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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

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ClinicalTrials.gov Identifier: NCT05197426
Recruitment Status : Recruiting
First Posted : January 19, 2022
Last Update Posted : May 27, 2022
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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 Intervention/treatment Phase
Acute Myeloid Leukemia Drug: Oral Azacitidine Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : January 17, 2022
Estimated Primary Completion Date : June 24, 2024
Estimated Study Completion Date : April 11, 2026


Arm Intervention/treatment
Experimental: Oral Azacitidine Drug: Oral Azacitidine
Specified dose on specified days
Other Names:
  • CC-486
  • BMS-986345

Placebo Comparator: Placebo Other: Placebo
Specified dose of specified days




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 ]


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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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05197426


Contacts
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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
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Japan
Local Institution Not yet recruiting
Nagoya, Aichi, Japan, 4538511
Contact: Site 0017         
Local Institution Not yet recruiting
Nagoya, Aichi, Japan, 4648681
Contact: Site 0011         
Local Institution Not yet recruiting
Nagoya, Aichi, Japan, 4668560
Contact: Site 0023         
Local Institution Not yet recruiting
Toyoake, Aichi, Japan, 4701192
Contact: Site 0009         
Local Institution Not yet recruiting
Kamogawa, Chiba, Japan, 2968602
Contact: Site 0005         
Local Institution Not yet recruiting
Kashiwa, Chiba, Japan, 277-8577
Contact: Site 0003         
Matsuyama Red Cross Hospital Recruiting
Matsuyama, Ehime, Japan, 7900826
Contact: Tomoaki Fujisaki, Site 0010    810899241111      
University of Fukui Hospital Recruiting
Yoshida gun, Fukui, Japan, 910113
Contact: Naoko Hosono, Site 0020    81779108507      
Local Institution Not yet recruiting
Fukuoka-shi, Fukuoka, Japan, 810-8539
Contact: Site 0016         
Local Institution Not yet recruiting
Ogaki, Gifu, Japan, 503-8502
Contact: Site 0014         
Local Institution - 0001 Recruiting
Maebashi, Gunma, Japan, 3710821
Contact: Site 0001         
Aiiku Hospital Recruiting
Sapporo, Hokkaido, Japan, 064-0804
Contact: Takeshi Kondo, Site 0004    810364537311      
Local Institution Not yet recruiting
Kanazawa, Ishikawa, Japan, 9208641
Contact: Site 0019         
Local Institution Not yet recruiting
Isehara, Kanagawa, Japan, 2591193
Contact: Site 0012         
Local Institution Not yet recruiting
Sagamihara, Kanagawa, Japan, 2520375
Contact: Site 0006         
Local Institution Not yet recruiting
Yokohama, Kanagawa, Japan, 2360004
Contact: Site 0013         
Local Institution Not yet recruiting
Sendai-shi, Miyagi, Japan, 9808574
Contact: Site 0015         
Local Institution Not yet recruiting
Osaka Sayama, Osaka, Japan, 5898511
Contact: Site 0021         
Local Institution Not yet recruiting
Saitama shi, Saitama, Japan, 3308503
Contact: Site 0028         
Local Institution Not yet recruiting
Shimotsuke, Tochigi, Japan, 3290498
Contact: Site 0031         
Local Institution Not yet recruiting
Bunkyo Ku, Tokyo, Japan, 1138677
Contact: Site 0032         
Local Institution Not yet recruiting
Shinagawa ku, Tokyo, Japan, 1418625
Contact: Site 0002         
Local Institution Not yet recruiting
Shinjyuku Ku, Tokyo, Japan, 1600023
Contact: Site 0030         
Local Institution Not yet recruiting
Sumida ku, Tokyo, Japan, 1308575
Contact: Site 0029         
Local Institution Not yet recruiting
Aomori, Japan, 030-8553
Contact: Site 0022         
Local Institution Not yet recruiting
Fukuoka, Japan, 810-8563
Contact: Site 0018         
Local Institution Not yet recruiting
Fukuoka, Japan, 8120033
Contact: Site 0027         
Local Institution Not yet recruiting
Nagasaki, Japan, 8528511
Contact: Site 0008         
Local Institution Not yet recruiting
Okayama, Japan, 7008558
Contact: Site 0025         
Local Institution Not yet recruiting
Osaka, Japan, 5300012
Contact: Site 0026         
Local Institution Not yet recruiting
Yamagata, Japan, 990-9585
Contact: Site 0007         
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT05197426    
Other Study ID Numbers: CA055-005
First Posted: January 19, 2022    Key Record Dates
Last Update Posted: May 27, 2022
Last Verified: May 2022

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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:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Azacitidine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors