A Phase 2, Multicenter, Randomized, Open-label, Parallel-group Study of a Lenalidomide (Revlimid®) Regimen or a Sequential Azacitidine (Vidaza®) Plus Lenalidomide (Revlimid®) Regimen Versus an Azacitidine (Vidaza®) Regimen for Therapy of Older Subjects With Newly Diagnosed Acute Myeloid Leukemia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Celgene
- 入组人数
- 88
- 试验地点
- 30
- 主要终点
- Overall Survival
研究概览
简要总结
The study aim is to compare safety and efficacy of high-dose lenalidomide regimen, sequential azacitidine and lenalidomide and an azacitidine in persons ≥65 years with newly-diagnosed acute myeloid leukemia (AML).
详细描述
On September 11, 2013, randomization into the continuous 50 mg lenalidomide only arm was temporarily suspended based on review of the data from the first 13 participants and a high rate of discontinuation (11/13 participants). The Data Monitoring Committee assessed the study data on September 20, 2013 and reported no safety concerns. The high rate of early discontinuation is inconsistent with the treatment duration required for testing the study primary endpoint of survival at one year. Consequently, Celgene has decided not to reopen the lenalidomide only arm.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed acute myeloid leukemia (AML), AML with antecedent hematologic disorder or therapy-related AML
- •Male or female subjects aged ≥ 65
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
- •White blood cell (WBC) count ≤ 10 x 10⁹/L at screening
排除标准
- •Previous treatment with azacitidine, decitabine, cytarabine or lenalidomide
- •Previous cytotoxic or biologic treatment of any kind for AML or prior use of targeted therapy agents.
- •Suspected or proven acute promyelocytic leukemia
- •Prior bone marrow or stem cell transplantation
- •Candidate for allogeneic bone marrow or stem cell transplantation
- •AML antecedent hematologic disorder such as chronic myelogenous leukemia or myeloproliferative neoplasms
- •Presence of malignant disease within the previous 12 months with exceptions
研究组 & 干预措施
Lenalidomide in combination with azacitidine
Repeated cycles of azacitidine 75 mg/m^2/day subcutaneous (SC) on Days 1-7 and lenalidomide 50 mg/day by mouth (PO) on Days 8-28 followed by a 14-day break plus best supportive care
干预措施: Azacitidine (Drug)
Lenalidomide in combination with azacitidine
Repeated cycles of azacitidine 75 mg/m^2/day subcutaneous (SC) on Days 1-7 and lenalidomide 50 mg/day by mouth (PO) on Days 8-28 followed by a 14-day break plus best supportive care
干预措施: Lenalidomide (Drug)
Lenalidomide in combination with azacitidine
Repeated cycles of azacitidine 75 mg/m^2/day subcutaneous (SC) on Days 1-7 and lenalidomide 50 mg/day by mouth (PO) on Days 8-28 followed by a 14-day break plus best supportive care
干预措施: Best Supportive Care (BSC) (Other)
Lenalidomide - single agent
Lenalidomide 50 mg PO daily for 28 days for the first 2 cycles and lenalidomide 25 mg daily for 28 days for the next 2 cycles followed by continuous 28-day cycles of lenalidomide 10 mg daily PO plus best supportive care
干预措施: Lenalidomide (Drug)
Lenalidomide - single agent
Lenalidomide 50 mg PO daily for 28 days for the first 2 cycles and lenalidomide 25 mg daily for 28 days for the next 2 cycles followed by continuous 28-day cycles of lenalidomide 10 mg daily PO plus best supportive care
干预措施: Best Supportive Care (BSC) (Other)
Azacitidine-single agent
Repeated cycles of azacitidine 75mg/m^2/day subcutaneous on Days 1-7 followed by a 21-day break plus best supportive care
干预措施: Azacitidine (Drug)
Azacitidine-single agent
Repeated cycles of azacitidine 75mg/m^2/day subcutaneous on Days 1-7 followed by a 21-day break plus best supportive care
干预措施: Best Supportive Care (BSC) (Other)
结局指标
主要结局
Overall Survival
时间窗: From date of randomization until the date of the first documented date of progression or date of death of any cause; the overall median follow-up for survivng participants was 4.1 months (range 0.2 to 54.8 months)
Overall Survival reported at the end of the study are for those participants who were alive at the end of the study
Kaplan Meier Estimates for One Year Survival
时间窗: Up to 24 months
One-year survival rate was defined as all deaths within one year from the date of randomization. All others censored at the at year 1 or date of discontinuation
次要结局
- Cytogenetic Complete Remission Rate (CRc)(Cytogenetic Complete Remission timeframe was not analyzed.)
- Event-Free Survival (EFS)(Event-Free survival time was not analyzed.)
- Relapse-Free Survival (RFS)(Relapse-Free survival time frame was not analyzed.)
- Number of Participants With a Second Primary Malignancy(From randomization of the last participant up to a minimum of 4 years following discontinuation)
- Percentage of Participants With a Complete Response or Morphologic Incomplete Response.(Complete Response or Morphologic Incomplete Response data not analyzed.)
- Percentage of Participants With 30-Day Treatment-Related Mortality(30 days)
- Number of Participants With Treatment Emergent Adverse Events (TEAE)(From the first dose of study drug up to 28 days after the last dose of study drug; up to 15 May 2018)
- Duration of Remission (DoR)(Duration of Remission (DoR) time frame not analyzed.)
- Percentage of Participants With an Overall Response Rate (CR +CRi+ PR)(Overall response rate time frame was not analyzed.)
- Progression-Free Survival (PFS)(Progression-Free survival data and time frame was not analyzed.)