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临床试验/NL-OMON47508
NL-OMON47508已完成3 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). - WO29519, MIRROS

Roche Nederland B.V.0 个研究点目标入组 10 人开始时间: 待定最近更新:
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适应症

试验速览

阶段
3 期
状态
已完成
入组人数
10
研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 99（—）

入选标准

  • •- Age * 18 years,
  • •- Documented/confirmed 1st/2nd refractory/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 (excl. 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 * 2
  • •- Adequate hepatic function assessed by the following: Serum total bilirubin *
  • •1.5 x institutional upper limit of normal (ULN), unless resulting from
  • •hemolysis, Gilbert*s syndrome, or liver infiltration with leukemia. AST/ALT * 3
  • •x institutional ULN (or * 5 x upper limit of institutional laboratory reference
  • •range if liver infiltration with leukemia)
  • •- Adequate renal function assessed by serum creatinine within reference
  • •laboratory ranges OR creatinine clearance (by Cockcroft Gault formula) * 50
  • •- WBC count at randomization of *50.000/mm3
  • •Note: When treatment is not started immediately upon randomization, the WBC
  • •count at the start of induction therapy (C1) must remain at *50.000/mm3. The
  • •use of hydroxyurea (HU) or leukapheresis to meet eligibility is allowed. HU or
  • •leukapheresis must be discontinued at least 24 hours prior to the initiation of
  • •study medication.
  • •- For women of childbearing potential: agreement to remain abstinent (refrain
  • •from heterosexual intercourse) or use two adequate methods of contraception,
  • •including at least one method with a failure rate of < 1% per year, during the
  • •treatment period and for up to 6 months after the last dose of study drug.
  • •Examples of contraceptive methods with a failure rate of < 1% per year include
  • •bilateral tubal ligation, male sterilization, and established, proper use of
  • •hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine
  • •devices, and copper intrauterine devices.
  • •The reliability of sexual abstinence should be evaluated in relation to the
  • •duration of the clinical trial and the preferred and usual lifestyle of the
  • •patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or
  • •postovulation methods) and withdrawal are not acceptable methods of
  • •contraception. Barrier methods must always be supplemented with the use of a
  • •spermicide., - For men unless permanently sterile by bilateral orchidectomy:
  • •agreement to remain abstinent (refrain from heterosexual intercourse) or use
  • •contraceptive measures and agreement to refrain from donating sperm, as defined
  • •With female partners of childbearing potential or pregnant female partners, men
  • •must remain abstinent or use a condom during the treatment period and for up to
  • •6 months after the last dose of study drug. Men must refrain from donating
  • •sperm during this same period.
  • •The reliability of sexual abstinence should be evaluated in relation to the
  • •duration of the clinical trial and the preferred and usual lifestyle of the
  • •patient., - Ability to understand and willingness to sign a written informed
  • •consent form and comply with all study requirements including completion of PRO

排除标准

  • •- First relapsed patients with CR1 duration of >1 year AND age <60 years,
  • •- Patients with prior documented AHD including the following: myelodysplastic
  • •syndrome, myeloproliferative disease (i.e., chronic myelomonocytic leukemia,
  • •polycythemia vera, primary myelofibrosis, and essential thrombocythemia), and
  • •aplastic anemia,
  • •- AML secondary to any prior chemotherapy unrelated to leukemia,
  • •- Patients who are either refractory to or have relapsed within 90 days of
  • •receiving a regimen containing a cumulative dose of * 18 g/m2 cytarabine,
  • •- Patients who have received allogeneic HSCT within 90 days prior to
  • •randomization. HSCT should have been performed in remission and not used for
  • •salvage (patients who have received autologous HSCT as consolidation in CR1 are
  • •eligible).,
  • •- Patients who have received immunosuppressive therapy for graft versus host
  • •disease (GvHD) 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 (or 5 half-lives) from first receipt of study drug. Note: The exception is
  • •HU or leukapheresis in patients who need to continue this therapy to maintain a
  • •WBC count * 50,000/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 which
  • •have not resolved to Grade * 2 per National Cancer Institute Common Terminology
  • •Criteria for Adverse Events (NCI 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
  • •as defined inTable 3, Table 4, and Table 5 of the protocol 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)
  • •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 (see protocol).
  • •- Patients with history of systemic hypersensitivity reactions * grade 2
  • •attributed to cytarabine or components of the formulated product,
  • •- Patients who have any severe and/or uncontrolled medical conditions or other

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