NCT05245656招募中2 期
A Randomized Phase II Trial Comparing Rituximab/Bendamustine(RB) Alternating With Rituximab/Bendamustine/Cytarabine(RBAC) With RB as Induction Therapy in Elderly Patients With Newly Diagnosed and Transplant-ineligible Mantle Cell Lymphoma
Kim, Seok Jin1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2022年10月18日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Progression-freesurvival
研究概览
简要总结
This is a phase 2, multicenter, open-label, active-controlled randomized trial to determine efficacy and safety of rituximab/bendamustine (RB) alternating with rituximab/bendamustine/cytarabine (RBAC) compared with standard RB alone in the first-line treatment of elderly patients with mantle cell lymphoma, who are not eligible for high-dose therapy followed by autologous stem cell transplantation.
详细描述
Eligible patients will be randomly assigned to either the investigational treatment arm (RB alternating with RBAC) or the standard treatment arm (RB) in a 1:1 ratio. Patients will be stratified by age (≥70 years vs. 60-69), histologic morphology (blastoid/pleomorphic vs. non-blastoid/non-pleomorphic), and MIPI-C risk score (0/1 vs. 2/3).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •newly diagnosed, previously untreated, histologically confirmed CD20+ mantle cell lymphoma, confirmed by WHO classification criteria
- •age ≥70 years or 60-69 years if the patients are ineligible for high-dose therapy with autologous stem cell transplantation.
- •ECOG performance status 2 or less
- •Adequate organ functions
- •adequate heart function: LVEF ≥50% by echocardiography or MUGA
- •adequate renal function: serum creatinine ≤ 2.0mg/dL or CrCl ≥40 mL/min based on the Cockcroft-Gault method
- •adequate hepatic function: ≤2.5 times the upper limit of ALT (≤5 times the upper limit of ALT if the elevation is attributed by underlying lymphoma) and ≤2 times the upper limit of ALT (≤3 times the upper limit of total bilirubin if the elevation is attributed by underlying lymphoma)
- •adequate hematologic function: absolute neutrophil counts (ANC) ≥ 1,500/mL, platelet counts ≥ 100,000/mL (any ANC and platelet counts are allowed, if they were related to bone marrow involvement)
- •Written informed consent
排除标准
- •In-situ mantle cell lymphoma
- •Ann Arbor stage 1 disease
- •Prior treatment for Hodgkin lymphoma or non-Hodgkin lymphoma within the last 5 years.
- •Active malignancy within the past 3 years except for localized non-melanoma skin cancer, papillary thyroid cancer, cervical carcinoma in situ, breast cancer in situ, or localized prostate cancer that has been definitely treated,
- •Central nervous system involvement
- •HBsAg (+) or anti-HBc Ab (+) (patients will be eligible if they receive appropriate prophylactic antiviral therapy using entecavir, tenofovir, and so on)
- •History of prior hepatitis C infection (patients positive for HCV IgG will be eligible if they are negative for HCV-RNA)
- •Known history of human immunodeficiency virus (HIV) infection
- •any serious illness or medical conditions that are unstable or could jeopardize the safety of the patient and his/her compliance in the study
- •Congestive heart failure ≥ NYHA class 3
- •Acute coronary syndrome within 6 months (unstable angina or new-onset angina, myocardial infarct, or ventricular arrhythmia)
- •History of significant neurological or psychological disorder including dementia and seizure disorder
- •Severe chronic obstructive pulmonary disease with hypoxemia
- •Cerebrovascular disease including transient ischemic attack within the past 6 months
- •Non-healing wound, ulcer, or bone fracture
- •Active uncontrolled bacterial, viral, or fungal infection requiring systemic therapy
- •concomitant administration of any other experimental drugs under investigation
- •Known hypersensitivity to bendamustine, rituximab, cytarabine, or mannitol
- •major surgical procedure or significant trauma within 28 days before start of study treatment, open biopsy within 7 days before start of study treatment
- •If the patient's partner is a woman who could possibly get pregnant, men who didn't have a vasectomy must agree to use medically recommended methods for adequate contraception (tubal ligation, intrauterine devices, or barriers [diaphragm, cervical cap] in the patient's partner and the use of condoms in men) when sexually active.
研究组 & 干预措施
RB/RBAC alternating
Experimental
Every 4 weeks for 6 cycles
RB (1st, 3rd, and 5th cycles)
- Rituximab + Bendamustine
RBAC (2nd, 4th, and 6th cycles)
- Rituximab + Bendamustine + Cytarabine
干预措施: RB/RBAC alternating (Drug)
RB
Active Comparator
Every 4 weeks for 6 cycles
- Rituximab + Bendamustine
干预措施: RB (Drug)
结局指标
主要结局
Progression-freesurvival
时间窗: Up to 84 months
次要结局
- Event Free Survival(Up to 84 months)
- Adverse events(From the day 1 of the clinical trial to 28 days after last drug administration)
- Overall response rate(Up to 84 months)
- Overall Survival(Up to 84 months)
- Duration of Response(Up to 84 months)
研究者
Kim, Seok Jin
Principal Investigator
Samsung Medical Center
研究点 (1)
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