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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 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.

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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.

Conditions Studied

Acute Myeloid Leukemia Acute Lymphoblastic Leukemia Acute Leukemias

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

FieldValue
Enrollment Target 400 participants
Start Date 2021-05-19
Est. Completion 2028-05-26
Phase Phase 1

Sponsor

Janssen Research & Development

593 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04811560

The ClinicalTrials.gov registry entry for NCT04811560 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 400 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 115-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (248% higher). The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 13 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.