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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-519537-29 | Other Identifier | EU CTR |
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The purpose of this study is to assess the safety, tolerability, drug levels, drug efficacy and determine the recommended dose of BMS-986497 as a monotherapy, in double combination with Azacitidine and in triple combination with Azacitidine and Venetoclax in participants with relapsed or refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Dose Escalation BMS-986497 (Monotherapy) | Experimental |
| |
| Part 2, Cohort A: Dose Expansion BMS-986497 (Combination Therapy) | Experimental |
| |
| Part 2, Cohort B: Dose Expansion BMS-986497 (Triple Combination Therapy) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986497 | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of dose-limiting toxicities (DLTs) | Up to 21 days | |
| Incidence of treatment-emergent adverse events (TEAEs) | Up to 2 years | |
| Determine the Recommended Phase 2 Dose (RP2D) of BMS-986497 as Monotherapy | Up to 2 years | |
| RP2D of BMS-986497 as Combination Therapy | The combination therapy included BMS-986497 and Azacitidine | Up to 2 years |
| RP2D of BMS-986497 as Triple Combination Therapy | The triple combination therapy included BMS-986497, Azacitidine and Venetoclax. | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum concentration (Cmax) | Up to 2 years | |
| Time to reach Cmax (Tmax) | Up to 2 years | |
| Area under the curve from time 0 to last quantifiable concentration (AUC0-last) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| BMS Clinical Trials Contact Center www.BMSClinicalTrials.com | Contact | 855-907-3286 | Clinical.Trials@bms.com | |
| First line of the email MUST contain NCT # and Site #. | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale-New Haven Hospital | Recruiting | New Haven | Connecticut | 06510 | United States |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
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BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
See Plan Description
See Plan Description
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|
| Azacitidine | Drug | Specified dose on specified days |
|
| Venetoclax | Drug | Specified dose on specified days |
|
| Up to 2 years |
| Overall response rate (ORR) | Up to 4 years |
| Duration of response (DoR) | Up to 4 years |
| Best overall response (BOR) | Up to 4 years |
| Complete remission (CR) | Up to 4 years |
| Complete remission with incomplete hematologic recovery (Cri) | Up to 4 years |
| Complete remission with partial hematologic recovery (CRh) rate | Up to 4 years |
| Event-free survival (EFS) | Up to 4 years |
| Transition rate to allogeneic hematopoietic stem cell transplantation (HSCT) | Up to 4 years |
| Incidence of Anti-drug antibody (ADA) against BMS-986497 | Up to 2 years |
| Northwestern Memorial Hospital | Recruiting | Chicago | Illinois | 60611 | United States |
|
| Local Institution - 0007 | Withdrawn | Boston | Massachusetts | 02114 | United States |
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
|
| Washington University School of Medicine, Siteman Cancer Center | Recruiting | St Louis | Missouri | 63108 | United States |
|
| John Theurer Cancer Center at Hackensack University Medical Center | Recruiting | Hackensack | New Jersey | 07601 | United States |
|
| Columbia University Irving Medical Center | Withdrawn | New York | New York | 10032 | United States |
| University of Texas MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
|
| Local Institution - 0009 | Withdrawn | Fairfax | Virginia | 22031 | United States |
| Princess Margaret Cancer Centre | Recruiting | Toronto | Ontario | M5G 2M9 | Canada |
|
| Jewish General Hospital | Recruiting | Montreal | Quebec | H3T 1E2 | Canada |
|
| Local Institution - 0017 | Not yet recruiting | Marseille | Bouches-du-Rhône | 13273 | France |
|
| Local Institution - 0018 | Not yet recruiting | Paris | 75010 | France |
|
| Local Institution - 0022 | Not yet recruiting | Toulouse | 31100 | France |
|
| Hospital Clínic de Barcelona | Recruiting | Barcelona | Catalunya [Cataluña] | 08036 | Spain |
|
| Hospital Universitario Virgen Del Rocio | Recruiting | Seville | 41013 | Spain |
|
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D009190 | Myelodysplastic Syndromes |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D001855 | Bone Marrow Diseases |
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| ID | Term |
|---|---|
| D001374 | Azacitidine |
| C579720 | venetoclax |
| ID | Term |
|---|---|
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
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