Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer, Metastatic Kidney Cancer, or Aplastic Anemia
Non-myeloablative Allogeneic Stem Cell Transplantation With Match Unrelated Donors for Treatment of Hematologic Malignancies and Renal Cell Carcinoma and Aplastic Anemia
RATIONALE: Giving low doses of chemotherapy before a donor stem cell transplant using stem cells that closely match the patient's stem cells, helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving antithymocyte globulin before transplant and cyclosporine and mycophenolate mofetil after transplant may stop this from happening.
PURPOSE: This clinical trial is studying how well a donor stem cell transplant works in treating patients with hematologic cancer, metastatic kidney cancer, or aplastic anemia.
研究概览
地位
详细说明
OBJECTIVES:
Primary
- Determine the treatment-related mortality (TRM) rate at 100 days in patients with hematologic malignancy, metastatic renal cell carcinoma, or aplastic anemia undergoing nonmyeloablative allogeneic stem cell transplantation using matched unrelated donors.
Secondary
- Determine the TRM at 12 months in patients treated with this regimen.
- Determine the 6-month engraftment rate in patients treated with this regimen.
- Determine 1-year overall survival of patients treated with this regimen.
OUTLINE:
- Nonmyeloablative preparative regimen: Patients receive fludarabine IV over 30 minutes on days -7 to -3, busulfan* IV over 6 hours on days -4 and -3, and anti-thymocyte globulin IV over 6-10 hours on days -4 to -1.
NOTE: *Patients with aplastic anemia receive cyclophosphamide IV over 2 hours on days -6 to -3 instead of busulfan.
- Allogeneic stem cell reinfusion: Patients undergo allogeneic bone marrow or peripheral blood stem cell transplantation on day 0. Patients then receive filgrastim (G-CSF) subcutaneously daily beginning on day 7 and continuing until blood counts recover.
- Graft-vs-host disease (GVHD) prophylaxis: Patients receive tacrolimus orally twice daily or IV continuously beginning on day -2 and continuing for approximately for 6-12 months after transplantation. Patients also receive mycophenolate mofetil orally or IV twice daily on days 0 to 60 and methotrexate IV on days 1, 3, 6, and 11**.
NOTE: **Patients with aplastic anemia receive methotrexate IV on days 1, 3, and 6 (not day 11).
- Donor lymphocyte infusion (DLI): After day 180, patients with no evidence of active GVHD may receive DLI. A second DLI may be infused > 8 weeks after the first in the absence of disease response or GVHD.
After completion of study treatment, patients are followed periodically for at least 2 years.
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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California
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San Francisco、California、美国、94115
- UCSF Comprehensive Cancer Center
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North Carolina
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Winston-Salem、North Carolina、美国、27157-1096
- Wake Forest University Comprehensive 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:
- Aplastic anemia not responsive to immunosuppressive therapy
- Metastatic renal cell carcinoma
Hematologic malignancy, including any of the following:
Acute myeloid leukemia (AML)* not curable with chemotherapy and meeting any of the following criteria:
- AML with high-risk cytogenetic abnormalities (e.g., -7, -7q, -5, -5q, complex, Philadelphia chromosome-positive [Ph+])
- AML evolved from prior myelodysplasia
- AML secondary to prior chemotherapy
- Failed to achieve remission
- In second or subsequent remission NOTE: *Marrow blasts < 10%- can be achieved by chemotherapy
Myelodysplasia* with any of the following high-risk features:
- Adverse cytogenetics (-7, 7q, -5, -5q, complex)
- Excess blasts
- Prior conversion to AML
- Severe cytopenias with absolute neutrophil count < 500/mm^3 or platelet count < 20,000/mm^3 NOTE: *Marrow blasts < 10%- can be achieved by chemotherapy
Acute lymphoblastic leukemia (ALL)* not curable with chemotherapy and meeting any of the following criteria:
