Janssen Research & Development, LLC Clinical Trial Study Director Janssen Research & Development, LLC
Kontakt
Study Contact Kontakt: Phone: 844-434-4210 E-Mail: Participate-In-This-Study@its.jnj.com» Kontaktdaten anzeigen
Studienlocations (3 von 29)
Charite Universitatsmedizin Berlin 13353 Berlin (Berlin) GermanyRekrutierend» Google-MapsUniversitatsklinikum Carl Gustav Carus Dresden 01307 Dresden (Sachsen) GermanyRekrutierend» Google-MapsUniversitaetsklinikum Heidelberg 69120 Heidelberg (Baden-Württemberg) GermanyRekrutierend» Google-Maps
Universitaetsklinikum Leipzig 04103 Leipzig (Sachsen) GermanyRekrutierend» Google-MapsUniversitatsklinikum Ulm 89081 Ulm (Baden-Württemberg) GermanyRekrutierend» Google-MapsThe University of Alabama at Birmingham 35233 Birmingham United StatesRekrutierend» Google-MapsCity of Hope 91010 Duarte United StatesRekrutierend» Google-MapsMassachusetts General Hospital 02114 Boston United StatesRekrutierend» Google-MapsAlbert Einstein College Of Medicine 10461 New York United StatesRekrutierend» Google-MapsNovant Health 28204 Charlotte United StatesRekrutierend» Google-MapsNovant Health Forsyth Medical Center 27103 Winston-Salem United StatesRekrutierend» Google-MapsMD Anderson 77030 Houston United StatesRekrutierend» Google-MapsMonash Medical Centre 3168 Clayton AustraliaRekrutierend» Google-MapsPeter MacCallum Cancer Centre 3000 Melbourne AustraliaRekrutierend» Google-MapsWestmead Hospital 2145 Westmead AustraliaRekrutierend» Google-MapsInstitut Paoli Calmettes 13273 Marseille Cedex 9 FranceRekrutierend» Google-MapsInstitut Universitaire du Cancer Toulouse Oncopole 31100 Toulouse Cedex 9 FranceRekrutierend» Google-MapsCHU de Tours - Hôpital de Bretonneau 37044 Tours FranceRekrutierend» Google-MapsAzienda Opedaliero-Universitaria Policlinico Sant'orsola Malpighi di Bologna 40138 Bologna ItalyRekrutierend» Google-MapsIstituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori 47014 Meldola ItalyRekrutierend» Google-MapsASST Grande Ospedale Metropolitano Niguarda 20162 Milano ItalyRekrutierend» Google-MapsIRCCS Istituto Clinico Humanitas 20089 Rozzano ItalyRekrutierend» Google-MapsHosp. de La Santa Creu I Sant Pau 08025 Barcelona SpainRekrutierend» Google-MapsHosp. Clinic de Barcelona 08036 Barcelona SpainRekrutierend» Google-MapsHosp. Univ. Vall D Hebron 8035 Barcelona SpainRekrutierend» Google-MapsHosp. Univ. Fund. Jimenez Diaz 28040 Madrid SpainRekrutierend» Google-MapsClinica Univ. de Navarra 31008 Pamplona SpainRekrutierend» Google-MapsUniversity College London Hospitals NHSFT NW1 2PG London United KingdomRekrutierend» Google-MapsChristie Hospital NHS Trust M20 4BX Manchester United KingdomRekrutierend» Google-Maps
1. Number of Participants with Adverse Events (AEs) (Time Frame - Up to 3 Years 3 months): An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
2. Number of Participants with Adverse Events (AEs) by Severity (Time Frame - Up to 3 Years 3 months): Number of Participants with AEs by severity will be reported. 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) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.
3. Number of Participants with Dose-limiting Toxicity (DLT) (Time Frame - End of Cycle 1 (28 days)): Number of participants with DLT will be reported. The DLTs are specific adverse events and are defined per protocol as any of the following: non-hematologic toxicity, or hematologic toxicity.
