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New drug combo aims to tame rare inflammatory disease

NCT ID NCT07187167

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether a combination of lenalidomide and dexamethasone can control Rosai-Dorfman disease, a rare condition causing swollen lymph nodes and tissue inflammation. About 40 adults who are newly diagnosed or have not responded to prior treatments will receive up to 24 cycles of therapy. The main goal is to see how long the disease stays under control.

What this could mean

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

Active substance
lenalidomide and dexamethasone
What this could lead to
If successful, this could provide a new treatment option to control Rosai-Dorfman disease and improve progression-free survival.
What could go wrong
This is a small, early-phase trial with only 40 participants and no comparison group. The drugs have known side effects, and results may not apply to all patients.

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 40 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 80 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: * Definitively diagnosed adult RDD patients; * Aged between 18 and 80 years; * Treatment-naive or refractory/relapsed; * 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: * Subjects who have undergone major surgery within 4 weeks prior to the first dose of the study; * Subjects who have received radiotherapy within 4 weeks prior to the first dose of 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; * Patients who cannot strictly practice contraception after participating in the study; * Abnormal liver and kidney function: creatinine level ≥176.8 μmol/L (2 mg/dL), transaminase and bilirubin levels more than 2 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 who cannot understand the conditions and objectives of the study; * Any other situation where the investigator considers the patient unsuitable to participate in this trial.

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Conditions

The condition(s) this trial relates to.

sinus histiocytosis with massive lymphadenopathy

As listed by the trial registrant

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

Rosai dorfman disease

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.