EUCTR2009-012346-23-BE进行中（未招募）1 期
A PHASE 3, MULTICENTER, RANDOMIZED,OPEN-LABEL, STUDY OF AZACITIDINE (VIDAZA®)VERSUS CONVENTIONAL CARE REGIMENS FOR THETREATMENT OF OLDER SUBJECTS WITH NEWLYDIAGNOSED ACUTE MYELOID LEUKEMIA
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
- 480
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
- •1. Diagnosis of one of the following:
- •- Newly diagnosed, histologically confirmed de novo AML or;
- •-AML secondary to prior myelodysplastic disease not treated with azacitidine, decitabine, or cytarabine or;
- •- AML secondary to exposure to potentially leukemogenic therapies or agents (eg, radiation therapy, alkylating agents, topoisomerase II inhibitors) with the primary malignancy in remission for at least 2 years;
- •2. Bone marrow blasts > 30%;
- •3. Male or female subjects = 65 years of age at the time of signing the informed consent document;
- •4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- •5. Adequate organ function, defined as:
- •-Serum bilirubin = 1.5 times the upper limit of normal (ULN);
- •-Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2.5 times the ULN;
- •- Serum creatinine = 1.5 times the ULN;
- •6. Females of childbearing potential must:
- •- Agree to the use of a physician-approved contraceptive method (oral, injectable, or
- •implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier
- •contraceptive with spermicide; or vasectomized partner) while on azacitidine; and for 3 months following the last dose of azacitidine; and
- •-Have a negative serum pregnancy test within 72 hours prior to starting study therapy.
- •7. Male subjects with a female partner of childbearing potential must agree to the use of a physician-approved contraceptive method throughout the course of the study and avoid fathering a child during the course of the study and for 3 months following the last dose of azacitidine;
- •8. Understand and voluntarily sign an informed consent document prior to any study related
- •assessments/procedures are conducted;
- •9. Able to adhere to the study visit schedule and other protocol requirements.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) no
- •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 480
排除标准
- •1. Previous cytotoxic (except hydroxyurea which is allowed up to 2 weeks prior to obtaining the hematology sample) or biologic treatment for AML
- •2. Previous treatment with azacitidine, decitabine, or cytarabine
- •3. Prior use of targeted therapy agents (eg, FLT3 inhibitors, other kinase inhibitors)
- •4. Suspected or proven acute promyelocytic leukemia (FAB M3) based on morphology, immunophenotype, molecular assay, or karyotype; or AML with prior hematologic disorder such as chronic myelogenous leukemia or myeloproliferative neoplasms;
- •5. AML associated with inv(16), t(8;21), t(16;16), t(15;17), or t(9;22) karyotypes or molecular evidence of such translocations
- •6. Prior bone marrow or stem cell transplantation
- •7. White blood cell (WBC) count > 15 x 10^9/L at screening;
- •a. Hydroxyurea is not allowed to attain a WBC count = 15 x 10^9/L;
- •8. Proven central nervous system leukemia
- •9. Inaspirable bone marrow
- •10. Candidate for allogeneic bone marrow or stem cell transplant
- •11. Diagnosis of malignant disease within the previous 12 months (excluding basal cell carcinoma of the skin without complications, in-situ” carcinoma of the cervix or breast, or other local malignancy excised or irradiated with a high probability of cure)
- •12. Malignant hepatic tumors
- •13. Unstable angina, significant cardiac arrhythmia, or New York Heart Association (NYHA)
- •class 3 or 4 congestive heart failure
- •14. Pregnant or lactating females
- •15. Uncontrolled systemic fungal, bacterial, or viral infection (defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics or other treatment)
- •16. Active viral infection with known human immunodeficiency virus (HIV) or viral hepatitis type B or C
- •17. Known or suspected hypersensitivity to azacitidine or mannitol
- •18. Use of any other experimental drug or therapy within 28 days prior to Day 1 of Cycle 1
- •19. Unwilling or unable to complete patient reported outcome assessments without assistance or with minimal assistance from trained site personnel and/or caregiver
- •20. Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study
- •21. Any significant medical condition, laboratory abnormality, or psychiatric illness that would interfere or prevent the subject from participating in the study
- •22. Any condition that confounds the ability to interpret data from the study.
研究者
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