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Comparing Vinblastine/Prednisone to Cytarabine for Langerhans Cell Histiocytosis

This study is comparing two chemotherapy treatments for Langerhans Cell Histiocytosis (LCH), a type of cancer that can damage body tissues. The study aims to see if cytarabine, a drug often used for LCH that has returned, is as effective as the standard treatment, which is a combination of vinblastine and prednisone. You could join if you are between 0 and 21 years old, have LCH confirmed by a biopsy, and your LCH cannot be treated by surgery alone. The main goal is to measure how many patients are free from LCH progression, relapse, or death one year after starting treatment. The study is currently recruiting 124 participants, but its overall status is unclear.

Study design
This is an interventional study where participants will be randomly assigned (like flipping a coin) to receive either vinblastine/prednisone or cytarabine. Neither you nor your doctor can choose which treatment you receive, but you will both know which one it is.
What's involved
You will undergo tests, exams, or procedures, many of which are part of regular cancer care. Some may not need to be repeated if done recently, and your doctor will advise which ones are necessary.
Compensation
Not stated in the trial record.
Follow-up
Your event-free survival will be measured for up to 60 months (5 years) after treatment.

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NCT02670707

Vinblastine/Prednisone Versus Single Therapy With Cytarabine for Langerhans Cell Histiocytosis (LCH)

Recruiting
PHASE3Up to 21InterventionalTreatment
Baylor College of Medicine
~124 participants
Updated 2025-09-11 on ClinicalTrials.gov
What's tested:CytarabineVinblastine/prednisone

At a glance

Recruiting sites
10 of 11 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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).
Measured over up to 60 months

Conditions

Langerhans Cell Histiocytosis

Explore related trials

Langerhans Cell Histiocytosis

NCT02670707

Where you'd take part

This study runs at 11 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Children's Hospital of San Antonio

    San Antonio, Texasstudy coordinator listed

    Recruiting

  • Children's Hospital of The King's Daughters

    Norfolk, Virginiastudy coordinator listed

    Recruiting

  • Cook Children's Health Care System

    Fort Worth, Texasstudy coordinator listed

    Recruiting

  • Dell Children's Medical Center

    Austin, Texasstudy coordinator listed

    Recruiting

  • Lehigh Valley Health Network- Cedar Crest

    Allentown, Pennsylvaniastudy coordinator listed

    Recruiting

  • Nationwide Children's Hospital

    Columbus, Ohiostudy coordinator listed

    Recruiting

  • Rady Children's Hospital - San Diego

    San Diego, Californiastudy coordinator listed

    Recruiting

  • Stanford Children's Hospital, Lucile Packard Children's Hospital

    Palo Alto, Californiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Olive Eckstein, MD · STUDY_CHAIR · Baylor College of Medicine

Who to contact

Olive Eckstein, MD
[email protected]
832-822-4242
Email the study team

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Eligibility criteria

Exclusion

Central Nervous System (CNS) risk lesions/special site disease: patients with single bone sites that are CNS-risk (sphenoid, mastoid, orbital, zygomatic, ethmoid, maxillary, or temporal bones, the cranial fossa, pituitary gland or neurodegenerative disease) or are "special sites" (odontoid peg, vertebral lesion with intraspinal soft tissue extension) require systemic therapy as standard of care and thus are eligible for the study.
Functionally critical lesions: A single lesion not described above which may cause "functionally critical anatomic abnormality" wherein attempts at local therapy (such as surgical curettage or radiation) would cause unacceptable morbidity. These patients may be enrolled with written approval of the Coordinating Center PI or Vice-Chair and documentation of the rationale justifying systemic therapy.
Asynchronous multisite LCH presentation: A patient may also have any single site of disease involvement at the time of enrollment if they previously had at least one other site of LCH disease in the past (which may have been treated with local therapy/surgery as described), as long as no systemic therapy was previously given per protocol guidelines. 3. Patient may not have severe renal disease (creatinine greater than 3 times normal for age OR creatinine clearance \< 50 ml/m2/1.73m\^2). 4. Patient may not have severe hepatic disease (direct bilirubin greater than 3 mg/dl OR aspartate aminotransferase (AST) greater than 500 IU/L), unless hepatic injury is due to LCH. 5. Female patients may not be pregnant or breastfeeding. 6. Patients of reproductive potential not willing to use an adequate method of birth control for the duration of the study. 7. Patients who are HIV positive may not be enrolled.

What this trial measures

  • 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).up to 60 months

    A Kaplan-Meier curve will be used to compare event-free survival between treatment groups. Curves will be compared using the log-rank statistic. Patients will be followed for up to 5 years after one year of therapy. Patients who have not had the event by the 5-year mark will be censored observations. Patients who are lost to follow-up without having an event will be censored at the time of last contact. Statistical significance will be assessed at the 0.05 level. A Cox proportional hazards model will also be used to estimate the Hazards Rate for combined events in the Cytarabine group versus standard therapy. A multiple regression model will also be used to estimate the adjusted HRs for genotype and baseline risk of death (high vs. low).