Study of BMS-986497 (ORM-6151) as a Monotherapy, in Double and Triple Combination With Azacitidine and Venetoclax in Participants With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BMS-986497, Azacitidine, Venetoclax.
- Who it may be relevant to
- Registry conditions: Acute Myeloid Leukemia, Myelodysplastic Syndrome. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Canada, France, Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Phase I Multicenter, Open-Label, First-in-Human Study of BMS-986497 (ORM-6151) as a Monotherapy, in Double Combination With Azacitidine and in Triple Combination With Azacitidine and Venetoclax in Subjects With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome
Overview
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
- Drug BMS-986497
Specified dose on specified days - Drug Azacitidine
Specified dose on specified days - Drug Venetoclax
Specified dose on specified days
Primary outcome measures
- Incidence of dose-limiting toxicities (DLTs) [Time frame: Up to 21 days]
- Incidence of treatment-emergent adverse events (TEAEs) [Time frame: Up to 2 years]
- Determine the Recommended Phase 2 Dose (RP2D) of BMS-986497 as Monotherapy [Time frame: Up to 2 years]
- RP2D of BMS-986497 as Combination Therapy [Time frame: Up to 2 years]
- RP2D of BMS-986497 as Triple Combination Therapy [Time frame: Up to 2 years]
Secondary outcome measures (12)
- Maximum concentration (Cmax) [Time frame: Up to 2 years]
- Time to reach Cmax (Tmax) [Time frame: Up to 2 years]
- Area under the curve from time 0 to last quantifiable concentration (AUC0-last) [Time frame: Up to 2 years]
- Overall response rate (ORR) [Time frame: Up to 4 years]
- Duration of response (DoR) [Time frame: Up to 4 years]
- Best overall response (BOR) [Time frame: Up to 4 years]
- Complete remission (CR) [Time frame: Up to 4 years]
- Complete remission with incomplete hematologic recovery (Cri) [Time frame: Up to 4 years]
- Complete remission with partial hematologic recovery (CRh) rate [Time frame: Up to 4 years]
- Event-free survival (EFS) [Time frame: Up to 4 years]
- Transition rate to allogeneic hematopoietic stem cell transplantation (HSCT) [Time frame: Up to 4 years]
- Incidence of Anti-drug antibody (ADA) against BMS-986497 [Time frame: Up to 2 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 9 centers
- Yale-New Haven Hospital — New Haven
- Northwestern Memorial Hospital — Chicago
- Local Institution - 0007 — Boston
- Massachusetts General Hospital — Boston
- Washington University School of Medicine, Siteman Cancer Center — St Louis
- John Theurer Cancer Center at Hackensack University Medical Center — Hackensack
- Columbia University Irving Medical Center — New York
- University of Texas MD Anderson Cancer Center — Houston
- … and 1 more center
France · 3 centers
- Local Institution - 0017 — Marseille
- Local Institution - 0018 — Paris
- Local Institution - 0022 — Toulouse
Canada · 2 centers
- Princess Margaret Cancer Centre — Toronto
- Jewish General Hospital — Montreal
Spain · 2 centers
- Hospital Clínic de Barcelona — Barcelona
- Hospital Universitario Virgen Del Rocio — Seville
Identifiers
NCT: NCT06419634 · CA235-0001 · 2024-519537-29