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Two-Drug chemotherapy combo tested against rare histiocytosis in adults

NCT ID NCT02389400

NEW Disease control Sponsor: Peking Union Medical College Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 21, 2026 · Last updated Sep 21, 2026

Summary

Langerhans cell histiocytosis is a rare disease in which immune cells called Langerhans cells build up in organs and cause damage. This phase 2 trial gives adults newly diagnosed with the disease a combination of two chemotherapy drugs, methotrexate and cytosine arabinoside (cytarabine), to see whether the treatment controls the disease and how well participants tolerate it. Researchers track how long participants live without the disease getting worse and how long they live overall. The trial enrolls about 43 people and does not compare the combination against another treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a combination chemotherapy of methotrexate and cytosine arabinoside (cytarabine)
What this could lead to
If the combination works, it could offer adults with newly diagnosed Langerhans cell histiocytosis a way to control the disease and delay its return.
What could go wrong
This is a small, single-arm phase 2 trial with no comparison group, so any benefit is hard to separate from the natural course of the disease. Chemotherapy can cause side effects such as low blood counts, infections, and liver or kidney problems.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

43 people

The number who actually took part.

Start date

Jan 2014

Finished

Sep 2017

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 60 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1.DISEASE CHARACTERISTICS: * Histopathologically confirmed diagnosis of Langerhans cell histiocytosis according to the criteria defined by the Histiocyte Society * Demonstration of CD1a antigenic determinants on the surface of lesional cells (by immunocytology or immunohistology) or Birbeck granules in lesional cells by electron microscopy * Considered at risk or low risk according to the following criteria: * Multi-system at risk disease, defined as involvement of one or more risk organs (i.e., hematopoietic system, liver, spleen, or lungs) 1.No single-system lung involvement * Multi-system low-risk disease 1.Multiple organs involved but without involvement of risk organs * Single-system disease 1.Multifocal bone disease (i.e., lesions in 2 or more different bones) 2.Localized special site involvement, such as CNS-risk lesions with intracranial soft tissue extension or vertebral lesions with intraspinal soft tissue extension 3.Vault lesions are not regarded as CNS-risk lesions 2.PATIENT CHARACTERISTICS: 1. Not pregnant or nursing 2. Negative pregnancy test 3. Fertile patients must use effective contraception 3.PRIOR CONCURRENT THERAPY: <!-- --> 1. No prior treatment for Langerhans cell histiocytosis Exclusion Criteria:

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Conditions

The condition(s) this trial relates to.

Histiocytosis, Langerhans-Cell Langerhans cell histiocytosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Langerhans cell histiocytosis

Contacts and locations

Locations

  • Peking union medical college hospital

    Beijing, 100730, China

More trials for these conditions

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