A Phase II Study of MOAD (Methotrexate, Vincristine, L-asparaginase and Dexamethasone) With Subcutaneous Campath for Adults With Relapsed or Refractory Acute Leukemia (ALL)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 58
- 主要终点
- Complete Response Rate
研究概览
简要总结
This phase II trial is studying how well giving combination chemotherapy together with alemtuzumab works in treating patients with relapsed or refractory acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Monoclonal antibodies, such as alemtuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving combination chemotherapy together with alemtuzumab may kill more cancer cells.
详细描述
OBJECTIVES:
I. Determine the complete response rate in patients with relapsed or refractory acute lymphoblastic leukemia treated with methotrexate, vincristine, asparaginase, and dexamethasone (MOAB) in combination with alemtuzumab.
II. Determine disease-free and/or overall survival of patients treated with this regimen.
III. Determine the toxic effects of this regimen in these patients.
IV. Correlate the density of cluster of differentiation 52 (CD52) molecules on the surface of leukemic lymphoblasts with response in patients treated with this regimen.
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
- •Refractory or relapsed acute lymphoblastic leukemia
- •Must be in first relapse or have failed to achieve complete remission with 1 prior regimen
- •Prior central nervous system (CNS) leukemia allowed provided cerebrospinal fluid is normal
- •ECOG Performance status of 0-3
- •Bilirubin normal
- •Creatinine normal
- •Human immunodeficiency virus (HIV) negative
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •Exclusion criteria:
- •Hepatitis B positivity
- •Bacterial or fungal infection
- •Infection requiring treatment with antibiotics
- •Active cytomegalovirus infection by molecular detection methods
- •Known hypersensitivity to alemtuzumab or its components
- •Pregnant or nursing
- •Other malignancy within the past 5 years except adequately treated basal cell skin cancer or cervical carcinoma
排除标准
- 未提供
研究组 & 干预措施
Treatment (chemotherapy, enzyme inhibitor therapy)
INDUCTION THERAPY: Patients receive methotrexate IV; vincristine IV and asparaginase IM ; oral dexamethasone ; and alemtuzumab SC.
CONSOLIDATION THERAPY: Patients receive methotrexate IV and asparaginase IM.
CYTOREDUCTION THERAPY: Patients receive vincristine IV and methotrexate IV; leucovorin calcium IV; and oral dexamethasone.
MAINTENANCE THERAPY: Patients receive oral mercaptopurine; oral methotrexate; vincristine IV; and oral dexamethasone.
干预措施: alemtuzumab (Biological)
Treatment (chemotherapy, enzyme inhibitor therapy)
INDUCTION THERAPY: Patients receive methotrexate IV; vincristine IV and asparaginase IM ; oral dexamethasone ; and alemtuzumab SC.
CONSOLIDATION THERAPY: Patients receive methotrexate IV and asparaginase IM.
CYTOREDUCTION THERAPY: Patients receive vincristine IV and methotrexate IV; leucovorin calcium IV; and oral dexamethasone.
MAINTENANCE THERAPY: Patients receive oral mercaptopurine; oral methotrexate; vincristine IV; and oral dexamethasone.
干预措施: asparaginase (Drug)
Treatment (chemotherapy, enzyme inhibitor therapy)
INDUCTION THERAPY: Patients receive methotrexate IV; vincristine IV and asparaginase IM ; oral dexamethasone ; and alemtuzumab SC.
CONSOLIDATION THERAPY: Patients receive methotrexate IV and asparaginase IM.
CYTOREDUCTION THERAPY: Patients receive vincristine IV and methotrexate IV; leucovorin calcium IV; and oral dexamethasone.
MAINTENANCE THERAPY: Patients receive oral mercaptopurine; oral methotrexate; vincristine IV; and oral dexamethasone.
干预措施: methotrexate (Drug)
Treatment (chemotherapy, enzyme inhibitor therapy)
INDUCTION THERAPY: Patients receive methotrexate IV; vincristine IV and asparaginase IM ; oral dexamethasone ; and alemtuzumab SC.
CONSOLIDATION THERAPY: Patients receive methotrexate IV and asparaginase IM.
CYTOREDUCTION THERAPY: Patients receive vincristine IV and methotrexate IV; leucovorin calcium IV; and oral dexamethasone.
MAINTENANCE THERAPY: Patients receive oral mercaptopurine; oral methotrexate; vincristine IV; and oral dexamethasone.
干预措施: dexamethasone (Drug)
Treatment (chemotherapy, enzyme inhibitor therapy)
INDUCTION THERAPY: Patients receive methotrexate IV; vincristine IV and asparaginase IM ; oral dexamethasone ; and alemtuzumab SC.
CONSOLIDATION THERAPY: Patients receive methotrexate IV and asparaginase IM.
CYTOREDUCTION THERAPY: Patients receive vincristine IV and methotrexate IV; leucovorin calcium IV; and oral dexamethasone.
MAINTENANCE THERAPY: Patients receive oral mercaptopurine; oral methotrexate; vincristine IV; and oral dexamethasone.
干预措施: leucovorin calcium (Drug)
Treatment (chemotherapy, enzyme inhibitor therapy)
INDUCTION THERAPY: Patients receive methotrexate IV; vincristine IV and asparaginase IM ; oral dexamethasone ; and alemtuzumab SC.
CONSOLIDATION THERAPY: Patients receive methotrexate IV and asparaginase IM.
CYTOREDUCTION THERAPY: Patients receive vincristine IV and methotrexate IV; leucovorin calcium IV; and oral dexamethasone.
MAINTENANCE THERAPY: Patients receive oral mercaptopurine; oral methotrexate; vincristine IV; and oral dexamethasone.
干预措施: mercaptopurine (Drug)
Treatment (chemotherapy, enzyme inhibitor therapy)
INDUCTION THERAPY: Patients receive methotrexate IV; vincristine IV and asparaginase IM ; oral dexamethasone ; and alemtuzumab SC.
CONSOLIDATION THERAPY: Patients receive methotrexate IV and asparaginase IM.
CYTOREDUCTION THERAPY: Patients receive vincristine IV and methotrexate IV; leucovorin calcium IV; and oral dexamethasone.
MAINTENANCE THERAPY: Patients receive oral mercaptopurine; oral methotrexate; vincristine IV; and oral dexamethasone.
干预措施: vincristine (Drug)
结局指标
主要结局
Complete Response Rate
时间窗: assessed before the first consolidation cycle and first cytoreduction cycle, before the first and after the last maintenance cycle; after discontinuing treatment, assessed every 3 months if < 2 years and every 6 months if 2-5 years from study entry
Complete response requires that all of the following be present for at least four weeks. 1. Peripheral Blood Counts: Neutrophil count \>= 1.0 x 109/L, Platelet count \>= 100 x 109/L, Reduced hemoglobin concentration or hematocrit has no bearing on remission status, Leukemic blasts must not be present in the peripheral blood. 2 .Bone Marrow Aspirate and Biopsy: Cellularity of bone marrow biopsy must be \> 20% with maturation of all cell lines, \<= 5% blasts. 3. Extramedullary leukemia, such as CNS or soft tissue involvement, must not be present.
次要结局
- Overall Survival(assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry)