Viewing Study NCT05453903



Ignite Creation Date: 2024-05-06 @ 5:50 PM
Last Modification Date: 2024-10-26 @ 2:36 PM
Study NCT ID: NCT05453903
Status: RECRUITING
Last Update Posted: 2024-05-23
First Post: 2022-07-08

Brief Title: A Study of Bleximenib in Combination With Acute Myeloid Leukemia AML Directed Therapies
Sponsor: Janssen Research Development LLC
Organization: Janssen Research Development LLC

Study Overview

Official Title: A Phase 1b Study of Bleximenib in Combination With AML-Directed Therapies for Participants With Acute Myeloid Leukemia Harboring KMT2A or NPM1 Alterations
Status: RECRUITING
Status Verified Date: 2024-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The purpose of this study is to determine the recommended Phase 2 dose RP2D candidates of bleximenib in combination with AML directed therapies dose selection and further to evaluate safety and tolerability of bleximenib in combination with AML directed therapies at the RP2Ds dose expansion
Detailed Description: AML is a heterogenous disease characterized by uncontrolled clonal expansion of hematopoietic progenitor cells myeloid blasts in the peripheral blood bone marrow and other tissues and is the most common type of acute leukemia in adults JNJ-75276617 is an orally bioavailable potent and selective protein-protein interaction inhibitor of the binding between histone-lysine N-methyltransferase 2A KMT2A also called mixed-lineage leukemia 1 MLL1 wild-type and fusion and menin with activity in leukemic cell lines and primary leukemia patient or patient-derived samples with either KMT2A alterations including gene rearrangements KMT2A-r duplications and amplification or nucleophosmin 1 gene NPM1 alterations The aim of this study is to determine the RP2Ds safety pharmacokinetic pharmacodynamic and preliminary clinical activity of JNJ-75276617 in combination with AML directed therapies for adult participants with relapsedrefractory or newly diagnosed AML with NPM1 or KMT2A gene alterations and will include dose selection and subsequent combination specific dose expansion The total study duration will be up to 2 years Safety evaluations include adverse events AE monitoring clinical laboratory tests electrocardiograms ECGs vital sign measurements physical examination findings and eastern cooperative oncology group ECOG performance status score

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: True
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
2023-506582-58-00 REGISTRY EUCT number None
2021-003999-14 EUDRACT_NUMBER None None
75276617ALE1002 OTHER None None