- High-risk cytogenetics (Ph+, 11q23 abnormalities, monosomy 7)
- More than 1 induction course required to achieve remission
- Failed to enter remission
- In second or subsequent remission NOTE: *Marrow blasts < 10 %
Chronic lymphocytic leukemia (CLL) with high-risk features, including any of the following:
- Refractory to initial or subsequent therapy
- Progression after initial response to therapy
- Prolymphocytic morphology
Follicular lymphoma with any of the following high-risk features:
- Refractory to initial or subsequent therapy
- Progression after response to initial therapy
- Has ≥ 3 International Prognostic Index (IPI) risk factors
Multiple myeloma
- Stage II-III disease confirmed at diagnosis or after initial progression
Other lymphoma that has failed to respond to primary therapy, progressed, or recurred after prior therapy, including any of the following:
- Diffuse large cell lymphoma
- Mantle cell lymphoma
- Hodgkin's lymphoma
Myeloproliferative disease with evidence of disease acceleration, including any of the following:
- Myelofibrosis
- Polycythemia vera
- Essential thrombocythemia
- Chronic myeloid leukemia (CML) that failed to be controlled by imatinib mesylate
- Disease must be stable or responding to therapy
No rapid progression of malignant disease
- Expected time to disease progression > 12 weeks
- Not eligible for autologous stem cell transplantation
Matched unrelated donor available
- 9/10 HLA matched, including HLA-A, -B, -C, -DR, and -DQ
PATIENT CHARACTERISTICS:
- Creatinine < 2.0 mg/dL
- Creatinine clearance > 40 mL/min
Bilirubin < 3 mg/dL
- Elevated total bilirubin due to Gilbert's disease allowed if direct bilirubin is normal
- AST < 4 times upper limit of normal
- Hepatitis C or B allowed provided bilirubin and AST are normal
- Cardiac ejection fraction > 30%
- DLCO > 40% of predicted
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No uncontrolled active infection requiring ongoing antibiotic treatment
- No poor performance status
- No poor organ function
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Prior stem cell or bone marrow transplantation allowed
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 屏蔽:无(打开标签)
合作者和调查者
调查人员
- 首席研究员:Charles A. Linker, MD、University of California, San Francisco
研究记录日期
研究主要日期
学习开始
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 (估计)
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
- IV期肾细胞癌
- 复发性肾细胞癌
- 原发性骨髓纤维化
- IV期3级滤泡性淋巴瘤
- 复发性 3 级滤泡性淋巴瘤
- 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
- 复发性儿童大细胞淋巴瘤
- 慢性粒单核细胞白血病
- 新生骨髓增生异常综合征
- 既往治疗过的骨髓增生异常综合征
- 继发性骨髓增生异常综合征
- 具有 11q23 (MLL) 异常的成人急性髓性白血病
- 伴有 inv(16)(p13;q22) 的成人急性髓性白血病
- 成人急性髓性白血病伴 t(15;17)(q22;q12)
- 成人急性髓性白血病伴 t(16;16)(p13;q22)
- 继发性急性髓性白血病
- 儿童急性淋巴细胞白血病处于缓解期
- 儿童急性髓性白血病处于缓解期
- 幼年粒单核细胞白血病
- 慢性期慢性粒细胞白血病
- 儿童慢性粒细胞白血病
- 儿童骨髓增生异常综合征
- 复发性成人急性髓性白血病
- 缓解期成人急性髓性白血病
- 复发性成人霍奇金淋巴瘤
- 复发/难治性儿童霍奇金淋巴瘤
- 母细胞期慢性粒细胞白血病
- 复发性慢性粒细胞白血病
- III 期 1 级滤泡性淋巴瘤
- III期2级滤泡性淋巴瘤
- III期3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
- II期多发性骨髓瘤
- III期多发性骨髓瘤
- 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
- 复发性成人淋巴母细胞淋巴瘤
- 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
- 难治性多发性骨髓瘤
- 复发性成人急性淋巴细胞白血病
- 真性红细胞增多症
- 原发性血小板增多症
- 幼淋巴细胞白血病
- 复发性儿童急性淋巴细胞白血病
- 非连续性 II 期 3 级滤泡性淋巴瘤
- 加速期慢性粒细胞白血病
- 缓解期成人急性淋巴细胞白血病
- 复发性儿童急性髓性白血病
- 骨髓增生异常/骨髓增生性肿瘤,无法分类
- 慢性嗜酸性白血病
- 慢性中性粒细胞白血病
- 非典型慢性粒细胞白血病,BCR-ABL1 阴性
其他相关的 MeSH 术语
- 病理过程
- 心血管疾病
- 血管疾病
- 免疫系统疾病
- 组织学类型的肿瘤
- 淋巴增生性疾病
- 淋巴系统疾病
- 免疫增生性疾病
- 泌尿系肿瘤
- 泌尿生殖系统肿瘤
- 按部位分类的肿瘤
- 肾脏疾病
- 泌尿系统疾病
- 腺癌
- 癌
- 肿瘤、腺体和上皮
- 疾病
- 骨髓疾病
- 血液病
- 出血性疾病
- 止血障碍
- 副蛋白血症
- 血液蛋白失调
- 贫血
- 癌前病变
- 骨髓衰竭疾病
- 肿瘤
- 淋巴瘤
- 肾脏肿瘤
- 癌,肾细胞
- 综合症
- 骨髓增生异常综合征
- 多发性骨髓瘤
- 肿瘤,浆细胞
- 白血病
- 白血病前期
- 浆细胞瘤
- 骨髓增生性疾病
- 骨髓增生异常-骨髓增生性疾病
- 贫血,再生障碍性
- 药物的生理作用
- 药理作用的分子机制
- 抗感染药
- 核酸合成抑制剂
- 酶抑制剂
- 抗风湿药
- 抗代谢药、抗肿瘤药
- 抗代谢物
- 抗肿瘤药
- 免疫抑制剂
- 免疫因素
- 抗肿瘤药,烷基化
- 烷化剂
- 清髓性激动剂
- 皮肤病药物
- 抗菌剂
- 抗生素、抗肿瘤药
- 生殖控制剂
- 抗结核药
- 堕胎药,非甾体
- 堕胎剂
- 叶酸拮抗剂
- 抗生素,抗结核药
- 神经钙蛋白抑制剂
- 环磷酰胺
- 氟达拉滨
- 磷酸氟达拉滨
- 甲氨蝶呤
- 他克莫司
- 麦考酚酸
- 白消安
- 抗淋巴细胞血清
其他研究编号
- CDR0000463522
- UCSF-01251
- UCSF-H5010-19585-05
- UCSF-2101
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