Hematologic neoplasms, blood cancer Cancer
Conditions
Interventions
Arm A: R/R Acute Myeloid Leukaemia (AML)/ High-Risk Myelodysplastic Syndrome (HR MDS)
Participants with relapsed/refractory (R/R) AML/HR-MDS will receive JNJ-95804306 monotherapy (Arm A1) or as an ad
Sponsors
Janssen-Cilag International NV
Eligibility
Sex/Gender
All
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: For Arm A: 1. Have a diagnosis of: Acute myeloid leukemia (AML) per International Consensus Classification (ICC) 2022 or myelodysplastic syndromes (MDS) per world health organization (WHO) 2022 classified as moderate high, high, or very high-risk per the molecular international prognostic scoring system (IPSSM). All participants must have relapsed or refractory disease and have exhausted or are ineligible for standard therapeutic options 2. Body weight greater than or equal to (>=) 40 kilograms (kg) 3. Eastern cooperative oncology group (ECOG) performance status of 0 to 2 For Arm B: 1. Have a diagnosis of chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) that meets international workshop on chronic lymphocytic leukemia (iwCLL), National cancer institute (NCI) Working Group Guidelines which is relapsed or refractory and requires treatment with no other approved therapies available that would be more appropriate in the investigator’s judgment. 1.1. Participants must have received at least 2 prior lines of therapy 1.2. Participants who have received at least one prior line of therapy but are not eligible or do not have access to standard second line therapies, will be allowed to enroll 2. Body weight >= 40 kg 3. ECOG performance status of 0 to 2 4. Have clinically measurable disease
Exclusion criteria
Exclusion criteria: For Arm A: 1. Has acute promyelocytic leukemia according to world health organization (WHO) 2016 criteria or known active central nervous system (CNS) involvement of AML/MDS, unless in specific cohort (s) per study evaluation team (SET) decision 2. Need for supplemental oxygen use to maintain adequate oxygenation 3. Have evidence of uncontrolled systemic viral, bacterial, or fungal infection. Antimicrobial prophylaxis is permitted For Arm B: 1. Need for supplemental oxygen use to maintain adequate oxygenation 2. Have evidence of uncontrolled systemic viral, bacterial, or fungal infection requiring initiation of parenteral treatment as medical intervention 3. Developed Richter's transformation or prolymphocytic leukemia 4. Known active CNS or leptomeningeal involvement of CLL/SLL
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Part 1: Number of Participants with Dose Limiting Toxicities (DLTs) A DLT is defined as any toxicity that requires discontinuation of treatment; any Grade 5 toxicity; Non-hematologic Toxicity (Grade 3 or 4); and unacceptable hematologic toxicity. Up to 21 days after first full dose of study drug 2. Number of Participants with Adverse Events (AEs) by Severity An AE is any untoward medical occurrence in a participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the treatment. Severity of AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCICTCAE) version (v) 6.0. by using standard grades as follows: Grade 1: Mild; asymptomatic or mild symptoms; Grade 2: Moderate; minimal, local or noninvasive intervention indicated; Grade 3: Severe but not immediately life threatening; hospitalization or prolongation of hospitalization indicated; Grade 4: Life-threatening consequences; and Grade 5: Death related to AE. Up to 6 years 5 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Up to approximately 6 years 5 months 1. Serum Concentrations of JNJ-95804306 Serum samples will be analyzed to determine concentrations of JNJ-95804306. 2. Area Under the Curve From Time of Administration until End of Dosing Interval (AUC[t]) of JNJ-95804306 AUC[t] is defined as the area under the plasma concentration time curve during a dosing interval at steady-state. 3. Maximum Plasma Concentration (Cmax) of JNJ-95804306 Cmax is defined as the maximum serum concentration of JNJ-95804306. 4. Minimum Plasma Concentration (Cmin) of JNJ-95804306 Cmin is defined as the minimum plasma concentration of JNJ-95804306. 5. Complete Response (CR) in Participants with Acute Myeloid Leukemia (AML) Complete response (CR) is achieved when a participant with AML has a best response of CR (complete response with partial hematologic recovery [CRh] or complete response with incomplete hematologic recovery [CRi]) according to the European Leukemia Network (ELN) 2022 criteria. 6. Overall Response (OR) in Participants with Myelodysplastic Syndrome (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. 7. Complete Response (CR) in Participants with MDS CR is achieved when a participant with MDS has a best response of CR (including CRh/CRL) according to the IWG 2023 criteria. 8. Overall Response (OR) in Participants with Chronic Lymphocytic Leukemia (CLL) OR is achieved when a participant with CLL has a CR or PR according to the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria. 9. Complete Response in Participants with CLL Complete response as per iwCLL response criteria will be reported. 10. Overall Response in Participants with Small Lymphocytic Lymphoma (SLL) Overall response in participants with SLL is achieved when a participant with SLL has a CR or PR accordi | — |
Countries
Australia, Belgium, Denmark, France, Germany, Spain, United Kingdom, United States of America
Contacts
Public ContactEllice;- Marwood;Medical Information and Product Information Enquiry
;
Outcome results
None listed