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 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05400122 -
Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer
|
Phase 1 | |
| Recruiting |
NCT04460235 -
Immunogenicity of an Anti-pneumococcal Combined Vaccination in Acute Leukemia or Lymphoma
|
Phase 4 | |
| Completed |
NCT04022785 -
PLX51107 and Azacitidine in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome
|
Phase 1 | |
| Completed |
NCT03678493 -
A Study of FMT in Patients With AML Allo HSCT in Recipients
|
Phase 2 | |
| Recruiting |
NCT05424562 -
A Study to Assess Change in Disease State in Adult Participants With Acute Myeloid Leukemia (AML) Ineligible for Intensive Chemotherapy Receiving Oral Venetoclax Tablets in Canada
|
||
| Completed |
NCT03197714 -
Clinical Trial of OPB-111077 in Patients With Relapsed or Refractory Acute Myeloid Leukaemia
|
Phase 1 | |
| Terminated |
NCT03224819 -
Study of Emerfetamab (AMG 673) in Adults With Relapsed/Refractory Acute Myeloid Leukemia (AML)
|
Early Phase 1 | |
| Active, not recruiting |
NCT03844048 -
An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial
|
Phase 3 | |
| Active, not recruiting |
NCT04070768 -
Study of the Safety and Efficacy of Gemtuzumab Ozogamicin (GO) and Venetoclax in Patients With Relapsed or Refractory CD33+ Acute Myeloid Leukemia:Big Ten Cancer Research Consortium BTCRC-AML17-113
|
Phase 1 | |
| Active, not recruiting |
NCT04107727 -
Trial to Compare Efficacy and Safety of Chemotherapy/Quizartinib vs Chemotherapy/Placebo in Adults FMS-like Tyrosine Kinase 3 (FLT3) Wild-type Acute Myeloid Leukemia (AML)
|
Phase 2 | |
| Recruiting |
NCT04920500 -
Bioequivalence of Daunorubicin Cytarabine Liposomes in Naive AML Patients
|
N/A | |
| Recruiting |
NCT04385290 -
Combination of Midostaurin and Gemtuzumab Ozogamicin in First-line Standard Therapy for Acute Myeloid Leukemia (MOSAIC)
|
Phase 1/Phase 2 | |
| Recruiting |
NCT03897127 -
Study of Standard Intensive Chemotherapy Versus Intensive Chemotherapy With CPX-351 in Adult Patients With Newly Diagnosed AML and Intermediate- or Adverse Genetics
|
Phase 3 | |
| Active, not recruiting |
NCT04021368 -
RVU120 in Patients With Acute Myeloid Leukemia or High-risk Myelodysplastic Syndrome
|
Phase 1 | |
| Recruiting |
NCT03665480 -
The Effect of G-CSF on MRD After Induction Therapy in Newly Diagnosed AML
|
Phase 2/Phase 3 | |
| Completed |
NCT02485535 -
Selinexor in Treating Patients With Intermediate- and High-Risk Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome After Transplant
|
Phase 1 | |
| Enrolling by invitation |
NCT04093570 -
A Study for Participants Who Participated in Prior Clinical Studies of ASTX727 (Standard Dose), With a Food Effect Substudy at Select Study Centers
|
Phase 2 | |
| Recruiting |
NCT04069208 -
IA14 Induction in Young Acute Myeloid Leukemia
|
Phase 2 | |
| Recruiting |
NCT05744739 -
Tomivosertib in Relapsed or Refractory Acute Myeloid Leukemia (AML)
|
Phase 1 | |
| Recruiting |
NCT04969601 -
Anti-Covid-19 Vaccine in Children With Acute Leukemia and Their Siblings
|
Phase 1/Phase 2 |