Ignite Creation Date:
2024-05-06 @ 6:03 PM
Last Modification Date:
2024-10-26 @ 2:40 PM
Study NCT ID:
NCT05521087
Status:
WITHDRAWN
Last Update Posted:
2024-06-20
First Post:
2022-08-29
Brief Title:
A Study of JNJ-75276617 in Combination With Conventional Chemotherapy for Pediatric and Young Adult Participants With RelapsedRefractory Acute Leukemias
Sponsor:
Janssen Research Development LLC
Organization:
Janssen Research Development LLC
Study Overview
Official Title:
A Phase IIb Study of JNJ-75276617 in Combination With Conventional Chemotherapy for Pediatric and Young Adult Participants With RelapsedRefractory Acute Leukemias Harboring KMT2A NPM1 or Nucleoporin Gene Alterations
Status:
WITHDRAWN
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Business Decision
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 doses RP2Ds of JNJ-75276617 in combination with a conventional chemotherapy backbone in pediatric and young adult participants with relapsedrefractory acute leukemia harboring histone-lysine N-methyltransferase 2A1 KMT2A1 nucleophosmin 1 gene NPM1 or nucleoporin alterations in Part 1 Dose Escalation and to further evaluate safety at the RP2Ds of JNJ-75276617 in combination with chemotherapy in pediatric and young adult participants with relapsedrefractory acute leukemia harboring KMT2A1 NPM1 or nucleoporin alterations and safety at the RP2Ds of JNJ-75276617 as monotherapy in a select low burden of disease cohort in Part 2 Dose Expansion
Detailed Description:
None
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 |
|---|---|---|---|
| 75276617ALE1003 | OTHER | Janssen Research Development LLC | None |
| 2022-000380-46 | EUDRACT_NUMBER | None | None |