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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

  • Clinicaltrials.gov identifier

    NCT05197426

  • Recruitment Status

    Recruiting

  • First Posted

    January 19, 2022

  • Last update posted

    May 27, 2022

Study Description

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.

  • Condition or Disease:Acute Myeloid Leukemia
  • Intervention/Treatment: Drug: Oral Azacitidine
    Other: Placebo
  • Phase: Phase 2

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 66 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment
  • Official Title: 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
  • Actual Study Start Date: January 2022
  • Estimated Primary Completion Date: June 2024
  • Estimated Study Completion Date: April 2026

Arms and interventions

Arm Intervention/treatment
Experimental: Oral Azacitidine
Drug: Oral Azacitidine
Specified dose on specified days
Placebo Comparator: Placebo
Other: Placebo
Specified dose of specified days

Outcome Measures

  • Primary Outcome Measures: 1. Relapse-free Survival (RFS) [ Time Frame: Up to 27 months ]
  • Secondary Outcome Measures: 1. Overall Survival (OS) [ Time Frame: Up to 27 months ]
  • 2. Time to relapse from Complete Remission (CR) [ Time Frame: Up to 27 months ]
  • 3. Time to relapse from complete remission with incomplete blood count recovery (CRi) [ Time Frame: Up to 27 months ]
  • 4. Time to discontinuation from treatment [ Time Frame: Up to 27 months ]
  • 5. Number of participants with Adverse Events [ Time Frame: Up to 50 months ]
  • 6. Number of participants with physical examination abnormalities [ Time Frame: Up to 50 months ]
  • 7. Number of participants with vital sign abnormalities [ Time Frame: Up to 50 months ]
  • 8. Number of participants with clinical laboratory abnormalities [ Time Frame: Up to 50 months ]
  • 9. Maximum observed plasma concentration (Cmax) [ Time Frame: Up to 27 months ]
  • 10. Time of maximum observed plasma concentration (Tmax) [ Time Frame: Up to 27 months ]
  • 11. Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T)) [ Time Frame: Up to 27 months ]
  • 12. Area under the serum concentration-time curve from time 0 to infinity AUC(INF) [ Time Frame: Up to 27 months ]
  • 13. Number of participant-reported outcomes utilizing the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Scale [ Time Frame: Up to 27 months ]
  • 14. Number of participant-reported outcomes utilizing the EuroQol 5-dimension 5-level questionnaire (EQ-5D-5L) [ Time Frame: Up to 27 months ]

Eligibility Criteria

  • Ages Eligible for Study: 55 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com

Contact: First line of the email MUST contain NCT # and Site #.

Locations

Japan, Aichi
Local Institution
Nagoya

Japan, Aichi
Local Institution
Nagoya

Japan, Aichi
Local Institution
Nagoya

Japan, Aichi
Local Institution
Toyoake

Japan, Chiba
Local Institution
Kamogawa

Japan, Chiba
Local Institution
Kashiwa

Japan, Ehime
Matsuyama Red Cross Hospital
Matsuyama

Japan, Fukui
University of Fukui Hospital
Yoshida gun

Japan, Fukuoka
Local Institution
Fukuoka-shi

Japan, Gifu
Local Institution
Ogaki

Japan, Gunma
Local Institution - 0001
Maebashi

Japan, Hokkaido
Aiiku Hospital
Sapporo

Japan, Ishikawa
Local Institution
Kanazawa

Japan, Kanagawa
Local Institution
Isehara

Japan, Kanagawa
Local Institution
Sagamihara

Japan, Kanagawa
Local Institution
Yokohama

Japan, Miyagi
Local Institution
Sendai-shi

Japan, Osaka
Local Institution
Osaka Sayama

Japan, Saitama
Local Institution
Saitama shi

Japan, Tochigi
Local Institution
Shimotsuke

Japan, Tokyo
Local Institution
Bunkyo Ku

Japan, Tokyo
Local Institution
Shinagawa ku

Japan, Tokyo
Local Institution
Shinjyuku Ku

Japan, Tokyo
Local Institution
Sumida ku

Japan
Local Institution
Aomori

Japan
Local Institution
Fukuoka

Japan
Local Institution
Fukuoka

Japan
Local Institution
Nagasaki

Japan
Local Institution
Okayama

Japan
Local Institution
Osaka

Japan
Local Institution
Yamagata

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

  • Responsible Party: Bristol-Myers Squibb
  • ClinicalTrials.gov Identifier: NCT05197426 History of Changes
  • Other Study ID Numbers: CA055-005
  • First Posted: January 19, 2022 Key Record Dates
  • Last Update Posted: May 27, 2022
  • Last Verified: May 2022
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Product Manufactured in and Exported from the U.S.: Yes
  • Additional relevant MeSH terms: Leukemia
    Leukemia, Myeloid
    Leukemia, Myeloid, Acute
    Neoplasms by Histologic Type
    Neoplasms