Study of Vidaza Versus Conventional Care Regimens for the Treatment of Acute Myeloid Leukemia (AML)

Phase 1

• Conditions: 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: 100000004864; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2009-012346-23-BE
• Lead Sponsor: Celgene Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-03
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 480

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified