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Tests treatment safety and results for Rosai-Dorfman Disease
Official title Efficacy and Safety of the RD Regimen(Lenalidomide, Dexamethasone) for Rosai-Dorfman Disease
ClinicalTrials.gov ID: NCT07187167
What this study is testing
What is Lenalidomide?
Lenalidomide is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for rosai-dorfman disease.
Also referred to as INNs.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- In patients with Rosai-Dorfman disease (RDD), a treatment regimen of lenalidomide combined with dexamethasone is planned to be used.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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;
You likely can't join if
- people who have undergone major surgery within 4 weeks prior to the first dose of the study;
- people who have received radiotherapy within 4 weeks prior to the first dose of the study;
- people 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;
See the full eligibility 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.
- people who have undergone major surgery within 4 weeks prior to the first dose of the study;
- people who have received radiotherapy within 4 weeks prior to the first dose of the study;
- people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.