AzTrials
AzTrials

Leukemia, Myeloid, AcutePhase 1NCT06651229

A Study of JNJ-90189892 for Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms

A Phase 1 study testing JNJ-90189892, Azacitadine (AZA) and Venetoclax (VEN) in people with Leukemia, Myeloid, Acute and Myelodysplastic Neoplasms, run by Janssen Research & Development, LLC at 9 sites in 3 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
JNJ-90189892, Azacitadine (AZA) and Venetoclax (VEN)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
85 participants
Where
9 sitesin 3 countries
Study dates
21 Mar 2025to 9 Feb 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • A. For Parts 1, 2, and 3: Have a diagnosis, per the world health organization (WHO) 2022 criteria, of (a) Parts 1, 2, and 3: Acute myeloid leukemia (AML) or (b) Parts 1 and 2: Moderate high, high, or very high-risk myelodysplastic neoplasms (MDS) per Molecular International Prognostic Scoring System (IPSS-M); B. For Part 4 only: Previously untreated acute myeloid leukemia (AML) per the WHO 2022 criteria
  • Body weight that is greater than or equals to (>=) 40 kg
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  • Have adequate renal function defined as Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Estimated Glomerular Filtration Rate (eGFR) >=40 milligrams per minute (mL/min) computed with the calculator on the national kidney foundation website
  • Participants must have laboratory parameters in the required range

Who cannot join

  • Has a medical history of clinically significant pulmonary compromise, particularly the current need for supplemental oxygen use to maintain adequate oxygenation
  • Has evidence of uncontrolled systemic viral, bacterial, or fungal infection. Antimicrobial prophylaxis is permitted
  • All participants- Has known allergies, hypersensitivity, or intolerance to JNJ-90189892 or its excipients; Parts 3 and 4- Has known allergies, hypersensitivity, or intolerance to venetoclax (VEN), azacitadine (AZA), or their excipients
  • Had major surgery or had significant traumatic injury within 14 days of planned first dose of JNJ-90189892
  • Had a prior or concurrent second malignancy with natural history or treatment likely to interfere with any study endpoints of safety or the efficacy of the study treatment
  • Has known active central nervous system involvement

Trial locations and contacts

9 sites in 3 countries.

9 sites in 3 countries

Australia3 sites

  • Concord Hospital

    Concord, 2139

  • Peter MacCallum Cancer Centre

    Melbourne, 3000

  • Sir Charles Gairdner Hospital

    Nedlands, 6009

Other trials in Australia

France3 sites

  • Institut Paoli-Calmettes

    Marseille, 13273

  • CHRU de Strasbourg - Hopital de Hautepierre

    Strasbourg, 67200

  • Institut Claudius Regaud

    Toulouse, 31100

Other trials in France

Spain3 sites

  • Hosp Univ Fund Jimenez Diaz

    Madrid, 28040

  • Clinica Univ. de Navarra

    Pamplona, 31008

  • Hospital Universitario Virgen Rocio

    Seville, 41013

Other trials in Spain

About this study

Official title: A Phase 1, First-in-Human, Dose Escalation Study of JNJ-90189892 for Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms

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).

Being tested
JNJ-90189892, Azacitadine (AZA), Venetoclax (VEN)
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JNJ-90189892Drug

    JNJ-90189892 will be administered.

  • Azacitadine (AZA)Drug

    AZA will be administered.

  • Venetoclax (VEN)Drug

    VEN will be administered.

Study groups in NCT06651229
Study groupRoleWhat they receive
JNJ-90189892: MonotherapyExperimentalParticipants will receive JNJ-90189892 in Part 1 (Dose escalation) of the study and the dose levels will be escalated sequentially based on the decisions of the study evaluation team (SET) until the recommended phase 2 dose (RP2D) has been identified. Participants in Part 2 (Dose expansion) will receive JNJ-90189892 at the RP2D determined in Part 1.
Receives: Drug: JNJ-90189892
JNJ-90189892: In Combination with Azacitadine (AZA)+ Venetoclax (VEN)ExperimentalParticipants with relapsed or refractory (R/R) acute myeloid leukemia (AML) in Part 3 will receive JNJ-90189892+ AZA+VEN to determine the recommended Phase 2 combination dose (RP2CD). The starting JNJ-90189892 dose regimen in Part 3 will be at least 1 dose level below the highest dose level cleared in Part 1 as determined by the SET. In Part 4 participants with newly diagnosed (ND) AML will receive JNJ-90189892+ AZA+VEN starting from the JNJ-90189892 dose level determined safe in Part 3 by the SET.
Receives: Drug: JNJ-90189892; Drug: Azacitadine (AZA); Drug: Venetoclax (VEN)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants with Adverse events (AEs) by Severity

    An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.

