Phase II Study of Maintenance Therapy With Decitabine (NSC #127716) Following Standard Induction and Cytogenetic Risk-Adapted Intensification in Previously Untreated Patients With AML < 60 Years
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 546
- 试验地点
- 46
- 主要终点
- Number of Participants Who Completed Maintenance Decitabine.
研究概览
简要总结
This phase II trial is studying the side effects and how well decitabine works when given as maintenance therapy after standard therapy in treating patients with previously untreated acute myeloid leukemia. Drugs used in chemotherapy, such as cytarabine, daunorubicin, etoposide, busulfan, and decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving decitabine as maintenance therapy after standard therapy may keep cancer cells from coming back.
详细描述
PRIMARY OBJECTIVES:
I. To determine the efficacy, feasibility, and toxicities when one year of maintenance therapy with decitabine is given to patients < 60 years with untreated acute myeloid leukemia (AML) who achieve and maintain first complete remission (CR) following an established induction and intensification regimen.
II. To determine the 1-year disease free survival rate for AML patients in first CR treated with maintenance decitabine.
SECONDARY OBJECTIVES:
I. To measure biologic response to decitabine in evaluable patients with fusion genes to determine eradication of minimal residual disease.
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
- 15 Years 至 59 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unequivocal histologic diagnosis of AML (> 20% blasts in the bone marrow based on the World Health Organization [WHO] and/or French American British [FAB] classifications), excluding M3 (acute promyelocytic leukemia); patients with antecedent myelodysplasia are eligible for treatment on this trial only if there were no bone marrow biopsy showing myelodysplastic syndrome (MDS) > 3 months prior to enrollment; patients with therapy-related AML are eligible if they have been free of their primary disease and have not received any chemotherapy for at least 2 years
- •No prior 5-azacitidine or decitabine therapy
- •No prior treatment for leukemia or myelodysplastic syndrome with four permissible exceptions:
- •Emergency leukapheresis
- •Emergency treatment for hyperleukocytosis with hydroxyurea
- •Cranial radiation therapy (RT) for central nervous system (CNS) leukostasis (one dose only)
- •Growth factor/cytokine support
排除标准
- 未提供
研究组 & 干预措施
Treatment (chemotherapy, PBSC or bone marrow transplantation)
See Detailed Description.
干预措施: Autologous Bone Marrow Transplantation (Procedure)
Treatment (chemotherapy, PBSC or bone marrow transplantation)
See Detailed Description.
干预措施: Autologous Hematopoietic Stem Cell Transplantation (Procedure)
Treatment (chemotherapy, PBSC or bone marrow transplantation)
See Detailed Description.
干预措施: Busulfan (Drug)
Treatment (chemotherapy, PBSC or bone marrow transplantation)
See Detailed Description.
干预措施: Cytarabine (Drug)
Treatment (chemotherapy, PBSC or bone marrow transplantation)
See Detailed Description.
干预措施: Daunorubicin Hydrochloride (Drug)
Treatment (chemotherapy, PBSC or bone marrow transplantation)
See Detailed Description.
干预措施: Decitabine (Drug)
Treatment (chemotherapy, PBSC or bone marrow transplantation)
See Detailed Description.
干预措施: Etoposide (Drug)
Treatment (chemotherapy, PBSC or bone marrow transplantation)
See Detailed Description.
干预措施: Filgrastim (Biological)
Treatment (chemotherapy, PBSC or bone marrow transplantation)
See Detailed Description.
干预措施: Laboratory Biomarker Analysis (Other)
Treatment (chemotherapy, PBSC or bone marrow transplantation)
See Detailed Description.
干预措施: Pharmacological Study (Other)
结局指标
主要结局
Number of Participants Who Completed Maintenance Decitabine.
时间窗: Up to 5 years
To determine feasibility of decitabine maintenance, this outcome measures the number of participants who completed all 8 planned cycles of decitabine maintenance as per protocol.
Disease-free Survival (DFS) Rate at 1 Year
时间窗: At 1 year
For participants who achieved a complete remission (CR), this is the percentage of participants who were alive and relapse free at 1 year. The 1 year rate, with 95% confidence interval, was estimated using the Kaplan-Meier method A CR is defined as those with \> 20% cellularity of bone marrow biopsy, no presence of extramedullary leukemia for AML, \<5 % myeloblast cells for bone marrow with peripheral blood and normal complete blood count (absolute neutrophils \> 1000 mL and platelets \>= 100,000 mL).
次要结局
未报告次要终点