A Phase 1/2 Study of Bleximenib in Participants With Acute Leukemia (cAMeLot-1)

ClinicalTrials.gov ID: NCT04811560

Public ClinicalTrials.gov record NCT04811560. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

View official ClinicalTrials.gov record → Back to search

ClinicalTrials.gov public records Last synced Sep 6, 2026, 1:17 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 1/2, First-in-Human Study of the Menin-KMT2A (MLL1) Inhibitor Bleximenib in Participants With Acute Leukemia (cAMeLot-1)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of this study is to determine the recommended Phase 2 dose(s) (RP2D\[s\]) of bleximenib in phase 1 Part 1 (Dose Escalation) and to determine the safety and tolerability at RP2D in Phase 1 Part 2 (Dose expansion). The purpose of the Phase 2 part of the study is to evaluate the efficacy of bleximenib at the RP2D.

Study identification

NCT ID: NCT04811560
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 1, Phase 2
Lead sponsor: Janssen Research & Development, LLC; Industry
Enrollment: 420 participants

Conditions and interventions

Conditions

Acute Leukemia

Interventions

Bleximenib Drug

Drug

Eligibility (public fields only)

Age range: 2 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: May 18, 2021
Primary completion: Feb 25, 2027
Completion: Sep 21, 2030
Last update posted: Aug 27, 2026

2021 – 2030

United States locations

U.S. sites: 26
U.S. states: 16
U.S. cities: 23

Facility	City	State	ZIP	Site status
City of Hope	Duarte	California	91010	Recruiting
University of California Irvine Medical Center	Orange	California	92868	Completed
University of California San Francisco	San Francisco	California	94143	Recruiting
UCSF Benioff Children's Hospital	San Francisco	California	94158	Recruiting
University of Chicago	Chicago	Illinois	60637	Recruiting
St Francis Hospital & Health Centers Indiana Blood and Marrow Transplantation	Indianapolis	Indiana	46237	Recruiting
Norton Cancer Institute	Louisville	Kentucky	40207	Completed
Massachusetts General Hospital	Boston	Massachusetts	02114	Recruiting
Dana Farber Cancer Institute	Boston	Massachusetts	02115	Recruiting
Karmanos Cancer Institute	Detroit	Michigan	48201 2013	Completed
Start Midwest	Grand Rapids	Michigan	49546	Recruiting
University of New Mexico	Albuquerque	New Mexico	87131	Recruiting
Roswell Park Comprehensive Cancer Center	Buffalo	New York	14263	Recruiting
NYU Langone Medical Center	New York	New York	10016	Recruiting
Montefiore Medical Center	The Bronx	New York	10467	Recruiting
Oregon Health And Science University	Portland	Oregon	97239	Recruiting
Fox Chase Cancer Center	Philadelphia	Pennsylvania	19111	Completed
Maine Health	Providence	Rhode Island	02903	Recruiting
University of Tennessee Medical Center	Knoxville	Tennessee	37920	Recruiting
Baylor University Medical Center	Dallas	Texas	75246	Recruiting
Houston Methodist Hospital	Houston	Texas	77030-2740	Recruiting
MD Anderson	Houston	Texas	77030	Recruiting
San Antonio Methodist TX Transplant Physicians Group	San Antonio	Texas	78229	Recruiting
Virginia Commonwealth University	Richmond	Virginia	23298	Recruiting
Swedish Cancer Institute	Seattle	Washington	98104	Recruiting
Medical College of WI at Froedtert	Milwaukee	Wisconsin	53226	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 76 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT04811560, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Aug 27, 2026 · Synced Sep 6, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04811560 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →