A Phase II Study of Reduced Intensity Sibling Allogeneic Transplantation for Relapsed, Chemosensitive, PET-positive Hodgkin Lymphoma
试验速览
- 阶段
- 2 期
- 入组人数
- 49
- 主要终点
- 3-year progression-free survival
研究概览
简要总结
RATIONALE: Giving chemotherapy before a donor stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. Also, monoclonal antibodies, such as alemtuzumab, can find cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclosporine before and after the transplant may stop this from happening. Once the donated stem cells begin working, the patient's immune system may see the remaining cancer cells as not belonging in the patient's body and destroy them (called graft-versus-tumor effect). Giving an infusion of the donor's white blood cells (donor lymphocyte infusion) may boost this effect.
PURPOSE: This phase II trial is studying the side effects of fludarabine phosphate, melphalan, and alemtuzumab followed by donor stem cell transplant in treating patients with relapsed Hodgkin lymphoma.
详细描述
OBJECTIVES:
- To document the toxicity, feasibility, and survival after reduced-intensity conditioning followed by allogeneic hematopoietic stem cell transplantation from a matched sibling donor in patients with relapsed, chemosensitive Hodgkin lymphoma.
OUTLINE: This is a multicenter study.
- Reduced-intensity conditioning: Patients receive fludarabine phosphate IV on days -7 to -3, melphalan IV over 30 minutes on day -2, and alemtuzumab IV on day -1.
- Transplantation: Patients undergo donor stem cell infusion on day 0.
- Graft-vs-host disease (GVHD) prophylaxis: Patients receive cyclosporine IV or orally on days -1 to 60, followed by a taper until 3 months post-transplantation, in the absence of GVHD.
- Donor-lymphocyte infusion (DLI): DLI is used for the eradication of mixed chimerism and for the management of residual or relapsed disease. If necessary, patients undergo DLI every 3 months until the desired endpoint is achieved or GVHD develops.
After completion of study therapy, patients are followed up every 3 months for 3 years.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Confirmed diagnosis of Hodgkin lymphoma, meeting all of the following criteria:
- •Achieved partial or complete remission (using standard criteria) after salvage chemotherapy
- •Relapsed after first remission with residual fludeoxyglucose F 18-avid lesions
- •Available HLA-matched sibling donor
- •PATIENT CHARACTERISTICS:
- •WHO performance status 0-1
- •Creatinine clearance ≥ 50 mL/min (measured by EDTA clearance or 24-hour urine collection)
- •Serum bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •Alkaline phosphatase ≤ 2 times ULN
- •LVEF ≥ 40%
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 2 months (or 3 months for women) after completion of study therapy
- •No other malignancy within the past 5 years except for nonmelanoma skin tumors or stage 0 (in situ) cervical carcinoma
- •No HIV positivity
- •No symptomatic respiratory compromise
- •No concurrent serious medical condition that would preclude transplantation
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •No prior high-dose therapy or allograft
排除标准
- 未提供
结局指标
主要结局
3-year progression-free survival
次要结局
- Donor engraftment rates, including chimerism at 3 and 6 months
- Non-relapse mortality at 100 days and at 1 and 2 years post-transplant
- Incidence of grade II-IV toxicity as assessed by NCI CTCAE v3.0
- Incidence, severity, and timing of graft-vs-host disease
- Response rates
- Relapse rates
- Response to donor lymphocyte infusions
- Overall survival