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NCT04079179 · ClinicalTrials.gov registry record · Phase 2

Cobimetinib in Refractory Langerhans Cell Histiocytosis (LCH), and Other Histiocytic Disorders

A Phase 2 study of Neuro-Degenerative Disease and Langerhans Cell Histiocytosis, sponsored by Carl Allen.

Recruiting
Registry status
Phase 2
Development phase
90
Enrollment target
12
Study locations

NCT04079179: Recruiting Phase 2 study of Neuro-Degenerative Disease and Langerhans Cell Histiocytosis, sponsored by Carl Allen.

NCT04079179 is a Phase 2 study of Neuro-Degenerative Disease and Langerhans Cell Histiocytosis that is actively recruiting participants, run by Carl Allen. The registered enrollment target is 90 participants, below the 734-participant average among 11 other Neuro-Degenerative Disease trials with a reported enrollment target (88% lower). The trial reports 12 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04079179, a Phase 2 study of Neuro-Degenerative Disease and Langerhans Cell Histiocytosis, is actively recruiting participants, sponsored by Carl Allen.

RECRUITING
Registry status
Phase 2
Development phase
90 participants
Enrollment target
12
Study locations

Study Summary

This is a research study of a drug called cobimetinib in children and adults diagnosed with Langerhans cell histiocytosis (LCH), and other histiocytic disorders that has returned or does not respond to treatment. Cobimetinib blocks activation of a protein called Mitogen-activated protein kinase (MEK) that is part of incorrect growth signals in histiocytosis cells. Four different groups of patients will be enrolled.

Primary Outcome

Proportion of participants with (complete response, partial response, stable disease, progressive disease) by 1 year of therapy with Cobimetinib. It is assumed that at each protocol-specified timepoint, a response assessment occurs. Status calculation will occur at each timepoint for patients who have measurable disease at baseline per the criteria defined in the protocol.

Conditions Studied

Neuro-Degenerative Disease Langerhans Cell Histiocytosis Erdheim-Chester Disease Rosai-Dorfman Disease Histiocytic Sarcoma Juvenile Xanthogranuloma Histiocytic Disorders, Malignant

Interventions

  • DRUG Cobimetinib

Study Locations (12)

California

  • Children's Hospital of Orange County - Orange
  • UCSF Benioff Children's Hospital - San Francisco

Texas

  • Children's Medical Center- UTSW - Dallas
  • Texas Children's Hospital - Houston

Arizona

  • Phoenix Children's Hospital - Phoenix

Arkansas

  • Arkansas Children's Hospital - Little Rock

District of Columbia

  • Children's National Hospital - Washington D.C.

Maryland

  • John Hopkins University School of Medicine - Baltimore

Massachusetts

  • Dana Farber Cancer Institute, Boston Children's - Boston

New York

  • Memorial Sloan Kettering Cancer Center - New York

Trial Details

FieldValue
Enrollment Target 90 participants
Start Date 2021-04-19
Est. Completion 2029-12
Phase Phase 2
Carl Allen

1 total trials

What NCT04079179 shows while recruiting

NCT04079179 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 734-participant average among 11 other Neuro-Degenerative Disease trials with a reported enrollment target (88% lower).

The record links to 7 conditions, with Neuro-Degenerative Disease appearing as the primary indexed condition, and to 1 intervention - of which Cobimetinib is the first listed.

NCT04079179 lists 12 locations in 10 states (California, Texas, Arizona).

Frequently Asked Questions

What is clinical trial NCT04079179 about?

NCT04079179 is a clinical study titled "Cobimetinib in Refractory Langerhans Cell Histiocytosis (LCH), and Other Histiocytic Disorders". This is a research study of a drug called cobimetinib in children and adults diagnosed with Langerhans cell histiocytosis (LCH), and other histiocytic disorders that has returned or does not respond to treatment. Cobimetinib blocks activation of a protein called Mitogen-activated protein kinase (MEK...

What is the current status of trial NCT04079179?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 90 participants. The study started on 2021-04-19. Estimated completion is 2029-12.

What conditions does trial NCT04079179 study?

This clinical trial studies the following conditions: Neuro-Degenerative Disease, Langerhans Cell Histiocytosis, Erdheim-Chester Disease, Rosai-Dorfman Disease, Histiocytic Sarcoma.

What interventions are being tested in trial NCT04079179?

The interventions under investigation include: Cobimetinib (DRUG).

Who is sponsoring clinical trial NCT04079179?

This trial is sponsored by Carl Allen, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04079179 being conducted?

This trial has 12 study locations across Arizona, Arkansas, California, District of Columbia, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Neuro-Degenerative Disease

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 NCT04079179's enrollment target sits among peer trials

90 6th of 11 higher than 5 of 11 other Neuro-Degenerative Disease trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Neuro-Degenerative Disease 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

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More recruiting context for NCT04079179

Source: ClinicalTrials.gov NCT04079179, the US trial registry maintained by the National Library of Medicine. NCT04079179 (small enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.