Fort Worth, TXNCT06582745Now EnrollingIRB Ready

Langerhans Cell Histiocytosis Clinical Trial in Fort Worth, TX

Access cutting-edge langerhans cell histiocytosis treatment through this clinical trial at a research site in Fort Worth. Study-provided care at no cost to qualified participants.

Sponsored by Cook Children's Health Care System

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Expert Care in Fort Worth

Access langerhans cell histiocytosis specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related langerhans cell histiocytosis treatment provided free

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Check if you qualify for this langerhans cell histiocytosis clinical trial in Fort Worth, TX

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Why Participate?

  • No-Cost Study Care

  • Local to Fort Worth

    Convenient for TX residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Fort Worth site if eligible
  4. 4Begin participation

About This Langerhans Cell Histiocytosis Study in Fort Worth

The purpose of this Phase II clinical trial is to establish the safety and effectiveness of trametinib, a targeted therapy, for the treatment of newly or recently diagnosed Langerhans Cell Histiocytosis (LCH) among pediatric patients.

Sponsor: Cook Children's Health Care System

Who Can Participate

Inclusion Criteria

Diagnosis/disease status:
Patients with newly diagnosed Langerhans cell histiocytosis (LCH) OR
Patients with relapsed or refractory disease OR
Patients with newly diagnosed or relapsed/refractory disease who are receiving the liquid formula of trametinib OR
Patients who have been receiving trametinib as a treatment for LCH since January 1, 2020 may be included in the observational chart review to track long-term follow-up. Eligibility for chart review cohort will include receiving trametinib as treatment.
Diagnosis confirmed with biopsy prior to start of treatment
Patient must have adequate cardiac function evident through Echocardiogram (ECHO) and Electrocardiogram (EKG) within 30 days of starting treatment.
Shortening fraction of ≥ 27% by echocardiogram or
Ejection fraction of ≥ 50% by gated radionuclide study
QTC \< 480 msec
Performance status: Patients must have a performance status corresponding to ECOG scores of 0, 1, or 2. Use Karnofsky ≥ 50% for patients \> 16 years of age and Lansky ≥50% for patients ≤16 years of age.
Adequate organ and marrow function as defined below:
Absolute Neutrophil count ≥ 1,500/μL
Platelets ≥ 100x103/μL
Total bilirubin ≤ 1.5X ULN for age
AST/ALT ≤ 2.5 X ULN for age
Serum creatinine based on age/gender
Hemoglobin ≥ 8 g/dL
Patients with bone marrow disease must have hemoglobin ≥ 8 g/dL with transfusion support allowed
Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 4 months after the last dose. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Ability to understand study procedures and to comply with them for the entire length of the study.

Exclusion Criteria

Patients diagnosed with Low-Risk True Skin Only or a Single Bone lesion that does not require treatment and will only be observed will not be eligible, with the exception of CNS-risk lesions/special site disease or functionally critical lesions:
CNS-risk/special site includes: Sphenoid, Mastoid, Orbital, zygomatic, ethmoid, maxillary, or temporal bones, the cranial fossa, pituitary gland or neurodegenerative disease, odontoid peg, vertebral lesion with intraspinal soft tissue extension
Functionally critical: A single lesion not described above which may cause "functionally critical anatomic abnormality" wherein attempts at local therapy would cause unacceptable morbidity. This can be at the discretion of the Principal Investigator.
Patients whose genetic testing reveals a class 3 MAP2K1 mutation:
I103\_K104del
E102\_I103del
L98\_K104delinsQ
L98\_I103del
I99\_K104del
Patients who present with jaundice at diagnosis.
Patients who are pregnant or breastfeeding are not eligible. Women of childbearing potential must receive a negative pregnancy test within 14 days of starting treatment or the patient will not be eligible.
Patients who are allergic to trametinib
Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
Inability or unwillingness of patient or parent/legally authorized representative to give written informed consent.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Fort Worth?

Yes, this clinical trial (NCT06582745) has an active research site in Fort Worth, TX that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Langerhans Cell Histiocytosis Treatment Options in Fort Worth, TX

If you're searching for langerhans cell histiocytosis treatment options in Fort Worth, TX, this clinical trial (NCT06582745) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Fort Worth research site is actively enrolling participants for this clinical trial. You'll receive care from experienced langerhans cell histiocytosis specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

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