Acute Myeloid Leukemia Clinical Trial
Official title:
Phase I Multicenter, Open-Label, First-in-Human Study of BMS-986497 (ORM-6151) in Subjects With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome
The purpose of this study is to assess the safety, tolerability, drug levels, drug efficacy and determine the recommended dose of BMS-986497 in participants with relapsed or refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).
| Status | Not yet recruiting |
| Enrollment | 35 |
| Est. completion date | September 16, 2030 |
| Est. primary completion date | February 1, 2027 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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/exclusion criteria apply. |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Local Institution - 0003 | Montreal | Quebec |
| Canada | Local Institution - 0002 | Toronto | Ontario |
| United States | Local Institution - 0007 | Boston | Massachusetts |
| United States | Local Institution - 0014 | Boston | Massachusetts |
| United States | Local Institution - 0010 | Chicago | Illinois |
| United States | Local Institution - 0009 | Fairfax | Virginia |
| United States | Local Institution - 0008 | Hackensack | New Jersey |
| United States | Local Institution - 0006 | Houston | Texas |
| United States | Local Institution - 0011 | New Haven | Connecticut |
| United States | Columbia University Irving Medical Center | New York | New York |
| United States | Local Institution - 0013 | Saint Louis | Missouri |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
United States, Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence of dose-limiting toxicities (DLTs) | Up to 21 days | ||
| Primary | Incidence of treatment-emergent adverse events (TEAEs) | Up to 2 years | ||
| Primary | Determine the Recommended Phase 2 Dose (RP2D) | Up to 2 years | ||
| Secondary | Maximum concentration (Cmax) | Up to 2 years | ||
| Secondary | Time to reach Cmax (Tmax) | Up to 2 years | ||
| Secondary | Area under the curve from time 0 to last quantifiable concentration (AUC0-last) | Up to 2 years | ||
| Secondary | Overall response rate (ORR) | Up to 4 years | ||
| Secondary | Duration of response (DoR) | Up to 4 years | ||
| Secondary | Best overall response (BOR) | Up to 4 years | ||
| Secondary | Complete remission (CR) | Up to 4 years | ||
| Secondary | Complete remission with incomplete hematologic recovery (Cri) | Up to 4 years | ||
| Secondary | Complete remission with partial hematologic recovery (CRh) rate | Up to 4 years | ||
| Secondary | Event-free survival (EFS) | Up to 4 years | ||
| Secondary | Transition rate to allogeneic hematopoietic stem cell transplantation (HSCT) | Up to 4 years | ||
| Secondary | Incidence of Anti-drug antibody (ADA) against BMS-986497 | Up to 2 years |
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|---|---|---|---|
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