Acute Myeloid Leukemia Clinical Trial
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
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.
| 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 |
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
United States, Japan,
| 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 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Suspended |
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