Phase 3 Interstitial Lung Disease Trial, Recruiting NCT02670707 Sponsor: Baylor College of Medicine Condition: Interstitial Lung Disease
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Phase 3 Interstitial Lung Disease Trial, Recruiting

NCT02670707
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have been diagnosed with Langerhans cell histiocytosis (LCH) confirmed by a biopsy.
  • People who are between 0 and 21 years of age.
  • People who have a general health and functioning score of at least 50% on a standard medical scale used to measure daily activity ability.

Who may not be able to join:

  • People who have previously received systemic chemotherapy or similar drug treatments for LCH or any other cancer, with some exceptions: short courses of steroid medications (such as prednisone or dexamethasone) taken briefly before starting the trial do not affect eligibility, and people who have only had surgery, radiation therapy, steroid injections directly into a lesion, inhaled steroids, or steroid creams applied to the skin may still be considered eligible.
  • People whose disease is limited to only a single skin or bone site, unless that single site is in a location near the brain or spine that requires full-body treatment as standard care, or the single lesion is in a location where local treatment such as surgery would cause serious harm, or the person previously had LCH in at least one other location in the past (confirm with trial site for these exceptions).
  • People with severely reduced kidney function, based on specific blood and urine test results (confirm with trial site).
  • People with severely reduced liver function, based on specific blood test results, unless the liver problems are caused by LCH itself.
  • People who are currently pregnant or breastfeeding.
  • People who are able to have children but are not willing to use an adequate form of birth control for the entire duration of the study.
  • People who are HIV positive.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Olive Eckstein, MD, Baylor College of Medicine

Phone: 832-822-4242

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
7 March 2016
Est. completion
1 January 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Time to determine 1-year event-free survival (EFS) of patients treated with cytarabine monotherapy for LCH, compared directly with that of standard-of-care vinblastine/prednisone (Events include progression of LCH, relapse, or death).

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov