Actively Recruiting

Phase 2
Age: 12Years +
All Genders
NCT06411821

Ulixertinib in People With Histiocytic Neoplasms

Led by Memorial Sloan Kettering Cancer Center · Updated on 2025-12-15

38

Participants Needed

8

Research Sites

155 weeks

Total Duration

On this page

Sponsors

M

Memorial Sloan Kettering Cancer Center

Lead Sponsor

B

BioMed Valley Discoveries, Inc

Collaborating Sponsor

AI-Summary

What this Trial Is About

The researchers are doing this study is to find out whether ulixertinib is an effective and safe treatment for people with histiocytic neoplasms.

CONDITIONS

Official Title

Ulixertinib in People With Histiocytic Neoplasms

Who Can Participate

Age: 12Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed histiocytic neoplasm or consistent histologic findings with radiologic or molecular confirmation
  • Identified mutation in MAPK pathway genes for primary cohort or no mutation needed for exploratory cohort
  • Measurable disease confirmed by radiologist
  • Age 18 years or older before interim analyses, or 12 years or older after interim analyses
  • Disease is recurrent, refractory, persistent, multisystem, or single-system causing organ dysfunction
  • Prior treatment with chemotherapy, immunosuppression, BRAF or MEK inhibitors with progressive or persistent disease, intolerance, or contraindication
  • ECOG performance status 0-2 (age 16+) or Lansky 50-100 (age 12-15)
  • Adequate renal function based on creatinine or clearance criteria
  • Adequate hepatic function within specified limits
  • Adequate bone marrow function with minimum blood counts
  • Adequate cardiac function with specific heart measurements
  • Appropriate contraception use or abstinence during and for 3 months after treatment
  • Willing and able to participate and comply with all trial requirements
  • Patients with prior or concurrent malignancy without interference to study may be included at investigator discretion
Not Eligible

You will not qualify if you...

  • Uncontrolled or severe medical conditions
  • Receipt of histiocytic neoplasm-directed therapy within 28 days before starting ulixertinib
  • Disease requiring observation-only or first-line local therapy per guidelines
  • Major surgery within 4 weeks before starting ulixertinib
  • Pregnant, lactating, or breast-feeding women
  • Serious active infections unless fever free for at least 48 hours
  • History or risk of retinal vein occlusion or central serous retinopathy
  • Concurrent use of strong inhibitors or inducers of specific liver enzymes
  • Concurrent use of certain drugs with narrow therapeutic indices
  • Inability to swallow oral medications
  • Prior stomach or duodenal resection affecting drug absorption or feeding tube use
  • Concurrent use of any investigational agents
  • Use of investigational drugs within 28 days or 5 half-lives before trial with unresolved toxicities

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 8 locations

1

Mayo Clinic (Data Collection Only)

Rochester, Minnesota, United States, 55905

Actively Recruiting

2

Memorial Sloan Kettering Basking Ridge (Consent Only)

Basking Ridge, New Jersey, United States, 07920

Actively Recruiting

3

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, United States, 07748

Actively Recruiting

4

Memorial Sloan Kettering Bergen (Consent Only)

Montvale, New Jersey, United States, 07645

Actively Recruiting

5

Memorial Sloan Kettering Suffolk-Commack (Consent Only)

Commack, New York, United States, 11725

Actively Recruiting

6

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, United States, 10604

Actively Recruiting

7

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States, 10065

Actively Recruiting

8

Memorial Sloan Kettering Nassau (Consent Only)

Uniondale, New York, United States, 11553

Actively Recruiting

Loading map...

Research Team

E

Eli Diamond, MD

CONTACT

R

Rona Yaeger, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here