Acute Myeloid Leukemia, Myelodysplastic Syndrome
Conditions
Keywords
BMS-986497, First-in-Human, ORM-6151, Acute myeloid leukemia (AML), Myelodysplastic syndrome (MDS), Cluster of differentiation 33 (CD33), G1 to S phase transition 1 (GSPT1), Open label study
Brief summary
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).
Interventions
DRUGBMS-986497
Specified dose on specified days
DRUGAzacitidine
Specified dose on specified days
DRUGVenetoclax
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults with primary or secondary relapsed and/or refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). * Detectable levels of cluster of differentiation 33 (CD33) expression. * Failed alternative therapies with established benefit. * Eastern Cooperative Oncology Group (ECOG) performance status ≤2 and adequate organ function.
Exclusion criteria
* Acute Promyelocytic Leukemia. * Clinically active central nervous system leukemia. * Active malignant solid tumor. * Pregnant or breastfeeding. * Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Up to 2 years | The combination therapy included BMS-986497 and Azacitidine |
| RP2D of BMS-986497 as Triple Combination Therapy | Up to 2 years | The triple combination therapy included BMS-986497, Azacitidine and Venetoclax. |
Secondary
| Measure | 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) | 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 |
Countries
Canada, France, Spain, United States
Contacts
CONTACTBMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACTFirst line of the email MUST contain NCT # and Site #.
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed