Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04811560 · ClinicalTrials.gov registry record · Phase 1
A Phase 1/2 Study of Bleximenib in Participants With Acute Leukemia (cAMeLot-1)
A Phase 1 study of Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia, sponsored by Janssen Research & Development.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 400
- Enrollment target
- 20
- Study locations
NCT04811560: Recruiting Phase 1 study of Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia, sponsored by Janssen Research & Development.
NCT04811560 is a Phase 1 study of Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia that is actively recruiting participants, run by Janssen Research & Development. The registered enrollment target is 400 participants, above the 115-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (248% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04811560, a Phase 1 study of Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia, is actively recruiting participants, sponsored by Janssen Research & Development.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 400 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Conditions Studied
Interventions
- DRUG Bleximenib
Study Locations (20)
California
- City of Hope - Duarte
- University of California Irvine Medical Center - Orange
- University of California San Francisco - San Francisco
- UCSF Benioff Children's Hospital - San Francisco
New York
- Roswell Park Comprehensive Cancer Center - Buffalo
- NYU Langone Medical Center - New York
- Montefiore Medical Center - The Bronx
Massachusetts
- Massachusetts General Hospital - Boston
- Dana Farber Cancer Institute - Boston
Michigan
- Karmanos Cancer Institute - Detroit
- Start Midwest - Grand Rapids
Arizona
- City of Hope Phoenix - Goodyear
Illinois
- University of Chicago - Chicago
Indiana
- St Francis Hospital & Health Centers Indiana Blood and Marrow Transplantation - Indianapolis
Kentucky
- Norton Cancer Institute - Louisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2021-05-19 |
| Est. Completion | 2028-05-26 |
| Phase | Phase 1 |
What NCT04811560 shows while recruiting
NCT04811560 is an interventional study that assigns participants to a tested intervention. The registered 400 participants enrollment target is mid-sized for trials with a published cap, above the 115-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (248% higher).
The record links to 3 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 1 intervention - of which Bleximenib is the first listed.
NCT04811560 names 20 study sites across 13 states, led by California, New York, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04811560 about?
NCT04811560 is a clinical study titled "A Phase 1/2 Study of Bleximenib in Participants With Acute Leukemia (cAMeLot-1)". 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...
What is the current status of trial NCT04811560?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 400 participants. The study started on 2021-05-19. Estimated completion is 2028-05-26.
What conditions does trial NCT04811560 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Acute Leukemias.
What interventions are being tested in trial NCT04811560?
The interventions under investigation include: Bleximenib (DRUG).
Who is sponsoring clinical trial NCT04811560?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04811560 being conducted?
This trial has 20 study locations across Arizona, California, Illinois, Indiana, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Acute Myeloid Leukemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04811560's enrollment target sits among peer trials
400 14th of 306 higher than 292 of 306 other Acute Myeloid Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Myeloid Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Study to Assess the Safety, Tolerability, and Antileukemic Activity of Debio 1562M in Participants With Acute Myeloid Leukemia (AML)
RECRUITING · Phase 1
-
A Study of CD371-YSNVZIL-18 CAR T Cells in People With Acute Myeloid Leukemia
RECRUITING · Phase 1
-
CPX-351 in Combination With Gemtuzumab Ozogamicin in Newly Diagnosed AML
RECRUITING · Phase 1
-
FHD-286 With Low-Dose Weekly Decitabine/Venetoclax in Patients With Acute Myeloid Leukemia
RECRUITING · Phase 1
-
Testing the Combination of an Anti-Cancer Drug, Iadademstat, With Other Anti-Cancer Drugs (Venetoclax and Azacitidine) for Treating AML
RECRUITING · Phase 1
-
The Pediatric Acute Leukemia (PedAL) Screening Trial - A Study to Test Bone Marrow and Blood in Children With Leukemia That Has Come Back After Treatment or Is Difficult to Treat - A Leukemia & Lymphoma Society and Children's Oncology Group Study
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01665326 · 400 participants
Determination of CRIM Status and Longitudinal Follow-up of Individuals With Pompe Disease
- NCT02108054 · 400 participants · NA
Behavioral and Functional Task Development, Implementation, and Testing
- NCT02216500 · 400 participants · NA
Ketogenic Therapy Effects on Electrical and Metabolic Abnormalities in Epilepsy
- NCT02250352 · 400 participants
Core Biopsies for Establishing a Breast Tumor Tissue Repository
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI