KCT0004010招募中未知
A Phase II trial to evaluate the efficacy of Bortezomib, Cytarabine, and Dexamethasone in patients with relapsed or refractory mantle cell lymphoma
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 32
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •A. Over 19 years old
- •B. Based on tissue findings obtained through biopsy, an mantle cell lymphoma was diagnosed by a pathologist.
- •C. Relapsed after obtaining complete response after receiving chemotherapy for mantle cell lymphoma, or experienced disease progression during follow-up monitoring without showing complete response in previous chemotherapy.
- •D. ECOG performance status 2 or less
- •E. Adequate organ system function, defined as follows within two weeks of study registration;
- •i. White blood cells = 3,000 /ul
- •ii. Absolute neutrophil count = 1,000 /ul
- •iii. Platelets = 50,000 /ul
- •iv. Hemoglobin = 9.0 g/dL
- •v. Total bilirubin < 2 times upper limit of normal
- •vi. AST, ALT < 2.5 times upper limit of normal
- •vii. Serum creatinine < 1.5 times upper limit of normal
- •F. Understand and comply with contents of the research document and provide written informed consent voluntarily.
- •G. Willingness and ability to comply with visit schedules, treatment plans, laboratory tests and other study procedures.
排除标准
- •A. Previously treated with 4 or more lines of chemotherapy for mantle cell lymphoma
- •B. Previously treated with bortezomib-containing regimen for mantle cell lymphoma
- •C. Treated with a cytarabine-containing regimen as the last line and within 6 months
- •before registration
- •D. Prohibited from investigator products
- •E. Other cancer diagnosed within 5 years before registration except mantle cell lymphoma
- •F. Uncontrolled symptomatic Central Nervous System(CNS) involvement of mantle cell lymphoma
- •G. Uncontrolled systemic infection
- •H. Inherited immunodeficiency disease or acquired immune deficiency syndrome
- •I. Pregnancy
- •J. Breast-feeding woman
- •K. Peripheral neuropathy of grade 3 or higher
- •L. Other health conditions considered to be inappropriate for this trial in the primary
- •physician's opinion
研究者
相似试验
招募中
不适用
A phase II trial of the efficacy and safety of boring biopsy with rapid on-site evaluation for histological diagnosis of gastric mesenchymal tumorGastric mesenchymal tumorJPRN-UMIN000045414Osaka International Cancer Institute22
进行中（未招募）
不适用
A pilot phase II study to assess the efficacy of Brentuximab Vedotin administered sequentally with ABVD chemotherapy in patients with untreated Hodgkin LymphomaEUCTR2012-002012-46-ITAZIENDA OSPEDALIERA POLICLINICO DI MODENA
招募中
不适用
Phase1/2study evaluating safety and efficacy of bortezomib-lenalidomid-dexamethasone induction therapy followed by lenalidomide-dexamethasone consolidation and lenalidomide maintenance for newly diagnosed patients with multiple myeloma eligible for stem cell transplantation.Multiple myelomaJPRN-UMIN000016874Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital30
尚未招募
不适用
Probiotics for patients with cancersCTRI/2021/03/032021Christian Medical College Vellore
进行中（未招募）
不适用
A phase II pilot trial to evaluate the efficacy of treatment with Pegilate G-CSF in a group of elderly patients AML without chemotherapy indications - NDEUCTR2006-006541-14-ITAZIENDA OSPEDALIERA SPEDALI CIVILI DI BRESCIA