A Phase II Study of Non-myeloablative Allogeneic Transplantation Using Total Lymphoid Irradiation (TLI) and Antithymocyte Globulin (ATG) In Patients With Cutaneous T Cell Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Progression-Free Survival (PFS) at 180 Days
研究概览
简要总结
Non-myeloablative approach for allogeneic transplant is a reasonable option, especially given that the median age at diagnosis is 55-60 years and frequently present compromised skin in these patients, which increases the risk of infection. Therefore, we propose a clinical study with allogeneic hematopoietic stem cell transplantation (HSCT) using a unique non-myeloablative preparative regimen, TLI/ATG, to treat advanced mycosis fungoides/Sezary syndrome (MF/SS).
详细描述
Primary Objectives
-To evaluate the graft versus lymphoma effect by monitoring rate of clinical response, event-free and overall survival.
Secondary Objectives
-To evaluate the incidence and extent of acute and chronic graft-versus-host disease (GVHD) and time to engraftment.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stage IIB-IV mycosis fungoides or Sezary syndrome, who have failed at least 1 standard systemic therapy or are not candidates for standard therapy.
- •Pathology reviewed and the diagnosis confirmed at Stanford University Medical Center.
- •Age > 18 years and <= 75 years.
- •Karnofsky Performance Status >= 70%.
- •Corrected DLCO >= 40%
- •Left ventricle ejection fraction (LVEF) > 30%.
- •ALT and AST must be <= 3X normal. Total bilirubin <= 3 mg/dL unless hemolysis or Gilbert's disease.
- •Estimated creatinine clearance >= 50 ml/min.
- •Have a related or unrelated HLA-identical donor or one antigen/allele mismatched in HLA-A, B, C or DRB
- •Signed informed consent.
- •Patients with prior malignancies diagnosed > 5 years ago without evidence of disease are eligible.
- •Patients with a prior malignancy treated < 5 years ago but have a life expectancy of > 5 years for that malignancy are eligible.
- •Donor Inclusion Criteria
- •HIV seronegative.
- •No contraindication to the administration of G-CSF.
- •Willing to have a central venous catheter placed for apheresis if peripheral veins are inadequate
排除标准
- •Uncontrolled active infection.
- •Uncontrolled congestive heart failure or angina.
- •Pregnancy or nursing patients will be excluded from the study.
- •Those who are HIV-positive will be excluded from the study due to high risk of lethal infection after hematopoietic cell transplantation.
- •Donor Exclusion Criteria
- •Serious medical or psychological illness.
- •Pregnant or lactating women are not eligible
- •Prior malignancies within the last 5 years except for non-melanoma skin cancers
研究组 & 干预措施
Total lymphoid irradiation & anti-thymocyte immunoglobulin
TLI is administered from a 6 MeV linear accelerator in 80c- 120c Gy fractions. Anti-thymocyte-Globulin (ATG) is administered intravenously for a total dose of 7.5 mg/kg.
干预措施: anti-thymocyte globulin (Drug)
Total lymphoid irradiation & anti-thymocyte immunoglobulin
TLI is administered from a 6 MeV linear accelerator in 80c- 120c Gy fractions. Anti-thymocyte-Globulin (ATG) is administered intravenously for a total dose of 7.5 mg/kg.
干预措施: cyclosporine (Drug)
Total lymphoid irradiation & anti-thymocyte immunoglobulin
TLI is administered from a 6 MeV linear accelerator in 80c- 120c Gy fractions. Anti-thymocyte-Globulin (ATG) is administered intravenously for a total dose of 7.5 mg/kg.
干预措施: Lymphoid radiation (Radiation)
结局指标
主要结局
Progression-Free Survival (PFS) at 180 Days
时间窗: 180 days
Progression-Free Survival (PFS; time to disease progression or death from any cause) assessed at 180 days (Kaplan-Meier estimate). Disease progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
次要结局
- Treatment Related Mortality(Up to 5 years)
- Number of Participants With Acute Graft-versus-host Disease (GVHD)(6 months)
- Mortality(Up to 5 years)
- Event Free Survival (EFS)(5 years)
- Number of Participants With Chronic Graft-versus-host Disease (GVHD)(2 years)
- Overall Survival (OS)(5 years)
研究者
Wen-Kai Weng
Associate Professor of Medicine
Stanford University