Leukemia, Myeloid, Acute
Conditions
Keywords
Azacitidine, CC-486, Onureg, Acute Myeloid Leukemia
Brief summary
The purpose of this study is to evaluate the efficacy and safety of Oral Azacitidine (CC-486) in Chinese participants with acute myeloid leukemia in complete remission.
Interventions
DRUGCC-486
Specified dose on specified days
OTHERPlacebo
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Newly diagnosed, histologically confirmed de novo acute myeloid leukemia (AML) or AML secondary to prior myelodysplastic disease or chronic myelomonocytic leukemia (CMML) * Eastern cooperative oncology group performance status of 0, 1, or 2 * Has undergone induction therapy with intensive chemotherapy with or without consolidation therapy * Must have achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) status within 6 months (+/- 7 days) prior to starting study therapy
Exclusion criteria
* Suspected or proven acute promyelocytic leukemia or acute myeloid leukemia with previous hematologic disorder such as chronic myeloid leukemia or myeloproliferative neoplasms, excluding myelodysplastic syndromes and chronic myelomonocytic leukemia * Candidate for allogeneic bone marrow or stem cell transplant at screening * Have achieved CR/CRi following therapy with hypomethylating agents * 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 * Proven central nervous system leukemia * Prior bone marrow or stem cell transplantation Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relapse-free survival (RFS) | Up to 30 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | Up to approximately 42 months | — |
| Time to relapse | Up to approximately 30 months | — |
| Time to discontinuation of treatment | Up to approximately 42 months | — |
| Number of participants with adverse events (AEs) | Up to approximately 42 months | — |
| Number of participants with physical examination abnormalities | Up to approximately 42 months | — |
| Number of participants with vital sign abnormalities | Up to approximately 42 months | — |
| Number of participants with clinical laboratory abnormalities | Up to approximately 42 months | — |
| Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-t)) | Up to 8 weeks | — |
| Maximum observed plasma concentration (Cmax) | Up to 8 weeks | — |
| Time of maximum observed concentration (Tmax) | Up to 8 weeks | — |
| Terminal elimination half-life (T1/2) | Up to 8 weeks | — |
| Minimal/measurable residual disease (MRD) assessment by flow cytometric analysis of hematopoietic cell immunophenotypes | Up to approximately 30 months | — |
| Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale | Up to approximately 30 months | — |
| EQ-5D-5L scale | Up to approximately 30 months | — |
| Visual analog scale (VAS) | Up to approximately 30 months | — |
| Healthcare Resource Utilization (HRU): Rate of Hospital Events Per Year | Up to approximately 30 months | HRU is defined as any consumption of healthcare resources directly or indirectly related to the treatment of the participant. HRU is a key component to understand treatment costs and budget impact of new treatments from a provider perspective. |
| Healthcare Resource Utilization (HRU): Number of Medications | Up to approximately 30 months | HRU is defined as any consumption of healthcare resources directly or indirectly related to the treatment of the participant. HRU is a key component to understand treatment costs and budget impact of new treatments from a provider perspective. |
| Healthcare Resource Utilization (HRU): Rate of Clinic Visits Per Year | Up to approximately 30 months | HRU is defined as any consumption of healthcare resources directly or indirectly related to the treatment of the participant. HRU is a key component to understand treatment costs and budget impact of new treatments from a provider perspective. |
| Healthcare Resource Utilization (HRU): Rate of Medical/Diagnostic Events Per Year | Up to approximately 30 months | HRU is defined as any consumption of healthcare resources directly or indirectly related to the treatment of the participant. HRU is a key component to understand treatment costs and budget impact of new treatments from a provider perspective. |
| Healthcare Resource Utilization (HRU): Number of Treatments for AEs Per Year | Up to approximately 30 months | HRU is defined as any consumption of healthcare resources directly or indirectly related to the treatment of the participant. HRU is a key component to understand treatment costs and budget impact of new treatments from a provider perspective. |
Countries
China
Contacts
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed