Actively Recruiting
A Study of JNJ-90189892 for Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms
Led by Janssen Research & Development, LLC · Updated on 2026-05-08
155
Participants Needed
9
Research Sites
191 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of Part 1 (Dose Escalation) of the study is to assess the effective dose (recommended Phase 2 dose\[s\] \[RP2Ds\]) that can be safely administered, and dosing regimens of JNJ-90189892 in participants with relapsed or refractory (R/R) acute myeloid leukemia (AML) or R/R higher-risk type of myelodysplastic neoplasms (MDS \[type of cancer of the blood and bone marrow, which does not respond to treatment or comes back after treatment\]). The purpose of Part 2 (Cohort Expansion) is to further assess the safety, tolerability and efficacy in participants with R/R AML or higher-risk types of MDS at the RP2D regimen(s). The purpose of Part 3 and 4 is to assess the effective dose (recommended Phase 2 combination dose \[RP2CD\]) that can be safely administered, and dosing regimens of JNJ-90189892 in combination with azacitadine (AZA) + venetoclax (VEN) in participants with R/R AML (part 3) and newly diagnosed (ND) AML (part 4).
CONDITIONS
Official Title
A Study of JNJ-90189892 for Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of acute myeloid leukemia (AML) or higher-risk myelodysplastic neoplasms (MDS) per WHO 2022 criteria for Parts 1, 2, and 3
- Previously untreated acute myeloid leukemia (AML) for Part 4 only
- Body weight of at least 40 kg
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Adequate kidney function with estimated glomerular filtration rate (eGFR) of 40 mL/min or higher
- Laboratory test results within required ranges
You will not qualify if you...
- History of serious lung problems or current need for supplemental oxygen
- Uncontrolled viral, bacterial, or fungal infections (antimicrobial prevention allowed)
- Known allergies or intolerance to JNJ-90189892 or its ingredients; for Parts 3 and 4, also allergies to venetoclax (VEN), azacitadine (AZA), or their ingredients
- Major surgery or significant injury within 14 days before starting treatment
- Previous or current second cancer likely to affect study results
- Known active involvement of the central nervous system
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
Concord Hospital
Concord, Australia, 2139
Actively Recruiting
2
Peter MacCallum Cancer Centre
Melbourne, Australia, 3000
Actively Recruiting
3
Sir Charles Gairdner Hospital
Nedlands, Australia, 6009
Actively Recruiting
4
Institut Paoli-Calmettes
Marseille, France, 13273
Actively Recruiting
5
Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre
Strasbourg, France, 67200
Actively Recruiting
6
Institut Claudius Regaud
Toulouse, France, 31100
Actively Recruiting
7
Hosp Univ Fund Jimenez Diaz
Madrid, Spain, 28040
Actively Recruiting
8
Clinica Univ. de Navarra
Pamplona, Spain, 31008
Actively Recruiting
9
Hospital Universitario Virgen Rocio
Seville, Spain, 41013
Actively Recruiting
Research Team
S
Study Contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here