Chemotherapy, Total-Body Irradiation, Rituximab, and Donor Stem Cell Transplant in Treating Patients With B-Cell Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
A Non-Myeloablative Conditioning Regimen With Peri-Transplant Rituximab and the Transplantation of Hematopoietic Stem Cells From HLA-Compatible Related or Unrelated Donors in Patients With B Cell Lymphoid Malignancies
RATIONALE: Giving low doses of chemotherapy and total-body irradiation before a donor stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. Also, monoclonal antibodies, such as rituximab, can find cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving rituximab before transplant and cyclosporine and mycophenolate mofetil after transplant may stop this from happening.
PURPOSE: This phase II trial is studying the side effects and how well giving chemotherapy and radiation therapy together with rituximab and donor stem cell transplant works in treating patients with B-cell non-Hodgkin's lymphoma or chronic lymphocytic leukemia.
研究概览
地位
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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New York
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New York、New York、美国、10065
- Memorial Sloan Kettering Cancer Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following:
CD20-positive aggressive B-cell non-Hodgkin's lymphoma (NHL), including any of the following subtypes:
Diffuse large cell lymphoma*, meeting 1 of the following criteria:
- Relapsed disease after initial therapy, but failed to mobilize or had bone marrow involvement and therefore is not suitable for an autologous stem cell transplantation
- High-intermediate- or high-risk second-line, age-adjusted International Prognostic Index score and in second complete remission (CR) or partial remission (PR) after autologous stem cell transplantation
- Failed prior autologous stem cell transplantation and in PR or better after salvage chemotherapy
Large cell transformation of indolent NHL or chronic lymphocytic leukemia (CLL), meeting the following criteria:
- In CR or PR of the large cell component of disease after salvage chemotherapy or autologous stem cell transplantation
Mantle cell lymphoma*, meeting 1 of the following criteria:
- High-risk disease (e.g., p53 positivity) and in first CR or PR after initial therapy
- Relapsed disease after initial therapy and in second or third CR or PR after salvage chemotherapy NOTE: *No progressive disease at allograft work-up
CD20-positive indolent NHL (e.g., follicular lymphoma, small cell lymphoma, or marginal zone NHL) OR CLL
- Second or subsequent progression (pre-allograft cytoreduction necessary, but CR or PR not required)
- Relapsed disease must be biopsy-proven
Must have received pre-allograft salvage chemotherapy, including 1 of the following:
- Single autologous stem cell transplantation using high-dose chemotherapy conditioning within the past 120 days
- At least 2 courses of intensive combination chemotherapy (e.g., RICE [rituximab, ifosfamide, carboplatin, etoposide]), according to diagnosis, within the past 80 days
- CLL patients who have received CAMPATH do not have to receive pre-allograft salvage chemotherapy
HLA-compatible related or unrelated donor available
HLA-matched ≥ 9/10 of the A, B, C, DRB1, and DQB1 loci, as tested by high resolution typing
- One allele mismatch allowed
PATIENT CHARACTERISTICS:
- Karnofsky performance status 70-100%
- Creatinine < 1.2 mg/mL OR creatinine clearance ≥ 50 mL/min
- Bilirubin < 2.5 mg/dL
- AST and ALT ≤ 3 times upper limit of normal (unless benign congenital hyperbilirubinemia is present)
- Spirometry and corrected DLCO ≥ 50% of normal
- LVEF ≥ 40%
- Albumin ≥ 2.5 g/dL
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No active uncontrolled infection, including active infection with Aspergillus or other mold
- No HIV infection
- No hepatitis B antibody or antigen positivity
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior allogeneic transplantation
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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其他:treatment
This is a phase 2 study of a treatment regimen consisting of a non-myeloablative (NMA) conditioning regimen incorporating low dose chemotherapy and low dose radiation as well as peri-transplant Rituximab and the transplantation of peripheral blood stem cells (PBSC) or bone marrow if PBSC collection not possible from an HLA compatible related or unrelated donor in patients with B cell lymphoid malignancies including diffuse large cell (DLC) and mantle cell non-Hodgkin's lymphoma (NHL), indolent B cell NHL, or chronic lymphocytic leukemia (CLL).
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Overall Survival at 1 Year
大体时间:1 year
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1 year
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Time to Neutrophil Engraftment
大体时间:2 years
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2 years
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Time to Platelet Engraftment
大体时间:1 year
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1 year
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Incidence of Moderate to Severe Grades II to IV Graft Versus Host Disease (GVHD) at 100 Days
大体时间:100 days
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100 days
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Incidence of Chronic GVHD at 1 Year
大体时间:1 year
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1 year
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Immune Reconstruction/CD4+ Count at 3 Months
大体时间:3 months
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3 months
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Response to Treatment
大体时间:2 years
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2 years
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Immune Reconstruction/CD4+ Count at 6 Months
大体时间:6 months
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6 months
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Immune Reconstruction/CD4+ Count at 1 Year
大体时间:1 year
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1 year
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合作者和调查者
调查人员
- 首席研究员:Juliet Barker, MBBS、Memorial Sloan Kettering Cancer Center
- 首席研究员:Craig Moskowitz, MD、Memorial Sloan Kettering Cancer Center
- 首席研究员:Hugo R. Castro-Malaspina, MD、Memorial Sloan Kettering Cancer Center
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
- B细胞慢性淋巴细胞白血病
- III期成人弥漫性大细胞淋巴瘤
- III期成人免疫母细胞大细胞淋巴瘤
- IV期成人弥漫性大细胞淋巴瘤
- IV期成人免疫母细胞大细胞淋巴瘤
- 复发性成人弥漫性大细胞淋巴瘤
- 复发性成人免疫母细胞大细胞淋巴瘤
- III 期 1 级滤泡性淋巴瘤
- III期2级滤泡性淋巴瘤
- IV 期 1 级滤泡性淋巴瘤
- IV 期 2 级滤泡性淋巴瘤
- III期套细胞淋巴瘤
- IV期套细胞淋巴瘤
- 复发性 1 级滤泡性淋巴瘤
- 复发性 2 级滤泡性淋巴瘤
- 非连续性 II 期 1 级滤泡性淋巴瘤
- 非连续性 II 期 2 级滤泡性淋巴瘤
- 非连续性 II 期小淋巴细胞淋巴瘤
- 非连续性 II 期边缘区淋巴瘤
- 复发性边缘区淋巴瘤
- 复发性小淋巴细胞淋巴瘤
- III期小淋巴细胞淋巴瘤
- III期边缘区淋巴瘤
- IV期小淋巴细胞淋巴瘤
- IV期边缘区淋巴瘤
- 黏膜相关淋巴组织结外边缘区B细胞淋巴瘤
- 淋巴结边缘区B细胞淋巴瘤
- 脾边缘区淋巴瘤
- 复发性套细胞淋巴瘤
- 难治性慢性淋巴细胞白血病
- III期慢性淋巴细胞白血病
- IV期慢性淋巴细胞白血病
- 非连续性 II 期套细胞淋巴瘤
- 非连续性 II 期成人弥漫性大细胞淋巴瘤
- 非连续性 II 期成人免疫母细胞大细胞淋巴瘤
其他相关的 MeSH 术语
其他研究编号
- 06-150
- MSKCC-06150
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