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A Phase 1/2 Study of Bleximenib in Participants With Acute Leukemia (cAMeLot-1) | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

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

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

NCT04811560•Janssen Research & Development, LLC

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

2 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Phase 1:
•Age 2 years and above (pediatric cohort only), all other cohorts 18 years and above
•Relapsed or refractory (R/R) acute leukemia and has exhausted, or is ineligible for, available therapeutic options
•Acute leukemia harboring histone-lysine N-methyltransferase 2A (KMT2A), nucleophosmin 1 gene (NPM1) or nucleoporin 98 gene or nucleoporin 214 gene (NUP98 or NUP214) alterations
•Phase: 2
•Participants greater than 18 years are eligible
•Must have had an initial diagnosis of acute myeloid leukemia (AML) per the WHO 2022 classification criteria and have relapsed/refractory disease
•AML harboring KMT2A-r (gene rearrangement/translocation) or NPM1 mutations only
•For Both Phase 1 and 2:
•Pretreatment clinical laboratory values meeting the following criteria: (a) Hematology: white blood cell (WBC) count less than or equal to (\<=) 20\*10\^9/liter (L) and (b) renal function; For adult participants, estimated or measured glomerular filtration rate greater than equal (\>=) 30 milliliter per minute (mL/min) per four variable MDRD equation. For pediatric participants an estimated or measured glomerular filtration rate \>50 mL/min per the CKiD (Chronic Kidney Disease in Children) Schwartz formula
+3 more criteria

Exclusion Criteria

•Acute promyelocytic leukemia, diagnosis of Down syndrome associated leukemia or juvenile myelomonocytic leukemia according to World Health Organization (WHO) 2016 criteria
•Active central nervous system (CNS) disease
•Prior solid organ transplantation
•QTc according to Fridericia's formula (QTcF) for males \>= 450 millisecond (msec) or for females \>= 470 msec. Participants with a family history of Long QT syndrome are excluded
•Prior cancer immunotherapy within 4 weeks prior to enrollment or blinatumomab within 2 weeks prior to enrollment. Additional prior cancer therapies must not be given within 4 weeks prior to enrollment or 5 half-lives of the agent (whichever is shorter)

Locations (101)

City of Hope Phoenix

Goodyear, Arizona, United States

City of Hope

Duarte, California, United States

University of California Irvine Medical Center

Orange, California, United States

University of California San Francisco

San Francisco, California, United States

UCSF Benioff Children's Hospital

San Francisco, California, United States

University of Chicago

Chicago, Illinois, United States

St Francis Hospital & Health Centers Indiana Blood and Marrow Transplantation

Indianapolis, Indiana, United States

Norton Cancer Institute

Louisville, Kentucky, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Key Dates

Start Date

May 19, 2021

Primary Completion Date

February 16, 2026

Completion Date

May 26, 2028

Last Updated

January 16, 2026

Enrollment

400

ESTIMATED participants

Conditions

Acute LeukemiasAcute Myeloid LeukemiaAcute Lymphoblastic Leukemia

Interventions

Bleximenib

DRUG

Contacts

Study Contact

CONTACT

844-434-4210 Participate-In-This-Study1@its.jnj.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 16, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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