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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05197426
Other study ID # CA055-005
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date January 17, 2022
Est. completion date April 30, 2026

Study information

Verified date October 2023
Source Bristol-Myers Squibb
Contact BMS Study Connect Contact Center www.BMSStudyConnect.com
Phone 855-907-3286
Email Clinical.Trials@bms.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 15
Est. completion date April 30, 2026
Est. primary completion date January 27, 2025
Accepts healthy volunteers No
Gender All
Age group 55 Years and older
Eligibility 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

Study Design


Intervention

Drug:
Oral Azacitidine
Specified dose on specified days
Other:
Placebo
Specified dose of specified days

Locations

Country Name City State
Japan Local Institution - 0022 Aomori
Japan Local Institution - 0032 Bunkyo Ku Tokyo
Japan Local Institution - 0018 Fukuoka
Japan Local Institution - 0027 Fukuoka
Japan Local Institution - 0016 Fukuoka-shi Fukuoka
Japan Local Institution - 0012 Isehara Kanagawa
Japan Local Institution - 0005 Kamogawa Chiba
Japan Local Institution - 0019 Kanazawa Ishikawa
Japan Local Institution - 0003 Kashiwa-shi Chiba
Japan Local Institution - 0001 Maebashi Gunma
Japan Local Institution - 0010 Matsuyama Ehime
Japan Local Institution - 0008 Nagasaki
Japan Local Institution - 0017 Nagoya Aichi
Japan Local Institution - 0023 Nagoya-shi
Japan Local Institution - 0014 Ogaki Gifu
Japan Local Institution - 0025 Okayama
Japan Local Institution - 0026 Osaka
Japan Local Institution - 0021 Osaka Sayama Osaka
Japan Local Institution - 0006 Sagamihara Kanagawa
Japan Local Institution - 0028 Saitama shi Saitama
Japan Local Institution - 0004 Sapporo Hokkaido
Japan Local Institution - 0015 Sendai-shi Miyagi
Japan Local Institution - 0031 Shimotsuke Tochigi
Japan Local Institution - 0002 Shinagawa ku Tokyo
Japan Local Institution - 0030 Shinjyuku Ku Tokyo
Japan Local Institution - 0029 Sumida ku Tokyo
Japan Local Institution - 0009 Toyoake Aichi
Japan Local Institution - 0007 Yamagata
Japan Local Institution - 0013 Yokohama Kanagawa
Japan Local Institution - 0020 Yoshida gun Fukui
United States Local Institution - 0011 Huntsville Alabama

Sponsors (1)

Lead Sponsor Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Relapse-free Survival (RFS) Up to 27 months
Secondary Overall Survival (OS) Up to 27 months
Secondary Time to relapse from Complete Remission (CR) Up to 27 months
Secondary Time to relapse from complete remission with incomplete blood count recovery (CRi) Up to 27 months
Secondary Time to discontinuation from treatment Up to 27 months
Secondary Number of participants with Adverse Events Up to 50 months
Secondary Number of participants with physical examination abnormalities Up to 50 months
Secondary Number of participants with vital sign abnormalities Up to 50 months
Secondary Number of participants with clinical laboratory abnormalities Up to 50 months
Secondary Maximum observed plasma concentration (Cmax) Up to 27 months
Secondary Time of maximum observed plasma concentration (Tmax) Up to 27 months
Secondary Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T)) Up to 27 months
Secondary Area under the serum concentration-time curve from time 0 to infinity AUC(INF) Up to 27 months
Secondary Number of participant-reported outcomes utilizing the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Scale Up to 27 months
Secondary Number of participant-reported outcomes utilizing the EuroQol 5-dimension 5-level questionnaire (EQ-5D-5L) Up to 27 months
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