Clinical trial NCT05197426: A Study to Compare the Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Best Supportive Care as Maintenance Therapy in Japanese Participants With Acute Myeloid Leukemia (AML) in Complete Remission
Official title: A Phase 2, Randomized, Double-Blind, Placebo-controlled Study to Compare Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Best Supportive Care as Maintenance Therapy in Japanese Subjects With Acute Myeloid Leukemia in Complete Remission
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Acute Myeloid Leukemia
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2022-01-19
Enrollment: 19
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 assess the efficacy and safety of oral azacitidine plus best supportive care versus best supportive care as maintenance therapy in a cohort of Japanese participants ≥ 55 years of age with Acute Myeloid Leukemia (AML) and in complete remission/complete remission with incomplete blood count recovery after conventional induction chemotherapy with or without consolidation chemotherapy.


Eligibility criteria: Inclusion Criteria:

* ≥ 55 years of age inclusive at the time of signing the informed consent
* Newly diagnosed, histologically confirmed de novo Acute Myeloid Leukemia (AML) or AML secondary to prior myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML)
* Should have undergone induction therapy with intensive chemotherapy with or without consolidation therapy as recommended in appropriate guideline(s) or equivalent regimen according to institutional standard: having achieved first complete remission (CR)/complete remission with incomplete blood count recovery (CRi) status within 4 months prior to starting study therapy

Exclusion Criteria:

* Suspected or proven acute promyelocytic leukemia; or AML with previous hematologic disorder such as chronic myeloid leukemia or myeloproliferative neoplasms, excluding MDS and CMML
* Prior bone marrow or stem cell transplantation
* Received therapy with hypomethylating agents for MDS and went on to develop AML within four months of discontinuing the therapy with hypomethylating agents
* Have achieved CR/CRi following therapy with hypomethylating agents

Other protocol-defined inclusion/exclusion criteria apply

Primary outcomes:
measure: Relapse-free Survival (RFS)
timeFrame: Up to 27 months
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to 27 months
measure: Time to relapse from Complete Remission (CR)
timeFrame: Up to 27 months
measure: Time to relapse from complete remission with incomplete blood count recovery (CRi)
timeFrame: Up to 27 months
measure: Time to discontinuation from treatment
timeFrame: Up to 27 months
measure: Number of participants with Adverse Events
timeFrame: Up to 50 months
measure: Number of participants with physical examination abnormalities
timeFrame: Up to 50 months
measure: Number of participants with vital sign abnormalities
timeFrame: Up to 50 months
measure: Number of participants with clinical laboratory abnormalities
timeFrame: Up to 50 months
measure: Maximum observed plasma concentration (Cmax)
timeFrame: Up to 27 months
measure: Time of maximum observed plasma concentration (Tmax)
timeFrame: Up to 27 months
measure: Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T))
timeFrame: Up to 27 months
measure: Area under the serum concentration-time curve from time 0 to infinity AUC(INF)
timeFrame: Up to 27 months
measure: Number of participant-reported outcomes utilizing the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Scale
timeFrame: Up to 27 months
measure: Number of participant-reported outcomes utilizing the EuroQol 5-dimension 5-level questionnaire (EQ-5D-5L)
timeFrame: Up to 27 months
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Local Institution - 0011
state: Alabama
city: Nagoya
country: Japan
facility: Local Institution - 0017
state: Aichi
city: Nagoya
country: Japan
facility: Local Institution - 0023
state: Aichi
city: Toyoake
country: Japan
facility: Local Institution - 0009
state: Aichi
city: Aomori-shi
country: Japan
facility: Local Institution - 0022
state: Aomori
city: Kamogawa
country: Japan
facility: Local Institution - 0005
state: Chiba
city: Kashiwa-shi
country: Japan
facility: Local Institution - 0003
state: Chiba
city: Matsuyama
country: Japan
facility: Local Institution - 0010
state: Ehime
city: Yoshida gun
country: Japan
facility: Local Institution - 0020
state: Fukui
city: Fukuoka-shi
country: Japan
facility: Local Institution - 0016
state: Fukuoka
city: Ogaki
country: Japan
facility: Local Institution - 0014
state: Gifu
city: Maebashi
country: Japan
facility: Local Institution - 0001
state: Gunma
city: Sapporo
country: Japan
facility: Local Institution - 0004
state: Hokkaido
city: Kanazawa
country: Japan
facility: Local Institution - 0019
state: Ishikawa
city: Isehara
country: Japan
facility: Local Institution - 0012
state: Kanagawa
city: Sagamihara-shi
country: Japan
facility: Local Institution - 0006
state: Kanagawa
city: Yokohama
country: Japan
facility: Local Institution - 0013
state: Kanagawa
city: Sendai
country: Japan
facility: Local Institution - 0015
state: Miyagi
city: Osaka Sayama
country: Japan
facility: Local Institution - 0021
state: Osaka
city: Osaka shi
country: Japan
facility: Local Institution - 0026
state: Osaka
city: Shimotsuke
country: Japan
facility: Local Institution - 0031
state: Tochigi
city: Bunkyo Ku
country: Japan
facility: Local Institution - 0032
state: Tokyo
city: Shinagawa
country: Japan
facility: Local Institution - 0002
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Local Institution - 0030
state: Tokyo
city: Sumida ku
country: Japan
facility: Local Institution - 0029
state: Tokyo
city: Fukuoka
country: Japan
facility: Local Institution - 0018
city: Fukuoka
country: Japan
facility: Local Institution - 0027
city: Nagasaki
country: Japan
facility: Local Institution - 0008
city: Okayama
country: Japan
facility: Local Institution - 0025
city: Saitama
country: Japan
facility: Local Institution - 0028
city: Yamagata
country: Japan
facility: Local Institution - 0007
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: