NCT05413018进行中（未招募）2 期
A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Compare Efficacy and Safety of Oral Azacitidine (CC-486) Plus Best Supportive Care Versus Best Supportive Care as Maintenance Therapy in Chinese Patients With Acute Myeloid Leukemia in Complete Remission
Bristol-Myers Squibb63 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2022年8月19日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 34
- 试验地点
- 63
- 主要终点
- Relapse-free survival (RFS)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Oral Azacitidine (CC-486) in Chinese participants with acute myeloid leukemia in complete remission.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed, histologically confirmed de novo acute myeloid leukemia (AML) or AML secondary to prior myelodysplastic disease or chronic myelomonocytic leukemia (CMML)
- •Eastern cooperative oncology group performance status of 0, 1, or 2
- •Has undergone induction therapy with intensive chemotherapy with or without consolidation therapy
- •Must have achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) status within 6 months (+/- 7 days) prior to starting study therapy
排除标准
- •Suspected or proven acute promyelocytic leukemia or acute myeloid leukemia with previous hematologic disorder such as chronic myeloid leukemia or myeloproliferative neoplasms, excluding myelodysplastic syndromes and chronic myelomonocytic leukemia
- •Candidate for allogeneic bone marrow or stem cell transplant at screening
- •Have achieved CR/CRi following therapy with hypomethylating agents
- •AML associated with inv(16), t(8;21), t(16;16), t(15;17), or t(9;22) karyotypes or molecular evidence of such translocations
- •Proven central nervous system leukemia
- •Prior bone marrow or stem cell transplantation
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Placebo Administration
Placebo Comparator
干预措施: Placebo (Other)
CC-486/Oral Azacitidine Administration
Experimental
干预措施: CC-486 (Drug)
结局指标
主要结局
Relapse-free survival (RFS)
时间窗: Up to 30 months
次要结局
- Number of participants with clinical laboratory abnormalities(Up to approximately 42 months)
- Healthcare Resource Utilization (HRU): Rate of Clinic Visits Per Year(Up to approximately 30 months)
- Time of maximum observed concentration (Tmax)(Up to 8 weeks)
- Minimal/measurable residual disease (MRD) assessment by flow cytometric analysis of hematopoietic cell immunophenotypes(Up to approximately 30 months)
- Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale(Up to approximately 30 months)
- Visual analog scale (VAS)(Up to approximately 30 months)
- Healthcare Resource Utilization (HRU): Rate of Hospital Events Per Year(Up to approximately 30 months)
- Healthcare Resource Utilization (HRU): Rate of Medical/Diagnostic Events Per Year(Up to approximately 30 months)
- Time to discontinuation of treatment(Up to approximately 42 months)
- Number of participants with physical examination abnormalities(Up to approximately 42 months)
- Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-t))(Up to 8 weeks)
- Terminal elimination half-life (T1/2)(Up to 8 weeks)
- Healthcare Resource Utilization (HRU): Number of Medications(Up to approximately 30 months)
- EQ-5D-5L scale(Up to approximately 30 months)
- Healthcare Resource Utilization (HRU): Number of Treatments for AEs Per Year(Up to approximately 30 months)
- Overall Survival (OS)(Up to approximately 42 months)
- Time to relapse(Up to approximately 30 months)
- Number of participants with adverse events (AEs)(Up to approximately 42 months)
- Number of participants with vital sign abnormalities(Up to approximately 42 months)
- Maximum observed plasma concentration (Cmax)(Up to 8 weeks)
研究者
研究点 (63)
Loading locations...
相似试验
进行中（未招募）
2 期
A Study to Compare the Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Best Supportive Care as Maintenance Therapy in Japanese Participants With Acute Myeloid Leukemia (AML) in Complete RemissionAcute Myeloid LeukemiaNCT05197426Bristol-Myers Squibb19
进行中（未招募）
1 期
Oral Azacitidine for the Treatment of Relapsed or Refractory T-cell Large Granular Lymphocytic LeukemiaT-Cell Large Granular Lymphocyte LeukemiaNCT05141682Jonathan Brammer11
进行中（未招募）
2 期
A Study to Compare the Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Participants With International Prognostic Scoring System Revised (IPSS-R) Low- or Intermediate-risk Myelodysplastic Syndrome (MDS)Myelodysplastic SyndromesNCT05469737Bristol-Myers Squibb230
已完成
2 期
Study of Vidaza (Azacitidine) Versus Support Treatment in Patients With Low Risk Myelodysplastic Syndrome (Low and Intermediate-1 IPSS) Without the 5q Deletion and Transfusion Dependent AnaemiaMyelodysplastic Syndrome (MDS)NCT01338337Asociación Andaluza de Hematología y Hemoterapia40
终止
2 期
Safety and Efficacy Study of CC-486 With MK-3475 to Treat Locally Advanced or Metastatic Non-small Cell Lung CancerCarcinoma, Non-Small-Cell LungNCT02546986Celgene100