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 recruitment status First Posted Last update posted
NCT05197426 Recruiting January 19, 2022 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
Investigator
Study Director : Bristol-Myers Squibb Bristol-Myers Squibb
More Information
Responsible Party : Bristol-Myers Squibb
ClinicalTrials.gov Identifier : NCT05197426     
Other Study ID Numbers : CA055-005
First Posted : January 19, 2022
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