Summary

Eligibility
for people ages 12 years and up (full criteria)
Location
at UC Irvine UCSF
Dates
study started
completion around
Principal Investigator
by Neil Dunavin (ucsf)
Headshot of Neil Dunavin
Neil Dunavin

Description

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.

Official Title

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

Keywords

Acute Leukemias, Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Leukemia, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Acute Disease, Bleximenib

Eligibility

Locations

  • University of California Irvine Medical Center completed
    Orange California 92868 United States
  • University of California San Francisco accepting new patients
    San Francisco California 94143 United States
  • City of Hope accepting new patients
    Duarte California 91010 United States

Lead Scientist at University of California Health

  • Neil Dunavin (ucsf)
    Hematologist with interests in leukemia, stem cell transplantation, myelodysplastic syndrome, myeloproliferative neoplasms, aplastic anemia, bone marrow failure, rare diseases, and clinical trials.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Janssen Research & Development, LLC
ID
NCT04811560
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
Expecting 400 study participants
Last Updated