NCT01484093已完成1 期
Sequential Chemo-Radioimmunotherapy Followed by Autologous Transplantation for Patients With Untreated Advanced Stage Mantle Cell Lymphoma: A Phase I/II Trial
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 8
- 主要终点
- maximum tolerated dose (MTD)
研究概览
简要总结
Mantle cell lymphoma (MCL) is a rare and aggressive type of lymphoma, with only about 3,000 cases diagnosed per year. MCL is considered a difficult cancer to treat. This study is being done to better understand how to treat MCL.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previously untreated advanced stage mantle cell lymphoma (Clinical stage 2 with abdominal involvement, stage 3 and stage 4).
- •Histologic diagnosis confirmed by MSKCC pathologist as mantle cell lymphoma with Cyclin D1, or D2 and/or, D3 staining performed. Presence of measurable disease as determined by FDG-PET, CT, endoscopy, colonoscopy, or bone marrow biopsy.
- •Transplant eligibility as confirmed by the Disease Management Team.
- •KPS ≥ 70%.
- •Adequate organ function:
- •WBC ANC ≥ 1000 cells/mcL and platelet count ≥ 100,000 cells/mcL unless felt to be secondary to underlying mantle cell lymphoma at which any count is permissible.
- •Adequate renal function as determined by Cr < or = to 1.5 mg/dL or 24 hr creatinine clearance ≥ 50 ml/hr
- •Adequate hepatic function as determined by total bilirubin < or = to 1.5x ULN (unless known Gilbert syndrome) and AST < or = to 5.0x ULN.
- •Cardiac ejection fraction greater than or equal to 50% as determined by echocardiogram or MUGA.
- •For patients ≥ age 60, a stress echocardiogram will be required, with same requirements as above.
- •DLCO greater than or equal to 50% as determined by pulmonary function tests performed prior to initiation of treatment.
- •Patients with positive Hepatitis B serologies will be treated per institutional guidelines.
排除标准
- •Prior treatment for mantle cell lymphoma, including more than 7 days of steroids, immunotherapy, radioimmunotherapy, or chemotherapy. This does not include patients who have initiated R-CHOP at an outside institution within 2 weeks of enrollment.
- •Patients using > or = to 10mg/day of steroids for any chronic medical condition
- •Pregnant or breast-feeding. Note: Pre-menopausal patients must have a negative, serum HCG within 14 days of enrollment,.
- •HIV positive or Hepatitis C antibody positive.
结局指标
主要结局
maximum tolerated dose (MTD)
时间窗: 1 year
of HIDAC. For this study the MTD will be the dose at which no more than one grade 3 CNS toxic event (defined by CTCAE 4.0 as severe neurologic symptoms limiting self care ADLs') up to two weeks following HIDAC occurs among a 6 patient cohort. Phase I
3 year Event Free Survival (EFS)
时间窗: 3 years
from 67% (historical control) to 80 % in all patients. The EFS interval starts at enrollment date, and an event is defined as death from any cause or progression of disease. Patients who have completed the ASCT but elect to be removed from the study or lost to follow-up by the end of the third year will be counted as events as well. Phase II
次要结局
- 3-year Event Free Survival (EFS)(3 years)
- rates of complete remission (CR)(1 year)
- Determine 3 year overall survival (OS).(3 years)
研究者
研究点 (8)
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