prospective, Randomized Controlled Study

Обзор

The Safety and Effectiveness of Four Courses of R-CHOP Plus Four Courses of Rituximab Versus Six Courses of R-CHOP Plus Two Courses of Rituximab in the Treatment of Naive, Low-risk, Non-mass Diffuse Large B-cell Lymphoma: a Multi-center, Prospective, Randomized Controlled Study

Подробное описание

Diffuse large B cell lymphoma (DLBCL) is the subtype with the highest incidence, accounting for 35.8% of B cell lymphoma. 6 to 8 cycles of R-CHOP regimen is currently the standard first-line regimen for DLBCL, however, the side effects including nausea, vomiting, neutropenia, hair loss, and heart failure can decrease the life quality and are sometimes life threatening. Recently, domestic and foreign scholars have been committed to reduce the dose of chemotherapy and improve the quality of life in low-risk patients. This study uses 4 courses of R-CHOP plus 4 courses of R (4+4 plan) versus 6 courses of R-CHOP plus 2 courses of R (6+2 plan) for the treatment of newly treated, low-risk, non-mass DLBCL patients. The promising result will create a new model for the treatment and improve the life quality of low-risk DLBCL.

Вмешательства

• Препарат Six Courses of R-CHOP Plus Two Courses of Rituximab
  The patients will be given RCHOP (Rituximab 375mg/m2 ivgtt, D0, Cyclophosphamide 750mg/m2, ivgtt D1, doxorubicin 50mg/m2,ivgtt D1, Vincristine 1.4mg/m2（max 2mg）, ivgtt D1 Prednisone 60mg/m2 （max 100mg）,PO,D1-D5 every 21 days for total 6 courses) followed by Rituximab (375mg/m2 d1, every 21 days for total 2 courses)
• Препарат Four Courses of R-CHOP Plus Four Courses of Rituximab
  The patients will be given RCHOP (Rituximab 375mg/m2 ivgtt, D0, Cyclophosphamide 750mg/m2, ivgtt D1, doxorubicin 50mg/m2,ivgtt D1, Vincristine 1.4mg/m2（max 2mg）, ivgtt D1 Prednisone 60mg/m2 （max 100mg）,PO,D1-D5 every 21 days for total 4 courses) followed by Rituximab (375mg/m2 d1, every 21 days for total 4 courses)

Первичные конечные точки

• Progression of disease within 24 months [Срок оценки: Baseline up to data cut-off (up to approximately 24 months)]

Вторичные конечные точки (4)

• Overall response rate [Срок оценки: t the end of Cycle 8 (each cycle is 21 days)]
• Overall survival [Срок оценки: Baseline up to data cut-off (up to approximately 2 years)]
• Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0 [Срок оценки: Up to 30 days after completion of study treatment]
• Quality of life of patients [Срок оценки: Up to 30 days after completion of study treatment]

Критерии участия

Критерии включения

• Pathologically confirmed CD20 positive DLBCL based on 2016 WHO classification who achieved CR after 4 cycles of RCHOP therapy (examined by PET-CT, Deauville score 1-2)
• Treatment naïve
• IPI=0,1
• Age ≥ 14 or ≤75 years
• non-mass (The length of the lesion<7.5cm)
• ECOG=0,1
• Life expectancy>6 months
• Informed consented

Критерии исключения

• Have received systemic or local treatment including chemotherapy in the past
• Have received autologous stem cell transplantation in the past
• Past medical history of other malignant tumors, except basal cell carcinoma of the skin and cervical cancer in situ
• Accompanied by uncontrolled cardiovascular and cerebrovascular diseases, coagulopathy, connective tissue diseases, severe infectious diseases and other diseases
• Primary skin, primary central nervous system lymphoma
• Left ventricular ejection fraction ≦50%
• Other concurrent and uncontrolled situation which will affect the patient's medical status based on researchers decision
• Laboratory test value during screening: (unless it is caused by lymphoma) Neutrophils <1.5\*109/L Platelet<80\*109/L Hemoglobin <100g/L ALT or AST is 2 times higher than the upper limit of normal, AKP and bilirubin are 1.5 times higher than the upper limit of normal E. Creatinine level is higher than 1.5 times the upper limit of normal
• Psychiatric patients or other patients who are known or suspected to be unable to fully accomplish with the research protocol
• Pregnant or lactating women
• Patients with positive HbsAg test results need to undergo HBV-DNA test and can be admitted to the group after turning negative. In addition, if the HBsAg test result is negative, but the HBcAb test is positive (regardless of the HBsAb status), HBV-DNA is also required；if the result is positive, patients also need to be treated to become negative before entering the group
• Patients living with HIV
• Patients with TP53 mutations or those who have not undergone DLBCL hot spot gene screening

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 · 1 центр

• Ruijin Hospital — Шанхай

Идентификаторы

NCT: NCT05018520 · HLK-C-2015

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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