Study of Allogeneic Transplantation in Patients With Cutaneous T-Cell Lymphoma (CTCL)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Participant's Response According to Physician's Global Assessment of Clinical Condition (PGA)
研究概览
简要总结
The goal of this clinical research study is to see if receiving a transplant of blood stem cells (cells that can produce blood) or bone marrow from either a related donor (brother, sister or other relative) or an unrelated voluntary donor will help patients with advanced cutaneous T-cell lymphoma. The length of time that patients who receive the treatment remain free of disease will also be studied.
详细描述
You will receive the chemotherapy drug fludarabine for 5 days (Days 1 to 5). The drug melphalan will be given on Days 4 and 5. You may also receive the drug anti-thymocyte globulin (ATG) on Days 4, 5, 6. This will be followed by infusion of blood stem cells or bone marrow from a donor on Day 7. A separate consent will be provided to the donor. The donor can be a brother, sister or another family member or a compatible unrelated donor. The drugs and the stem cells will be given through a catheter (a small tube) placed under the collarbone. You may receive your treatment on an inpatient or outpatient basis. If treated on an inpatient basis, you will stay in the hospital during treatment and recovery, which can take 4 to 5 weeks even if there are no complications.
The chemotherapy and the ATG are given to help the body accept the transplanted stem cells or bone marrow. You will receive antibiotics to fight infection and a medicine called G-CSF (Neupogen®) to help blood counts rise back to healthier levels. G-CSF is given as an injection under the skin. You will also need blood and platelet transfusions.
You will be given standard drugs to help decrease the risk of side effects. You may ask the study staff for information about how the drugs are given and their risks.
If the cancer grows and graft-versus-host disease is not present, you may be eligible to receive donor blood cells (lymphocytes) infused through the catheter. This may cause graft-versus-host disease and may help shrink the cancer. If the cancer grows and graft-versus-host disease is already present, then donor lymphocytes are not given.
Sometimes, the body rejects the donor cells; this reaction is called "graft rejection". Sometimes the donor cells attack the body, a reaction called graft-versus-host disease (GvHD). The drugs tacrolimus and methotrexate will be given to help prevent these reactions from occurring. These drugs are given through a vein or by mouth before and/or after the transplant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Patients with pathologically proven cutaneous T-cell lymphoma (CTCL), disease stage IIB to IVB, patients must be in at least a partial response-PR (skin and lymph nodes) after receiving other non-allogeneic transplant therapy, age </= 70 years, Zubrod performance status 0 or 1, left ventricular ejection fraction >/= 50% or approved for transplant by a cardiologist, DLCO >/= 50% predicted or approved for transplant by a pulmonologist, serum creatinine </= 1.5 mg/dL, serum bilirubin < 2mg/dL. SGPT < 3 x upper limit of normal, and no previous history of allogeneic transplantation.
- •Donor: HLA-compatible related (HLA-A, -B, -DRB1 matched or with one-antigen mismatch) or HLA-compatible unrelated (HLA-A, -B, -C and -DRB1 matched or with one-antigen mismatch).
排除标准
- •Patients cannot have active central nervous system (CNS) disease.
研究组 & 干预措施
Fludarabine + Melphalan with PBPC
Fludarabine 25 mg/m^2 intravenous (IV) daily for 5 Days prior to Allogeneic Transplant, Melphalan 70 mg/m^2 IV daily for 2 Days prior to IV Allogeneic Transplant following Fludarabine & Melphalan. Thymoglobulin 2 mg/kg/day IV on days -3, -2 & -1 for patients receiving matched unrelated marrow/stem cells or mismatched related marrow.
干预措施: Fludarabine (Drug)
Fludarabine + Melphalan with PBPC
Fludarabine 25 mg/m^2 intravenous (IV) daily for 5 Days prior to Allogeneic Transplant, Melphalan 70 mg/m^2 IV daily for 2 Days prior to IV Allogeneic Transplant following Fludarabine & Melphalan. Thymoglobulin 2 mg/kg/day IV on days -3, -2 & -1 for patients receiving matched unrelated marrow/stem cells or mismatched related marrow.
干预措施: Melphalan (Drug)
Fludarabine + Melphalan with PBPC
Fludarabine 25 mg/m^2 intravenous (IV) daily for 5 Days prior to Allogeneic Transplant, Melphalan 70 mg/m^2 IV daily for 2 Days prior to IV Allogeneic Transplant following Fludarabine & Melphalan. Thymoglobulin 2 mg/kg/day IV on days -3, -2 & -1 for patients receiving matched unrelated marrow/stem cells or mismatched related marrow.
干预措施: Allogeneic Transplant (Procedure)
Fludarabine + Melphalan with PBPC
Fludarabine 25 mg/m^2 intravenous (IV) daily for 5 Days prior to Allogeneic Transplant, Melphalan 70 mg/m^2 IV daily for 2 Days prior to IV Allogeneic Transplant following Fludarabine & Melphalan. Thymoglobulin 2 mg/kg/day IV on days -3, -2 & -1 for patients receiving matched unrelated marrow/stem cells or mismatched related marrow.
干预措施: Thymoglobulin (Drug)
结局指标
主要结局
Participant's Response According to Physician's Global Assessment of Clinical Condition (PGA)
时间窗: Response assessed pre-transplant and 100 days post transplant with follow up at 1 year.
Response defined by Physician's Global Assessment of Clinical Condition (PGA) where Complete Response (CR) is No evidence of disease; 100% improvement; Partial Response (PR), one of following: 1) Very significant clearance ( \> 90% to \< 100%); only traces of disease remains; 2) Significant improvement ( \> 75% to \< 90%); some evidence of disease remain; 3) Intermediate between slight and marked improvement; ( \> 50% to \< 75%); 4) Some improvement ( \> 25% to \< 50%); however, significant evidence of disease remains; Stable Disease (SD): Disease has not changed from baseline condition (+\<25%); Progressive Disease (PD): Disease is worse than at baseline evaluation by \> 25% or more. Response confirmed by a second assessment at least 4 weeks following it. Assessments at baseline, pre and post transplant (100 days) then till disease progression or year one.
次要结局
- Average Overall Survival (OS) Length(Baseline to disease progression, followed up to 5 years post transplant)