EUCTR2009-013669-25-DE进行中（未招募）不适用
An Open-Label Randomized Phase 2 Study of the X-Linked Inhibitor of Apoptosis (XIAP) Antisense AEG35156 Given in Combination with High-dose Cytarabine and Idarubicin in AML Following Failure of a Single Standard Dose Cytarabine Based Frontline Induction Regimen.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
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
- •- Patients with AML, except those with APL (acute promyelocytic leukemia), failing a
- •single standard dose cytarabine based frontline induction regimen. The diagnosis of
- •refractory AML is based on the presence of either > 10% blasts in marrow or blood
- •or 5-10% blasts in either site together with cytopenia (Hb < 10 g/dL, or platelets <
- •100 x 10^9/L, or neutrophil count < 1.0 x 10^9/L).
- •- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance
- •status of =2.
- •- Patients must be =18 years old.
- •- Male, or female patients who are post-menopausal (amenorrhagic for at least 12
- •months), or surgically or biologically sterile. Females of childbearing potential
- •must have a negative serum pregnancy test within 72 hours prior to the 1st
- •infusion in the study and using adequate forms of contraception for the duration of
- •the study, including 30 days after the last treatment. Males should avoid fathering
- •children during the course of the study. Patients and their partners with
- •reproductive potential must use an effective contraceptive method while the
- •patient is on the study treatment and for 30 days after the last treatment.
- •Adequate methods of contraception are double barrier methods (condoms with
- •spermicidal jelly or foam, and diaphragm with spermicidal jelly or foam), oral, depot
- •and injectable contraceptives, IUD, and surgical sterilization. Single barrier
- •methods, rhythm methods, abstinence or sterility of a partner will not be
- •considered adequate contraception.
- •- Patients must have adequate organ and immune function as indicated by the
- •following laboratory values:
- •Parameter Laboratory Values
- •Serum creatinine; =2.0 mg/dL (=177 µmol/L)
- •Total Bilirubin =2.0 mg/dL (=34 µmol/L)
- •AST (SGOT) and ALT (SGPT) =3 X ULN *
- •*ULN: Institution’s upper limit of normal.
- •- The patient must understand, be able and willing and likely to fully comply with
- •study procedures, including scheduled follow-up, and restrictions.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Clinical evidence of ongoing grade 3 or 4 non-hematological toxicities from the
- •initial standard dose cytarabine-based induction chemotherapy.
- •- Patients with a prior history of peripheral neuropathy of grade 2 or higher.
- •- Clinical evidence of active CNS leukemic involvement.
- •- Active and uncontrolled infection. Patients with an infection who are under active
- •treatment with antibiotics and whose infections are controlled may be entered to
- •- Current evidence of invasive fungal infection (blood or tissue culture).
- •- Current evidence of an active second malignancy except for non-melanoma skin
- •- Uncontrolled medical problems, unrelated to the malignancy, or of sufficient severity
- •that in the opinion of the investigator, impair a patient’s ability to give informed
- •consent or unacceptably reduce the safety of the proposed treatment.
- •- Neurological or psychiatric disorders that would interfere with consent or study
- •follow-up.
- •- Known or suspected intolerance or hypersensitivity to the study drugs [or closely
- •related compounds] or any of their stated ingredients. Study drugs being the
- •antisense, cytarabine and idarubicin.
- •- History of alcohol or other substance abuse within the last year.
- •- Use of another investigational agent within the last 14 days prior to enrolment.
- •Patients who have received a previous antisense agent in the last 90 days will be
- •- Female patients who are pregnant, lactating, or with a positive pregnancy test at
- •screening must be excluded.
- •- Patients who have previously been enrolled into this study and subsequently
- •withdrawn must also be excluded.
- •Both men and women and members of all races and ethnic groups are eligible for
- •this trial.
研究者
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