NCT03383406Enrolling By Invitation2 期
A Phase II Trial of Ifosfamide, Etoposide, Cytarabine, and Methotrexate (IVAM) Chemotherapy for Refractory or Relapsed Diffuse Large B Cell Lymphoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 入组人数
- 30
- 主要终点
- Response
研究概览
简要总结
A phase II trial of ifosfamide, etoposide, cytarabine, and methotrexate (IVAM) chemotherapy for refractory or relapsed diffuse large B cell lymphoma
详细描述
Diffuse Large B-Cell lymphoma is currently used as a standard treatment, with a combination of chemotherapy (R-CHOP), which includes Rituximab. However, the survival rate is very poor if the primary treatment is refractory or relapsed within a year or less. The duration of these patients ' lives is around one year and the five-year survival rate is 15-20 %. Thus, a new treatment strategy is needed to improve the survival of the patient with DLBCL, which are either refractory and relapsed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Histologically confirmed adult patients diagnosed with DLBCL refractory or relapsed.
- •Large scale B cell lymphoma not received ASCT(autologous stem-cell transplantation ) after primary chemotherapy
- •At least one measurable lesion
- •≥1 cm in greatest transverse diameter by spiral CT
- •≥2 cm in greatest transverse diameter by conventional CT
- •≥1 cm in visible skin lesion
- •≥2 cm in digital exploration
- •Performance status: Eastern Cooperative Oncology Group (ECOG) 0-
- •Age 19~59yrs
- •MUGA(multiple gated acquisition scan ): Non-Clinical significant and 2D-Echo( Cardiac Index ≥ 50 % )
- •Adequate renal function: serum creatinine level < 2.0 mg/dL(177μmol/L) Adequate liver functions: Transaminase (AST/ALT) < 3 X upper limit of normal value (or < 5 x ULN in the presence of DLBCL involvement of the liver), bilirubin < 2 X upper normal value (or < 5 x upper limit of normal in the presence of DLBCL involvement of the liver)
- •Adequate hematological function: hemoglobin ≥ 9.0 g/dL absolute neutrophil count (ANC) ≥ 1,500/μL and platelet count ≥ 75,000/μL,
- •A negative serum or urine pregnancy test prior to treatment must be available both for pre menopausal women and for women who are < 1 years after the onset of menopause.
排除标准
- •Pre-treatment for ASCT
- •Central nervous system (CNS) involvement by lymphoma
- •Prior history of malignancies other than lymphoma (except for treated Non Melanoma Skin Cancer, early gastric cancer or carcinoma in situ of the cervix or breast or untreated prostatic cancer without any plan for a treatment) unless the patient has been free of the disease for ≥ 5 years
- •Pregnant or lactating woman, Childbearing potential not employing adequate contraception
- •Active uncontrolled infections(Bacterial, Viral, Fungus)
- •Other serious illness or medical conditions
- •Other experimental drug under investigation, or concomitant chemotherapy, hormonal therapy, or immunotherapy.
研究组 & 干预措施
I Ifosfamide, Etoposide, Cytarabine, and Methotrexate (IVAM)
Experimental
干预措施: Ifosfamide, Etoposide, Cytarabine, and Methotrexate (IVAM) Chemotherapy (Drug)
结局指标
主要结局
Response
时间窗: 2 to 3 weeks after completion of the 2nd cycle of treatment (each cycle is 28 days)
CT, PET-CT(positron emission computed tomography )
次要结局
- Assess response rate(Afer 2years completion of the treatment up to 3years)
研究者
Cheolwon Suh
Professor
Asan Medical Center
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