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New drug combo aims to tame rare histiocytosis in adults

NCT ID NCT07187193

Disease control Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This phase 2 trial is testing a combination of low-dose cytarabine (a chemotherapy drug) and thalidomide in 50 adults with untreated Langerhans cell histiocytosis (LCH), a rare disease where immune cells build up and damage tissues. Participants receive up to 24 cycles of treatment over about two years. The goal is to see if this combo can control the disease and improve survival, with fewer side effects than standard treatments.

What this could mean

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

Active substance
cytarabine and thalidomide
What this could lead to
If successful, this combination could offer a new treatment option for adults with Langerhans cell histiocytosis, potentially controlling the disease and improving survival.
What could go wrong
This is a small, early-phase trial with no control group, so results may not be definitive. Side effects from chemotherapy and thalidomide are possible, and the treatment may not work for everyone.

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

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Apr 2027

An estimate. End dates often move.

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 70 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: * Clearly diagnose and treat adult patients with multisystem or single-system multifocal LCH; * Aged between 18 and 70 years; * Multisystem involvement or single-system multifocal disease; * No prior systemic treatment (patients who have only received local radiotherapy or surgery may be enrolled); * ECOG performance status score ≤ 2; * Judged by clinicians as suitable for treatment with this protocol; * Patients or their families able to understand the study protocol and willing to participate in the study, providing written informed consent. Exclusion Criteria: * Patients with LCH involving the central nervous system; * Single-system single-lesion LCH; * Subjects who have undergone major surgery within 4 weeks prior to the first dose in the study; * Subjects who have received radiotherapy within 4 weeks prior to the first dose in the study; subjects with a history of myocardial infarction within the past year; * Patients with New York Heart Association (NYHA) class 3 or 4 congestive heart failure, or a history of NYHA class 3 or 4 congestive heart failure; * Pregnant or lactating women; * Abnormal liver and kidney function: creatinine level ≥176.8μmol/l (2mg/dl), transaminase and bilirubin levels more than 2 times the upper limit of normal (for LCH patients with liver involvement, bilirubin levels more than 10 times the upper limit of normal); * Abnormal blood counts: absolute neutrophil count less than 1×10\^9/L, platelet count less than 50×10\^9/L; * Patients or their families unable to understand the conditions and objectives of this study; * Any other circumstances in which the investigator deems the patient unsuitable to participate in this trial.

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

    RECRUITING

    Beijing, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.