Safety and Efficacy of Campath in Nonmyeloablative Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Number of Participants Surviving 100 days post-transplant
研究概览
简要总结
Objective of the low-dose transplant regimen must produce the following effects:
- Suppression of the patient's immune system to prevent rejection of the donor cells;
- Control of the lymphoma. The pretransplant regimen must suppress the lymphoma sufficiently to prevent marked progression of the tumor and allow time for the GVT effect to occur.
详细描述
Alemtuzumab is a drug that can specifically attack some types of leukemia and lymphoma cells. In addition, it suppresses the patients' immune system, therefore helps preventing the rejection of donor marrow or stem cells.
Before treatment starts, patients will have a physical exam, including blood tests (between 100 - 120 cc) and urine tests. Women who are able to have children will have a pregnancy test. Bone marrow samples will be taken. Patients will have a chest x-ray, CT scans and EKG, and tests of lung function.
Blood tests (between 100 - 120 cc) marrow sampling, and x-rays will be done as needed to track the effects of the transplant. For bone marrow sampling, a large needle is placed into the numbed hipbone. The bone marrow is then withdrawn through the needle. Patients will have transfusions of blood and platelets as needed. Blood tests (between 100 - 120 cc) will be done daily while patients are in the hospital.
Alemtuzumab will be injected into the patient's vein. This will be done 3 days in a row (days 1 to 3). The drugs diphenhydramine (Benadryl) and acetaminophen (Tylenol) will be given in to prevent or ease side effects.
Patients will also receive fludarabine and cyclophosphamide daily for 3 days. They will be given on the same days as alemtuzumab. Rituximab will be given (to some patients only, based on the subtypes of lymphomas) eight days before the transplant and then weekly for a total of 4 doses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Up to 70 years of age (physiological).
- •Any histological subtype of lymphoid malignancies (those with CD20 negative disease will not receive Rituximab).
- •Patients in relapse with a partial remission or stable disease.
- •Patients who failed a prior autologous transplant are also eligible.
- •Patients must have a matched unrelated donor and no human leukocyte antigen (HLA) identical sibling is available. Point scale (PS)<
- •Patients are included even if they were previously exposed to Campath or Rituximab.
排除标准
- •Past history of anaphylaxis following exposure to rat- or mouse-derived COR-grafted humanized monoclonal antibodies.
- •Less than 4 weeks since prior chemotherapy counted from 1st day of treatment regimen.
- •Pregnancy or lactation.
- •HIV or HTLV-I positively.
- •Serum creatinine >1.6mg/dl or serum bilirubin >1.5mg/dl unless due to tumor.
- •Pulmonary function tests (PFTs) -OLCO<50%, cardiac EF <50% of predicted levels.
- •Patient with severe concomitant medical or psychiatric illness.
研究组 & 干预措施
Campath in Nonmyeloablative Transplantation
Campath-1 H Starting Dose of 15 mg by vein daily, 3 days in a row + Fludarabine 30 mg/m2 by vein daily, 3 days in a row + Cyclophosphamide 1 gm/m2 by vein daily, 3 days in a row + Rituximab 375 mg/m2 by vein, given 8 days before transplant then weekly for 4 total doses.
干预措施: Campath-1 H (Alemtuzumab) (Drug)
Campath in Nonmyeloablative Transplantation
Campath-1 H Starting Dose of 15 mg by vein daily, 3 days in a row + Fludarabine 30 mg/m2 by vein daily, 3 days in a row + Cyclophosphamide 1 gm/m2 by vein daily, 3 days in a row + Rituximab 375 mg/m2 by vein, given 8 days before transplant then weekly for 4 total doses.
干预措施: Fludarabine (Drug)
Campath in Nonmyeloablative Transplantation
Campath-1 H Starting Dose of 15 mg by vein daily, 3 days in a row + Fludarabine 30 mg/m2 by vein daily, 3 days in a row + Cyclophosphamide 1 gm/m2 by vein daily, 3 days in a row + Rituximab 375 mg/m2 by vein, given 8 days before transplant then weekly for 4 total doses.
干预措施: Cyclophosphamide (Drug)
Campath in Nonmyeloablative Transplantation
Campath-1 H Starting Dose of 15 mg by vein daily, 3 days in a row + Fludarabine 30 mg/m2 by vein daily, 3 days in a row + Cyclophosphamide 1 gm/m2 by vein daily, 3 days in a row + Rituximab 375 mg/m2 by vein, given 8 days before transplant then weekly for 4 total doses.
干预措施: Rituximab (Drug)
结局指标
主要结局
Number of Participants Surviving 100 days post-transplant
时间窗: 30 Day Engraftment (Baseline) to 100 Days post-transplant
次要结局
未报告次要终点