Trials / Withdrawn
WithdrawnNCT05521087
A Study of JNJ-75276617 in Combination With Conventional Chemotherapy for Pediatric and Young Adult Participants With Relapsed/Refractory Acute Leukemias
A Phase I/Ib Study of JNJ-75276617 in Combination With Conventional Chemotherapy for Pediatric and Young Adult Participants With Relapsed/Refractory Acute Leukemias Harboring KMT2A, NPM1, or Nucleoporin Gene Alterations
- Status
- Withdrawn
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Janssen Research & Development, LLC · Industry
- Sex
- All
- Age
- 30 Days – 30 Years
- Healthy volunteers
- Not accepted
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
- Acute Leukemias
- Acute Myeloid Leukemia
- Acute Lymphoblastic Leukemia
- Acute Leukemia of Ambiguous Lineage
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2025-12-26
- Primary completion
- 2026-09-11
- Completion
- 2030-01-29
- First posted
- 2022-08-30
- Last updated
- 2025-06-22
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05521087. Inclusion in this directory is not an endorsement.