NCT00043381已完成3 期
A Randomized, Open-label, Phase III Trial of Decitabine (5-aza-2'Deoxycytidine) Versus Supportive Care in Adults With Advanced-stage Myelodysplastic Syndrome
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 24
研究概览
简要总结
To compare the safety and efficacy profiles of decitabine to those of supportive care in adults with advanced-stage myelodysplastic syndrome (MDS)
详细描述
This experimental (investigational) study is intended to answer the question of whether decitabine is any better than supportive care alone in delaying progression (worsening) of the disease, prolonging survival or improving the overall quality of life for MDS patients who are not candidates for bone marrow transplant (BMT).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •MDS (de novo or secondary) fitting any of the recognized French-American-British, FAB, classifications or chronic myelomonocytic leukemia (CMML) with WBC < 12,000/mm3, AND International Prognostic Scoring System (IPSS) >/= 0.5 as determined by CBC, bone marrow assessment and bone marrow cytogenetics within 30 days of randomization
- •18 years or older
- •Female patients of child-bearing potential must have a negative serum hCG within 24 hours prior to randomization, must practice a medically approved method of birth control for the past 30 days, and agree to continue this practice for the trial duration and must not be breast-feeding
- •ECOG or WHO performance status of 0-2
- •Written informed consent
- •Normal renal and hepatic function (creatinine </= 2 mg/dL, bilirubin </= 1.5 mg/dL, SGPT </= 2 times the upper limit of normal range)
排除标准
- •Acute Myeloid Leukemia (AML) (>/=30% bone marrow blasts) or other progressive malignant disease
- •Patients must have recovered from the toxic effects of prior therapy and must be off all chemotherapy for a minimum of 4 weeks prior to study entry to the protocol (a minimum of six weeks for prior nitrosoureas and bone marrow transplantation)
- •Ongoing treatment with androgenic hormones, danazol, colony-stimulating factors, or other agents used to treat MDS within 7 days of study initiation.
- •Administration of any investigational agent within the 30 days preceding study initiation.
- •Uncontrolled cardiac disease or congestive heart failure
- •Uncontrolled restrictive or obstructive pulmonary disease
- •Active viral or bacterial infection
- •Superimposed autoimmune hemolytic anemia or thrombocytopenia
- •Known positive serology for HIV
- •Mental illness or other condition preventing full cooperation with the treatment and monitoring requirements of the study.
研究者
研究点 (24)
Loading locations...
相似试验
已完成
3 期
An Effectiveness and Safety Study of Decitabine in Patients With Myelodysplastic SyndromeMyelodysplastic SyndromeNCT01751867Xian-Janssen Pharmaceutical Ltd.135
招募中
1 期
Decitabine Alone or in Combination With Venetoclax, Gilteritinib, Enasidenib, or Ivosidenib as Maintenance Therapy for the Treatment of Acute Myeloid Leukemia in RemissionAcute Myeloid LeukemiaNCT05010772M.D. Anderson Cancer Center125
Unknown
3 期
Decitabine in Combination With Low-dose Cytarabine in Elderly Patients With Acute Myeloid LeukemiaAcute Myeloid Leukemia, AdultNCT02985372Chunyan Ji30
已完成
1 期
Decitabine, Doxorubicin, and Cyclophosphamide in Treating Children With Relapsed or Refractory Solid Tumors or NeuroblastomaRecurrent NeuroblastomaUnspecified Childhood Solid Tumor, Protocol SpecificNCT00075634National Cancer Institute (NCI)21
Unknown
3 期
Study of Decitabine Combined With HAAG Regimen in Newly Diagnosed ETP-ALL/LBL, T/M-MPAL and ALL/LBL With Myeloid or Stem Cell Markers PatientsInduction ChemotherapyAcute T-Lymphocytic LeukemiaT-cell Lymphoblastic Lymphoma LeukemiaT-cell/Myeloid Mixed Phenotype Acute LeukemiaNCT04446130The First Affiliated Hospital of Soochow University100