Chemotherapy, Radiation Therapy, and Umbilical Cord Blood Transplantation in Treating Patients With Hematologic Cancer
Cord Blood Transplantation for Hematologic Malignancies and Bone Marrow Failure Syndromes
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Umbilical cord blood transplantation may allow doctors to give higher doses of chemotherapy or radiation therapy and kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of chemotherapy, radiation therapy, and umbilical cord blood transplantation in treating patients with hematologic cancer.
研究概览
地位
详细说明
OBJECTIVES: I. Determine the safety, efficacy, and toxicity of using cord blood as a source for stem cell transplantation in patients with hematologic malignancies.
OUTLINE: Patients undergo autologous bone marrow harvesting or peripheral stem cell collection prior to transplant regimen, unless the patient has acute leukemia in relapse, aplastic anemia, or myelodysplastic syndrome. Arm I: Patients eligible to undergo total body irradiation (TBI) first receive cyclophosphamide IV over 2 hours on days -5 and -4, then undergo TBI twice a day on days -3 to -1. Patients also receive antithymocyte globulin (ATG) IV over 10 hours on days -3 to -1. Cord blood is infused on day 0. Arm II: Patients not eligible to receive TBI receive oral busulfan every 6 hours on days -7 to -4 for a total of 16 doses. Cyclophosphamide, ATG, and cord blood are then administered as in arm I. All patients receive cyclosporine on days -2 to 180, methylprednisolone on days 5-180, and filgrastim (G-CSF) from day 1. Patients are followed weekly until day 180 and then monthly for 2 years.
PROJECTED ACCRUAL: A total of 20 patients (10 patients per arm) will be accrued for this study within 4 years.
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
-
-
New York
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Buffalo、New York、美国、14263-0001
- Roswell Park Cancer Institute
-
-
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: Histologically proven hematologic malignancy Acute lymphocytic leukemia (ALL): In second or later remission In first remission with poor prognostic features (Philadelphia chromosome positive) Acute myeloid leukemia (AML): In second or later remission In first remission with poor prognostic features, e.g., Arising from myelodysplastic syndrome Cytogenetics with -5, -7, +8, 11q23 abnormalities Complex cytogenetics AML or ALL refractory to induction or in relapse Myelodysplastic syndrome Chronic myelogenous leukemia Severe aplastic anemia or Fanconi's anemia Relapsed Hodgkin's disease Relapsed non-Hodgkin's lymphoma Multiple myeloma No suitable family donor matched for 5 or 6 HLA antigens (A, B, DR) No suitable unrelated donor matched for 6 HLA antigens Cord blood donor available matched for 4-6 out of 6 HLA antigens
PATIENT CHARACTERISTICS: Age: 5 to 50 Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin less than 3 times normal Alkaline phosphatase less than 3 times normal SGOT less than 3 times normal Renal: Creatinine less than 2 times normal OR Creatinine clearance greater than 60 mL/min Cardiovascular: MUGA with ejection fraction at least 50% Pulmonary: DLCO and spirometry at least 60% OR Exercise VO2 max/kg at least 15 mL/min/kg Other: HIV antibody negative Hepatitis B surface antigen negative No active bacterial, viral, or fungal infection
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Prior radiotherapy allowed If following limits have not been exceeded, patient may receive total body irradiation: No prior radiation to one entire kidney Whole liver received no greater than 1000 cGy No prior whole abdomen radiotherapy Small bowel received no greater than 3000 cGy Heart received no greater than 1800 cGy No prior whole lung radiotherapy CNS received less than 30 cGy (whole brain or any portion of the spine) Surgery: Not specified
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 |
|---|---|
|
实验性的：Arm 1
Patients eligible to undergo total body irradiation (TBI) first receive cyclophosphamide IV over 2 hours on days -5 and -4, then undergo TBI twice a day on days -3 to -1.
Patients also receive antithymocyte globulin (ATG) IV over 10 hours on days -3 to -1.
Cord blood is infused on day 0
|
四、
四、
四、
IV
IV
IV
IV
IV
High energy X-rays
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Overall Response Rate
大体时间：day +100 after Cord Blood Transplant
|
Continuous complete remission (for patients in complete remission before treatment) or induced complete remission (for patients not in complete remission before treatment)
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day +100 after Cord Blood Transplant
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Progression-free Survival
大体时间：1 year
|
time to disease progression or death due to any cause
|
1 year
|
合作者和调查者
调查人员
- 学习椅：Barbara Jean Bambach, MD、Roswell Park Cancer Institute
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
- 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
- 复发性成人伯基特淋巴瘤
- 复发性儿童小无裂细胞淋巴瘤
- 复发性儿童大细胞淋巴瘤
- 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
- 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
- 慢性期慢性粒细胞白血病
- 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
- 儿童免疫母细胞大细胞淋巴瘤
- 复发/难治性儿童霍奇金淋巴瘤
- 复发性成人弥漫性小裂细胞淋巴瘤
- 复发性成人弥漫性混合细胞淋巴瘤
- 母细胞期慢性粒细胞白血病
- 复发性慢性粒细胞白血病
- 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
- 复发性边缘区淋巴瘤
- 复发性小淋巴细胞淋巴瘤
- 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
- I期多发性骨髓瘤
- 复发性成人淋巴母细胞淋巴瘤
- 复发性套细胞淋巴瘤
- 难治性多发性骨髓瘤
- 复发性成人急性淋巴细胞白血病
- 复发性儿童急性淋巴细胞白血病
- 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
- 复发性儿童淋巴母细胞淋巴瘤
- 脑膜慢性粒细胞白血病
- 儿童弥漫性大细胞淋巴瘤
- 伯基特淋巴瘤
- 移植物抗宿主病
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
- 肿瘤
- 淋巴增生性疾病
- 淋巴系统疾病
- 免疫增生性疾病
- 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
- 癌前病变
- 淋巴瘤
- 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
- 移植物抗宿主病
- 药物的生理作用
- 药理作用的分子机制
- 抗感染药
- 自主代理
- 周围神经系统药物
- 酶抑制剂
- 抗炎药
- 抗风湿药
- 抗肿瘤药
- 免疫抑制剂
- 免疫因素
- 止吐药
- 胃肠道药物
- 糖皮质激素
- 荷尔蒙
- 激素、激素替代品和激素拮抗剂
- 神经保护剂
- 保护剂
- 抗肿瘤药，烷基化
- 烷化剂
- 清髓性激动剂
- 皮肤病药物
- 抗真菌剂
- 神经钙蛋白抑制剂
- 甲泼尼龙
- 环磷酰胺
- 白消安
- 抗淋巴细胞血清
- 环孢菌素
- 环孢菌素
其他研究编号
- DS 97-26
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环磷酰胺的临床试验
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Tianjin Medical University Cancer Institute and...CSPC Ouyi Pharmaceutical Co., Ltd.尚未招聘