A PHASE 3, MULTICENTER, RANDOMIZED, OPEN-LABEL, STUDY OF AZACITIDINE (VIDAZA) VERSUS CONVENTIONAL CARE REGIMENS FOR THE TREATMENT OF OLDER SUBJECTS WITH NEWLY DIAGNOSED ACUTE MYELOID LEUKEMIA - ND
- Conditions
- ewly diagnosed de novo Acute Myeloid Leukemia (AML) or AML secondary to prior myelodysplastic disease in older subjects with >30% bone marrow blasts and who are not eligible for hematopoietic stem cell transplantationMedDRA version: 9.1Level: LLTClassification code 10000886
- Registration Number
- EUCTR2009-012346-23-IT
- Lead Sponsor
- Celgene Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 480
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:
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
1. Previous cytotoxic (except hydroxyurea) 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; 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 109/L at screening; 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 (see Appendix D); 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method