MedTrace Logo

A Study of JNJ-75276617 in Combination With Conventional Chemotherapy for Pediatric and Young Adult Participants With Relapsed/Refractory Acute Leukemias

NCT05521087 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2025-06-22

No results posted yet for this study

Summary

The purpose of this study is to determine the recommended Phase 2 dose(s) (RP2Ds) of JNJ-75276617 in combination with a conventional chemotherapy backbone in pediatric and young adult participants with relapsed/refractory 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 RP2D(s) of JNJ-75276617 in combination with chemotherapy in pediatric and young adult participants with relapsed/refractory acute leukemia harboring KMT2A1, NPM1, or nucleoporin alterations and safety at the RP2D(s) of JNJ-75276617 as monotherapy in a select low burden of disease cohort in Part 2 (Dose Expansion).

Conditions

Interventions

DRUG

JNJ-75276617

JNJ-75276617 will be administered orally.

DRUG

Fludarabine

Fludarabine chemotherapy will be administered as intravenous (IV) infusion for participants with AML.

DRUG

Cytarabine

Cytarabine chemotherapy will be administered as IV infusion for participants with AML.

DRUG

Intrathecal Chemotherapy

Intrathecal chemotherapy will be administered as IV infusion for participants with AML or B-cell ALL.

DRUG

Dexamethasone

Dexamethasone chemotherapy will be administered as IV infusion for participants with B-cell ALL.

DRUG

Vincristine

Vincristine chemotherapy will be administered as IV infusion for participants with B-cell ALL.

DRUG

Pegaspargase

Pegaspargase chemotherapy will be administered as IV infusion for participants with B-cell ALL.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
30 Days
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-26
Primary Completion
2026-09-11
Completion
2030-01-29
FDA Drug
Yes

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05521087 on ClinicalTrials.gov