NCT00093587Unknown不适用
Pilot Trial of Two Dose Levels of Thymoglobulin® as Part of a Myeloablative-Conditioning for a HLA Identical Matched Related Donor (MRD) Stem Cell Transplant With Cyclosporine (CsA) as Posttransplant Graft vs Host Disease (GvHD) Prophylaxis
适应症
相关药物
试验速览
- 阶段
- 不适用
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Giving chemotherapy and total-body irradiation before a donor bone marrow transplant or peripheral blood 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. 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 antithymocyte globulin before transplant and cyclosporine after transplant may stop this from happening.
PURPOSE: This randomized clinical trial is studying how well giving antithymocyte globulin together with cyclosporine works in preventing graft-versus-host disease in patients who are undergoing chemotherapy with or without radiation therapy followed by donor stem cell transplant for acute lymphoblastic leukemia or acute myeloid leukemia.
详细描述
OBJECTIVES:
Primary
- Compare the incidence of acute graft-vs-host disease (GVHD) within the first 100 days after transplantation in patients with acute lymphoblastic leukemia or acute myeloid leukemia treated with a myeloablative conditioning regimen comprising cyclophosphamide (with or without radiotherapy) and low- vs high-dose anti-thymocyte globulin followed by allogeneic HLA-matched related stem cell transplantation and cyclosporine.
- Compare the incidence of serious adverse events within the first 100 days after transplantation in patients treated with these regimens.
Secondary
- Compare 100-day and 6-month survival in patients treated with these regimens.
- Compare the severity of acute GVHD in patients treated with these regimens.
- Compare the incidence of culture-proven infections at 100 days and 6 months after transplantation in patients treated with these regimens.
- Compare the incidence of mucositis, in terms of presence, severity, and duration, in patients treated with these regimens.
- Compare the number of days on opiate drugs within the first 30 days after transplantation in patients treated with these regimens.
- Compare the time to engraftment in patients treated with these regimens.
- Compare the incidence of hospitalization within the first 6 months after transplantation, in terms of length of initial stay, cumulative total days, and number of hospitalizations, in patients treated with these regimens.
- Compare the relapse rate and time to relapse in patients treated with these regimens.
- Compare the incidence and severity of chronic GVHD between 100 days and 6 months after transplantation in patients treated with these regimens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Confirmed diagnosis of acute myeloid leukemia (AML) or acute lymphoblastic leukemia
- •In first complete remission or second complete remission
- •Secondary AML allowed
- •HLA-A, -B, and -DRB1 identical related donor available AND must be fully matched at Class II by high-resolution molecular HLA typing (at least 4 digits)
- •Currently receiving a myeloablative conditioning regimen that includes cyclophosphamide
- •All patients from a center should receive the same conditioning regimen throughout the study
- •No fludarabine or other purine analogues (e.g. cladribine or pentostatin) as part of conditioning regimen
- •No uncontrolled CNS disease
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Not specified
- •Bilirubin < 2 mg/dL
- •ALT and/or AST ≤ 3 times normal
- •Creatinine < 2.0 mg/dL OR
- •Creatinine clearance > 50 mL/min
- •Cardiovascular
- •Ejection fraction > 40%
- •No severe cardiac disease
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No known contraindication to administration of rabbit anti-thymocyte globulin
- •No current drug or alcohol abuse
- •No significant medical or psychosocial problem or unstable disease state (including, but not limited to, morbid obesity) that would preclude study participation
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No prior or concurrent bone marrow transplantation from a donor who has positive serology for HIV, hepatitis B virus, hepatitis C virus, or syphilis
- •No IV immunoglobulin prior to engraftment
- •No concurrent ex vivo engineered or processed graft (CD34+ enrichment or T-cell depletion)
- •Chemotherapy
- •See Disease Characteristics
- •No prior or concurrent methotrexate for graft-vs-host disease prophylaxis
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •Not specified
- •Not specified
- •More than 30 days since prior experimental agents
- •No other concurrent investigational agents
- •Enrollment in investigational studies (i.e., anti-microbial agents) allowed only for life threatening events or after exhausting other treatment modalities
排除标准
- 未提供
研究者
研究点 (1)
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