Secondary outcome:
1. Plasma Concentration of JNJ- 75276617 (Time Frame - Up to 3 Years 3 months): Plasma samples will be analyzed to determine concentrations of JNJ-75276617 using a validated, specific, and sensitive method.
2. Number of Participants with Depletion of Leukemic Blasts (Time Frame - Up to 3 Years 3 months): Number of participants with depletion of leukemic blasts will be reported.
3. Number of Participants with Differentiation of Leukemic Blasts (Time Frame - Up to 3 Years 3 months): Number of participants with differentiation of leukemic blasts will be reported.
4. Changes in Expression of Menin-histone-lysine N-methyltransferase 2A (KMT2A) Target Genes (Time Frame - Up to 3 Years 3 months): Changes in expression of menin-KMT2A target genes will be reported.
5. Percentage of Participants who Achieve Complete Remission (CR) (Time Frame - Up to 3 Years 3 months): Percentage of participants who achieve complete Remission (CR) will be reported. CR is defined as Bone marrow blasts less than (<) 5 percent (%); Absence of circulating blasts and blasts with Auer rods; Absence of extramedullary disease; Absolute neutrophil count (ANC) greater than or equal to (>=) 1.0 x 109/Liter (1,000/microliter [μL] ); Platelet count >= 100 x 109/L (100,000/μL).
6. Percentage of Participants who Achieve Complete Remission with Partial Hematologic Recovery (CRh) (Time Frame - Up to 3 Years 3 months): Percentage of participants who achieve complete remission with partial hematologic recovery (CRh) will be reported. CRh is defined as All criteria of CR with both ANC >0.5 x 109/L (500/μL) and platelet count >50 x 109/L (50,000/μL).
7. Percentage of Participants who Achieve Complete Remission with Incomplete Hematologic Recovery (CRi) (Time Frame - Up to 3 Years 3 months): Percentage of participants who achieve complete remission with incomplete hematologic recovery (CRi) will be reported. CRi is defined as All CR criteria except for residual neutropenia (<1.0 x 109/L [1,000/μL]) or thrombocytopenia (<100 x 109/L [100,000/μL]).
8. Percentage of Participants who Achieved Overall Response (Time Frame - Up to 3 Years 3 months): Percentage of participants who achieve overall response will be reported. Overall response rate (ORR) is defined as the percentage of participants achieving CR, CRh, or CRi.
9. Duration of response (Time Frame - Up to 3 Years 3 months): Duration of response is defined as time from achieving first response of CR, CRh, CRi or overall response to hematologic relapse or death of any cause.
10. Time to Response (Time Frame - Up to 3 Years 3 months): Time to response is defined as time from first dose to achieving the first response of CR, CRh, CRi or overall response.
Experimental: Arm A: Relapsed/Refractory Setting Participants with relapsed/refractory AML harboring either NPM1 or KMT2A alterations will receive JNJ-75276617 in combination with either venetoclax (VEN) (Cohort A1: JNJ75276617+VEN) or azacitidine (AZA) (Cohort A2: JNJ-75276617+AZA) or VEN+AZA (Cohort A3: JNJ-75276617+VEN+AZA) to select the recommended phase 2 dose (RP2D) of JNJ-75276617 in combination with VEN, AZA or VEN+AZA (dose selection). In dose expansion portion of the study, participants will receive JNJ-75276617 in combination with AML directed therapies at the RP2D(s).
Experimental: Arm B: Newly Diagnosed Chemotherapy Ineligible Setting Participants will receive JNJ-75276617 in combination with VEN+AZA as frontline chemo therapy for newly diagnosed AML participants harboring either KMT2A or NPM1 alterations who are greater than or equal to (>=)18 years of age to less than (<) 75 years of age with comorbidities that preclude the use of intensive induction chemotherapy.
Experimental: Arm C: Newly Diagnosed Chemotherapy Eligible Setting Participants will receive combination of JNJ-75276617 with cytarabine+daunorubicin or idarubicin chemotherapy as frontline treatment regimen for participants >=18 to <75 years of age with AML harboring either NPM1 or KMT2A alterations and eligible for intensive chemotherapy.