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临床试验/NCT05245656
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2022年10月18日

概览

阶段
2 期
干预措施
RB/RBAC alternating
疾病 / 适应症
Mantle Cell Lymphoma
发起方
Kim, Seok Jin
入组人数
90
试验地点
1
主要终点
Progression-freesurvival
状态
招募中
最后更新
去年

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).

注册库
clinicaltrials.gov
开始日期
2022年10月18日
结束日期
2029年12月31日
最后更新
去年
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

发起方
Kim, Seok Jin
责任方
Sponsor Investigator
主要研究者

Kim, Seok Jin

Principal Investigator

Samsung Medical Center

入排标准

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

研究组 & 干预措施

RB/RBAC alternating

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

RB

Every 4 weeks for 6 cycles - Rituximab + Bendamustine

干预措施: RB

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)

研究点 (1)

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