Clinical trial NCT05413018: An Efficacy and Safety Study of Oral Azacitidine (CC-486) as Maintenance Therapy in Chinese Participants With Acute Myeloid Leukemia in Complete Remission
Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Compare Efficacy and Safety of Oral Azacitidine (CC-486) Plus Best Supportive Care Versus Best Supportive Care as Maintenance Therapy in Chinese Patients With Acute Myeloid Leukemia in Complete Remission
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Leukemia, Myeloid, Acute
Keywords: Azacitidine
CC-486
Onureg
Acute Myeloid Leukemia
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2022-06-09
Enrollment: 78
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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/exclusion criteria apply

Primary outcomes:
measure: Relapse-free survival (RFS)
timeFrame: Up to 30 months
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to approximately 42 months
measure: Time to relapse
timeFrame: Up to approximately 30 months
measure: Time to discontinuation of treatment
timeFrame: Up to approximately 42 months
measure: Number of participants with adverse events (AEs)
timeFrame: Up to approximately 42 months
measure: Number of participants with physical examination abnormalities
timeFrame: Up to approximately 42 months
measure: Number of participants with vital sign abnormalities
timeFrame: Up to approximately 42 months
measure: Number of participants with clinical laboratory abnormalities
timeFrame: Up to approximately 42 months
measure: Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-t))
timeFrame: Up to 8 weeks
measure: Maximum observed plasma concentration (Cmax)
timeFrame: Up to 8 weeks
measure: Time of maximum observed concentration (Tmax)
timeFrame: Up to 8 weeks
measure: Terminal elimination half-life (T1/2)
timeFrame: Up to 8 weeks
measure: Minimal/measurable residual disease (MRD) assessment by flow cytometric analysis of hematopoietic cell immunophenotypes
timeFrame: Up to approximately 30 months
measure: Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale
timeFrame: Up to approximately 30 months
measure: EQ-5D-5L scale
timeFrame: Up to approximately 30 months
measure: Visual analog scale (VAS)
timeFrame: Up to approximately 30 months
measure: Healthcare Resource Utilization (HRU): Rate of Hospital Events Per Year
timeFrame: Up to approximately 30 months
measure: Healthcare Resource Utilization (HRU): Number of Medications
timeFrame: Up to approximately 30 months
measure: Healthcare Resource Utilization (HRU): Rate of Clinic Visits Per Year
timeFrame: Up to approximately 30 months
measure: Healthcare Resource Utilization (HRU): Rate of Medical/Diagnostic Events Per Year
timeFrame: Up to approximately 30 months
measure: Healthcare Resource Utilization (HRU): Number of Treatments for AEs Per Year
timeFrame: Up to approximately 30 months
Other outcomes:
Locations:
city: Hefei
country: China
facility: Local Institution - 0031
state: Anhui
city: Beijing
country: China
facility: Local Institution - 0013
state: Beijing
city: Beijing
country: China
facility: Local Institution - 0027
state: Beijing
city: Chongqing
country: China
facility: Local Institution - 0028
state: CQ
city: Guangzhou
country: China
facility: Local Institution - 0003
state: Guangdong
city: Guangzhou
country: China
facility: Local Institution - 0008
state: Guangdong
city: Shenzhen
country: China
facility: Local Institution - 0010
state: Guangdong
city: Shijiazhuang
country: China
facility: Local Institution - 0002
state: Hebei
city: Xuzhou
country: China
facility: Local Institution - 0022
state: Jiangsu
city: Shenyang
country: China
facility: Local Institution - 0005
state: Liaoning
city: Shenyang
country: China
facility: Local Institution - 0020
state: Liaoning
city: Shanghai
country: China
facility: Local Institution - 0006
state: Shanghai
city: Taiyuan
country: China
facility: Local Institution - 0033
state: Shanxi
city: Chengdu
country: China
facility: Local Institution - 0016
state: Sichuan
city: Xian
country: China
facility: Local Institution - 0030
state: SN
city: Tianjin
country: China
facility: Local Institution - 0001
state: Tianjin
city: Urumqi
country: China
facility: Local Institution - 0009
state: Xinjiang
city: Wenzhou City
country: China
facility: Local Institution - 0007
state: Zhejiang
city: Changchun
country: China
facility: Local Institution - 0017
city: Changsha
country: China
facility: Local Institution - 0019
city: Changsha
country: China
facility: Local Institution - 0015
city: Ganzhou
country: China
facility: Local Institution - 0035
city: Guangzhou
country: China
facility: Local Institution - 0012
city: Hangzhou
country: China
facility: Local Institution - 0014
city: Harbin
country: China
facility: Local Institution - 0032
city: Jinan
country: China
facility: Local Institution - 0011
city: Kunming
country: China
facility: Local Institution - 0024
city: Lanzhou
country: China
facility: Local Institution - 0026
city: Nanchang
country: China
facility: Local Institution - 0018
city: Nanjing
country: China
facility: Local Institution - 0029
city: Soochow
country: China
facility: Local Institution - 0021
city: Tianjin
country: China
facility: Local Institution - 0023
city: Zhangzhou City
country: China
facility: Local Institution - 0034
city: Zhengzhou
country: China
facility: Local Institution - 0004
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: