Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2024-514341-10-00 | Registry Identifier | EUCT number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JNJ-90189892: Monotherapy | Experimental | Participants 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. |
|
| JNJ-90189892: In Combination with Azacitadine (AZA)+ Venetoclax (VEN) | Experimental | Participants 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-90189892 | Drug | JNJ-90189892 will be administered. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From screening untill 30 days after last dose of study drug (that is approximately 2.5 years) |
| 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. | At least 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Concentration of JNJ-90189892 | Serum samples will be analyzed to determine concentrations of JNJ-90189892. | Up to approximately 2.5 years |
| Area Under the Curve Over a Dosing Interval (AUC tau) of JNJ-90189892 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Contact | Contact | 844-434-4210 | Participate-In-This-Study1@its.jnj.com |
| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Concord Hospital | Recruiting | Concord | 2139 | Australia | ||
| Peter MacCallum Cancer Centre |
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Azacitadine (AZA) | Drug | AZA will be administered. |
|
| Venetoclax (VEN) | Drug | VEN will be administered. |
|
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.
| Up to approximately 2.5 years |
| 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. | Up to approximately 2.5 years |
| 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. | Up to approximately 2.5 years |
| Number of Participants with Presence of Anti-JNJ-90189892 Antibodies | Participants with presence of anti-JNJ-90189892 antibodies will be reported. | Up to approximately 2.5 years |
| 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. | Up to approximately 2.5 years |
| 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. | Up to approximately 2.5 years |
| 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. | Up to approximately 2.5 years |
| 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. | Up to approximately 2.5 years |
| Time to Response (TTR) | TTR is defined for responders, as the time from the first dose of study drug to first qualifying response. | Up to approximately 2.5 years |
| 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. | Up to approximately 2.5 years |
| 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. | Up to approximately 2.5 years |
| 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. | Up to approximately 2.5 years |
| Recruiting |
| Melbourne |
| 3000 |
| Australia |
| Sir Charles Gairdner Hospital | Recruiting | Nedlands | 6009 | Australia |
| Institut Paoli-Calmettes | Recruiting | Marseille | 13273 | France |
| CHRU de Strasbourg - Hopital de Hautepierre | Recruiting | Strasbourg | 67200 | France |
| Institut Claudius Regaud | Recruiting | Toulouse | 31100 | France |
| Hosp Univ Fund Jimenez Diaz | Recruiting | Madrid | 28040 | Spain |
| Clinica Univ. de Navarra | Recruiting | Pamplona | 31008 | Spain |
| Hospital Universitario Virgen Rocio | Recruiting | Seville | 41013 | Spain |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C579720 | venetoclax |
Not provided
Not provided
Not provided