EUCTR2014-003065-15-ES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).
Roche Farma, S.A., que representa en España a F. Hoffmann-La Roche Ltd.0 个研究点目标入组 440 人开始时间: 2016年1月11日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 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.
研究者
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