    Measured: From screening untill 30 days after last dose of study drug (that is approximately 2.5 years)

  2. Part 1: Number of Participants with Dose-Limiting Toxicity (DLTs)

    DLT is defined as any toxicity that requires discontinuation of treatment, any Grade 5 toxicity; Non-hematologic toxicity (Grade 3 or 4) and Hematologic toxicity.

    Measured: At least 14 days

Secondary outcomes (13)

  1. Serum Concentration of JNJ-90189892

    Serum samples will be analyzed to determine concentrations of JNJ-90189892.

    Measured: Up to approximately 2.5 years

  2. Area Under the Curve Over a Dosing Interval (AUC tau) of JNJ-90189892

    AUC tau is the total observed plasma concentration of JNJ-90189892 in the body during the time between doses. AUCtau of JNJ-90189892 will be reported.

    Measured: Up to approximately 2.5 years

  3. Maximum Observed Plasma Concentration (Cmax) of JNJ-90189892

    Cmax is the maximum observed plasma concentration of JNJ-90189892. Cmax of JNJ-90189892 will be reported.

    Measured: Up to approximately 2.5 years

  4. Minimum Observed Plasma Concentration (Cmin) of JNJ-90189892

    Cmin is the minimum observed plasma concentration of JNJ-90189892. Cmin of JNJ-90189892 will be reported.

    Measured: Up to approximately 2.5 years

  5. Number of Participants with Presence of Anti-JNJ-90189892 Antibodies

    Participants with presence of anti-JNJ-90189892 antibodies will be reported.

    Measured: Up to approximately 2.5 years

  6. Complete Response (CR) in Acute Myeloid Leukemia (AML)

    CR is achieved when a participant has a best response of CR (including complete response with partial hematologic recovery [CRh] or complete response with incomplete hematologic recovery [CRi]) according to the European Leukemia Network (ENL) 2022 criteria.

    Measured: Up to approximately 2.5 years

  7. Overall Response (OR) in Myelodysplastic Neoplasms (MDS)

    OR is achieved when a participant with MDS has a CR (any type, that is CRh or complete response with limited count recovery [CRL]), partial response (PR), or hematologic improvement (HI) according to the International Working Group (IWG) 2023 criteria.

    Measured: Up to approximately 2.5 years

  8. Complete Response in MDS

    CR is achieved when a participant has a best response of CR (including CRh/CRL) according to the IWG 2023 criteria.

    Measured: Up to approximately 2.5 years

  9. Duration of Response (DOR)

    DOR is defined for responsders only, as time from date of initial documentation of a response to the first documented evidence of no reponse, disease progression, relapse, initation of a new systemic anti-cancer therapy (besides hematopoietic stem cell transplant [HSCT]), or death, whichever comes first.

    Measured: Up to approximately 2.5 years

  10. Time to Response (TTR)

    TTR is defined for responders, as the time from the first dose of study drug to first qualifying response.

    Measured: Up to approximately 2.5 years

  11. Number of Participants Achieving Transfusion Independence

    Transfusion independence is defined as the absence of red blood cell (RBC) and platelet transfusions for 8 weeks or longer after starting study treatment for participants with AML and 16 weeks or longer for participants with MDS.

    Measured: Up to approximately 2.5 years

  12. Part 4 Only: Overall Survival (OS)

    OS is defined as the time from the date of first dose of study treatment to the date of death due to any cause.

    Measured: Up to approximately 2.5 years

  13. Part 4 Only: Event-Free Survival (EFS)

    EFS is defined as the time from the date of first dose of study treatment to the date of first documented evidence of treatment failure, relapse or death due to any cause, whichever occurs first.

    Measured: Up to approximately 2.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2024
  2. Study start21 Mar 2025
  3. Primary completion5 Aug 2027 (estimated)
  4. Study completion9 Feb 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
85 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06651229
Sponsor's protocol ID
90189892AML1001
Other IDs
2024-514341-10-00
Status last verified
Nov 2026
First submitted
18 Oct 2024
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The data sharing policy of Johnson \& Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing JNJ-90189892, Azacitadine (AZA) and Venetoclax (VEN) in people with Leukemia, Myeloid, Acute and Myelodysplastic Neoplasms, run by Janssen Research & Development, LLC at 9 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Australia, France, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Adverse events (AEs) by Severity (time frame: From screening untill 30 days after last dose of study drug (that is approximately 2.5 years)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06651229.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in