Acute Myeloid leukemia in complete remission MedDRA version: 14.1 Level: PT Classification code 10000881 Term: Acute myeloid leukaemia (in remission) System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
CELGENE CORPORATION
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female subjects =55 years of age at the time of signing the ICD; 2. Newly diagnosed, histologically confirmed de novo AML or AML secondary to prior myelodysplastic disease; 3. Should have undergone induction therapy with intensive chemotherapy with or without consolidation therapy; 4. Should have achieved first CR/CRi status within 3 months prior to randomization; 5. ECOG performance status of 0, 1, 2 or 3; 6. Adequate bone marrow function based on ANCs = 0.5 x 109/L and platelet counts = 20,000 x 109/L; 7. Adequate organ function, defined as: • Serum bilirubin =1.5 times the upper limit of normal; • Serum aspartate aminotransferase and alanine aminotransferase =2.5 times the ULN; • Serum creatinine = 2.5 times the ULN; 8. FCBP may participate, providing they meet the following conditions: • Agree to practice abstinence; or • Agree to use at least two effective contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intrauterine device; barrier contraceptive with spermicide; or vasectomized partner) throughout the study, and for 3 months following the last dose of oral azacitidine; and • Have a negative serum pregnancy test (sensitivity of at least 25 mIU/mL) at screening; and • Have a negative serum or urine pregnancy test (Investigator's discretion) within 72 hours prior to starting study therapy in the doubleblind treatment phase (note that the screening serum pregnancy test can be used as the test prior to starting study therapy in the doubleblind treatment phase if it is performed within the 72 hour timeframe); 9. Male subjects with a female partner of childbearing potential must agree to practice abstinence or 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. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 115 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 345
Exclusion criteria
Exclusion criteria: 1. Suspected or proven acute promyelocytic leukemia (FAB M3) based on morphology, immunophenotype, molecular assay, or karyotype; or AML with previous hematologic disorder such as chronic myeloid leukemia or myeloproliferative neoplasms, excluding MDS; 2. 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; 3. Prior bone marrow or stem cell transplantation; 4. Have achieved CR/CRi following therapy with hypomethylating agents; 5. Received therapy with hypomethylating agents for MDS and went on to develop AML within four months of discontinuing the therapy with hypomethylating agents; 6. Proven central nervous system leukemia; 7. Candidate for allogeneic bone marrow or stem cell transplant at screening; 8. Diagnosis of malignant disease within the previous 12 months (excluding basal cell carcinoma of the skin without complications, ''insitu'' carcinoma of the cervix or breast, or other local malignancy excised or irradiated with a high probability of cure); 9. Unstable angina, significant cardiac arrhythmia, or New York Heart Association class 3 or 4 congestive heart failure 10. Uncontrolled systemic fungal, bacterial, or viral infection (defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics or other treatment); 11. Known active viral infection with known human immunodeficiency virus or viral hepatitis type B or C ;12. Known or suspected hypersensitivity to azacitidine or mannitol; 13. Use of any other experimental drug or therapy within 28 days prior to Day 1 of Cycle 1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to demonstrate if maintenance therapy with oral azacitidine improves OS compared with placebo in subjects with AML, age =55 years, who have achieved first CR or CRi after induction with intensive chemotherapy with or without consolidation chemotherapy;Secondary Objective: - To determine safety, tolerability; and - To determine the effect of oral azacitidine compared with placebo on HRQoL and healthcare resource utilization. Exploratory objectives: - To determine complete cytogenetic remission rate; - To evaluate molecular and/or cellular markers in the bone marrow post-induction and during maintenance therapy that may be predictive of clinical outcomes with therapy (placebo or oral azacitidine), including OS and RFS, following CR/CRi; and - To evaluate exploratory HRQoL measures.;Primary end point(s): Overall Survival;Timepoint(s) of evaluation of this end point: Estimated at 60 months after study initiation (approx. 330 deaths in total) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - RFS; -Time to relapse from CR/CRi; -Time to discontinuation from treatment; -Safety / tolerability (type, frequency, severity, and relationship of AEs to study treatments; physical examinations, vital signs; clinical laboratory evaluations, and concomitant medication/therapy); - Patient-reported outcomes utilizing the FACIT-Fatigue Scale and the EQ-5D; and - Measures of healthcare resource utilization;Timepoint(s) of evaluation of this end point: Estimated at 60 months after study initiation (approx. 330 deaths in total) | — |
Countries
Australia, Austria, Belgium, Czech Republic, Finland, France, Germany, Ireland, Israel, Italy, Korea, Republic of, Lithuania, Mexico, Poland, Portugal, Spain, United Kingdom
Contacts
Public ContactClinicalTrialDisclosure
Celgene Corporation
Outcome results
None listed