Campath 1H (Alemtuzumab) Combined With High-Dose Therapy and Autologous Stem Cell Transplantation in Chronic Lymphocytic Leukemia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 12
- 主要终点
- Safety and feasibility of CAMPATH-1H included into the myeloablative regimen (cyclophosphamide and TBI) of the CLL3 protocol monitoring of treatment related mortality and morbidity (CTC scale) continuous
研究概览
简要总结
RATIONALE: Giving combination chemotherapy before a peripheral blood stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as G-CSF, and certain chemotherapy drugs, helps stem cells move from the bone marrow to the blood so they can be collected and stored. A monoclonal antibody, such as alemtuzumab, is given to kill any remaining cancer cells. Chemotherapy and radiation therapy (total-body irradiation) are given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy and radiation therapy. Giving combination chemotherapy, total-body irradiation, and alemtuzumab together with autologous peripheral stem cell transplant may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with total-body irradiation and alemtuzumab works in treating patients undergoing an autologous stem cell transplant for stage I, stage II, stage III, or stage IV chronic lymphocytic leukemia.
详细描述
OBJECTIVES:
Primary
- Determine the safety and feasibility of cytoreductive fludarabine and cyclophosphamide followed by high-dose myeloablative therapy comprising total-body irradiation, cyclophosphamide, and alemtuzumab in patients undergoing autologous filgrastim (G-CSF)-mobilized peripheral blood stem cell transplantation for stage I-IV chronic lymphocytic leukemia.
Secondary
- Determine the clinical and molecular remission rate and duration in patients treated with this regimen.
- Determine the overall survival of patients treated with this regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Chronic lymphocytic leukemia (CLL), meeting 1 of the following stage criteria:
- •Stage I-IV disease
- •Binet stage B or C disease
- •Binet stage A disease at high risk for rapid disease progression, as defined by both of the following criteria:
- •Nonnodular marrow infiltration and/or lymphocyte doubling time < 12 months
- •Thymidine kinase > 7.0 U/L and/or ß-2-microglobulin > 3.5 mg/L
- •Polymerase chain reaction-amplifiable clonal CDR III rearrangement of the immunoglobulin variable heavy chain gene
- •No Richter's syndrome or B-prolymphocytic leukemia
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-1
- •No concurrent disease resulting in major organ dysfunction
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •No other concurrent malignancy
- •No New York Heart Association class III or IV cardiac failure
- •No cardiomyopathy
- •No history of myocardial infarction
- •No symptomatic coronary heart disease
- •No severe cardiac arrhythmia
- •No severe or uncontrolled hypertension
- •No chronic pulmonary disease
- •No pulmonary function test impairment
- •No severe or uncontrolled diabetes mellitus
- •Bilirubin or transaminases ≤ 1.5 times upper limit of normal
- •Creatinine ≤ 1.4 mg/dL
- •No cerebral dysfunction
- •No severe psychiatric impairment
- •No drug addiction or alcoholism
- •Negative HIV
- •Negative Hepatitis B or C
- •No allergy to any of the protocol drugs
- •No history of anaphylactic reaction to monoclonal antibodies
- •No active infection
- •PRIOR CONCURRENT THERAPY:
- •No more than 1 prior chemotherapy regimen OR chemotherapy that lasted > 6 months
- •No prior radiotherapy
- •No prior treatment with alemtuzumab
- •No prior long-term (> 1 month) systemic corticosteroids
- •No prior therapy with dexamethasone, carmustine, etoposide, cytarabine, and melphalan (Dexa-BEAM)
排除标准
- 未提供
结局指标
主要结局
Safety and feasibility of CAMPATH-1H included into the myeloablative regimen (cyclophosphamide and TBI) of the CLL3 protocol monitoring of treatment related mortality and morbidity (CTC scale) continuous
次要结局
- Rate and duration of molecular responses MRD levels continuous
- Rate and duration of clinical remissions NCIE sponsored remission criteria for CLL continuous
- Overall survival time from treatment to death continuous