EUCTR2014-003065-15-AT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).
适应症
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
入选标准
- •- Age >=18 years
- •- Documented/confirmed first or second refractory or relapsed AML using World Health Organization classification, except acute
- •promyelocytic leukemia and first relapsed AML patients with a CR1 duration of >1 year AND age < 60 years
- •- No more than 2 prior induction regimens (excluding prior HSCT) in their first line treatment and one must have included cytarabine with an anthracycline (or anthracenedione)
- •- Eastern Cooperative Oncology Group performance status of 0 to 2
- •- Adequate hepatic and renal function
- •- WBC count at randomization of <=50,000/ cubic millimeter (mm3).
- •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
- •- First relapsed patients aged < 60 years with a CR1 duration of > 1 year
- •- Patients with prior documented antecedent hematological disorder
- •- AML secondary to any prior chemotherapy unrelated to leukemia
- •- Patients who are either refractory to/or relapsed within 90 days of
- •receiving a regimen containing a cumulative dose of >=18 gram/square meter cytarabine
- •- Patients who have received allogeneic HSCT within 90 days prior to
- •randomization
- •- Patients who have received immunosuppressive therapy for graftversus-host disease or for engraftment syndrome after autologous stem cell transplantation within 2 weeks prior to randomization
- •- Prior treatment with a Murine Double Minute 2 (MDM2) antagonist
- •- Patients with clinically relevant QTc prolongation (QTcF > 480 ms), a
- •family history of long QT syndrome, or who are currently receiving
- •treatment with medications that are known to prolong the QT interval
- •- Patients receiving any other investigational or commercial agents or
- •therapies administered with the intention to treat their malignancy
- •within 30 days from the first receipt of study drug with the exception of
- •HU or leukapheresis in patients who need to continue this therapy to
- •maintain a WBC count <=50000/mm3. HU or leukapheresis must be
- •discontinued at least 24 hours prior to the initiation of study medication
- •- Patients with acute toxicities from any prior anti-leukemia therapy
- •that have not resolved to Grade <=2 per National Cancer Institute (NCI)
- •Common Terminology for Adverse Events (CTCAE), Version 4.03
- •- Patients with a history of other malignancy within 5 years prior to
- •screening except for malignancy that has been in remission without
- •treatment for at least 2 years prior to randomization
- •- Patients unable to temporarily interrupt treatment with moderate to
- •strong CYP2C8 inducers and inhibitors (including gemfibrozil, which is
- •also an inhibitor of UGT1A3), CYP2C8 or OATP1B1/3 substrates, or
- •strong CYP3A4 inducers during the treatment phase. These agents must be discontinued 7-14 days prior to the start of study medication
- •- Patients unable to temporarily interrupt treatment with oral or
- •parenteral anticoagulants/anti-platelet agents (e.g., warfarin, chronic
- •daily treatment with aspirin [> 325 mg/day], clopidogrel, dabigatran,
- •apixaban, rivaroxaban, or subcutaneous [SC] anticoagulant prophylaxis) during the treatment phase. These agents must be discontinued 7 days (or 5 half-lives) prior to the start of study medication
- •Note: Treatment with or switch to low molecular weight heparin (LMWH) or unfractionated heparin (UFH) is allowed, according to local practice. However, platelet levels need to be closely monitored in these patients
- •- Patients with a history of systemic hypersensitivity reactions >=Grade
- •2 attributed to cytarabine
- •- Patients who have any severe and/or uncontrolled medical conditions
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