Bone Marrow Transplantation in Treating Patients With Hematologic Cancer
Transplantation of HLA Haploidentical Marrow Cells After Ex Vivo Exposure to Recipient Alloantigen in Presence of CTLA4-Ig - A Phase II Study of Tolerance Induction in Donor T Cells by Blockade of the CD80/CD86:CD28 Costimulatory Signal
RATIONALE: Bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy and radiation therapy used to kill tumor cells.
PURPOSE: Phase II trial to study the effectiveness of bone marrow transplantation in treating patients who have hematologic cancer.
研究概览
地位
详细说明
OBJECTIVES: I. Determine the incidence and severity of acute graft versus host disease after transplantation of HLA haploidentical bone marrow preincubated with alloantigen and CTLA4-Ig ex vivo in patients with hematologic malignancies. II. Determine the engraftment rate with this treatment regimen in these patients. III. Determine the safety of this treatment regimen in these patients. IV. Determine the incidence of infection and relapse after this treatment regimen in these patients. V. Determine whether host specific tolerance develops in these patients after receiving this treatment regimen.
OUTLINE: This is a multicenter study. Patients undergo leukapheresis to collect white blood cells which are incubated with donor bone marrow cells in the presence of CTLA4-Ig for 36 hours. Patients undergo total body irradiation on days -7, -6, -5, and -4 and receive cyclophosphamide IV on days -3 and -2. Patients with acute lymphocytic leukemia, prior lymphoid blast crisis chronic myelogenous leukemia, high grade non-Hodgkin's leukemia (NHL), intermediate grade NHL with prior marrow or extramedullary disease, or prior CNS leukemia receive 2 doses of methotrexate intrathecally prior to bone marrow transplantation, and 4-6 doses following. Patients receive bone marrow transplantation on day 0; methotrexate IV on days 1, 3, 6, and 11; and cyclosporine IV on days -1 to 50. Patients are followed weekly for 1 month, monthly for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study over 1-2 years.
研究类型
阶段
- 阶段2
联系人和位置
学习地点
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Maryland
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Baltimore、Maryland、美国、21287
- Johns Hopkins Oncology Center
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Massachusetts
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Worcester、Massachusetts、美国、01655
- University of Massachusetts Memorial Medical Center
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South Carolina
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Columbia、South Carolina、美国、29203
- University of South Carolina School of Medicine
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Washington
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Seattle、Washington、美国、98109
- Fred Hutchinson Cancer Research 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: Any of the following hematologic malignancies: Acute myelogenous leukemia in second or greater remission or relapse High risk acute lymphoblastic leukemia First complete remission with high risk cytogenetics [e.g., t(9;22), t(8;14), or t(4;11)] or slow early response OR Any second or greater remission OR Relapse or induction failure Relapsed non-Hodgkin's lymphoma (NHL) with chemotherapy sensitive disease Multiple myeloma with chemotherapy sensitive disease Chronic lymphocytic leukemia with chemotherapy sensitive disease Myelodysplastic syndrome Chronic myelogenous leukemia (CML) in accelerated phase, blast phase, or remission after blast phase Juvenile CML Patients must have haploidentical donors and meet the following criteria: Lack an HLA A, B, and DR matched related donor Lack an HLA A, B, DRB1 matched or single allele mismatched unrelated donor or for whom the following apply: High likelihood of rapid disease progression while an unrelated donor search is in progress AND Review of the patient HLA typing, gene frequency, results of the preliminary search and the donor pool suggest that a donor will not be found within a suitable time frame Lack an HLA A, B, DRB1 matched cord blood unit or lack a cord blood unit that has an adequate cell dose and is mismatched for 1-2 HLA A, B, DRB1 Do not have an indication for autologous transplant, including patients with NHL or multiple myeloma who are not eligible for autologous transplant Negative antidonor antibody crossmatch
PATIENT CHARACTERISTICS: Age: Under 51 Performance status: Not specified Life expectancy: No patients with life expectancy severely limited by diseases other than malignancy Hematopoietic: See Disease Characteristics Hepatic: AST no greater than 2 times normal Renal: Creatinine no greater than 2 times normal OR Creatinine clearance at least 50% for age, weight, and height Cardiovascular: No cardiac insufficiency requiring treatment No symptomatic coronary artery disease Pulmonary: No severe hypoxemia pO2 less than 70 mm Hg with decreased DLCO less than 70% predicted OR No mild hypoxemia pO2 less than 80 mm Hg with severely decreased DLCO less than 60% predicted Other: HIV negative Not pregnant or nursing Fertile patients must use effective contraception during and for one year after study No leukoencephalopathy
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: No more than 3,000 cGy prior radiotherapy to brain No more than 1,500 cGy prior radiotherapy to chest or abdomen 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
合作者和调查者
调查人员
- 学习椅:Ann E. Woolfrey, MD、Fred Hutchinson Cancer Center
研究记录日期
研究主要日期
学习开始
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 (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
- 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
- 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
- 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
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
- 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
- 抗真菌剂
- 生殖控制剂
- 堕胎药,非甾体
- 堕胎剂
- 叶酸拮抗剂
- 神经钙蛋白抑制剂
- 环磷酰胺
- 甲氨蝶呤
- 环孢菌素
- 环孢菌素
其他研究编号
- 1457.00
- FHCRC-1457.00
- NCI-H00-0059
- CDR0000067879 (注册表标识符:PDQ)
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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