EUCTR2009-012346-23-DE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,
- •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;
- •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
- •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
研究者
相似试验
进行中（未招募）
1 期
Study of Vidaza Versus Conventional Care Regimens for the Treatment of Acute Myeloid Leukemia (AML)EUCTR2009-012346-23-NLCelgene Corporation480
进行中（未招募）
1 期
Study of Vidaza Versus Conventional Care Regimens for the Treatment of Acute Myeloid Leukemia (AML)EUCTR2009-012346-23-ATCelgene Corporation480
进行中（未招募）
不适用
Study of Vidaza Versus Conventional Care Regimens for the Treatment of Acute Myeloid Leukemia (AML)EUCTR2009-012346-23-CZCelgene Corporation480
进行中（未招募）
1 期
Study of Vidaza Versus Conventional Care Regimens for the Treatment of Acute Myeloid Leukemia (AML)ewly diagnosed de novo Acute Myeloid Leukemia (AML) or AML secondary to prior myelodysplasticdisease in older subjects with >30% bone marrow blasts and who are not eligible for hematopoietic stem cell transplantation.MedDRA version: 18.0Level: LLTClassification code 10000886Term: Acute myeloid leukemiaSystem Organ Class: 100000004864EUCTR2009-012346-23-BECelgene Corporation480
进行中（未招募）
1 期
A PHASE 3, MULTICENTER, RANDOMIZED, OPEN-LABEL STUDY TO COMPARE THE EFFICACY AND SAFETY OF POMALIDOMIDE, BORTEZOMIB AND LOW-DOSE DEXAMETHASONE VERSUS BORTEZOMIB AND LOW-DOSE DEXAMETHASONE IN SUBJECTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMAEUCTR2014-000268-17-SECelgene Corporation559