EUCTR2014-003065-15-NO进行中（未招募）1 期
A MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PHASE III STUDY OF IDASANUTLIN, AN MDM2 ANTAGONIST, WITH CYTARABINE VERSUS CYTARABINE PLUS PLACEBO IN PATIENTS WITH RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA (AML).
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 440
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Age >=18 years
- •- Documented/confirmed 1st/2nd refractory/relapsed AML using World Health Organization classification, except acute promyelocytic leukemia
- •- No more than 2 prior induction regimens (excl. prior HSCT) and one must have included cytarabine with an anthracycline (or anthracenedione)
- •- Eastern Cooperative Oncology Group performance status of 0 to 1
- •- Patient should be a potential candidate for allogeneic HSCT
- •- Adequate hepatic and renal function.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 176
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 264
排除标准
- •- Patients with CR1 duration of >1 year AND age <60 years
- •- Patients with AML with myelodysplasia related changes, or AML that has developed as a consequence of an AHD
- •- AML secondary to any prior chemotherapy unrelated to leukemia
- •- Patients who have received more than two prior cytarabine containing induction regimens for AML
- •- Patients who have relapsed within 90 days after therapy with intermediate-dose cytosine arabinoside (IDAC) or high-dose cytosine arabinoside (HiDAC) containing regimens
- •- Patients who have received allogeneic HSCT within 90 days prior to randomization
- •- Patients who have received immunosuppressive therapy for graft versus host disease (G versus HD) within 2 weeks prior to study start
- •- Prior treatment with a Murine Double Minute 2 (MDM2) antagonist
- •- Patients receiving any other investigational or commercial agents or therapies administered with the intention to treat their malignancy
- •- Patients with a history of other malignancy within 5 years prior to screening
- •- Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
- •- Pregnant or breastfeeding patients.
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