Trials / Active Not Recruiting
Active Not RecruitingNCT05453903
A Study of Bleximenib in Combination With Acute Myeloid Leukemia (AML) Directed Therapies
A Phase 1b Study of Bleximenib in Combination With AML-Directed Therapies for Participants With Acute Myeloid Leukemia Harboring KMT2A or NPM1 Alterations
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 196 (actual)
- Sponsor
- Janssen Research & Development, LLC · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine the recommended Phase 2 dose (RP2D) candidate(s) 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 RP2D(s) (dose expansion).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Bleximenib | Participants will receive bleximenib. |
| DRUG | Venetoclax (VEN) | Participants will receive VEN. |
| DRUG | Azacitidine (AZA) | Participants will receive AZA. |
| DRUG | Cytarabine | Participants will receive cytarabine. |
| DRUG | Daunorubicin or Idarubicin | Participants will receive daunorubicin or idarubicin. |
Timeline
- Start date
- 2022-10-04
- Primary completion
- 2026-10-30
- Completion
- 2027-03-03
- First posted
- 2022-07-12
- Last updated
- 2026-04-13
Locations
32 sites across 8 countries: United States, Australia, Canada, France, Germany, Italy, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05453903. Inclusion in this directory is not an endorsement.