Recruiting NCT07187167
Efficacy and Safety of the RD Regimen(Lenalidomide, Dexamethasone) for Rosai-Dorfman Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lenalidomide, Dexamethasone.
- Who it may be relevant to
- Registry conditions: Rosai-Dorfman Disease. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy and Safety of the RD Regimen (Lenalidomide, Dexamethasone) in the Treatment of Rosai-Dorfman Disease: A Prospective, Multicenter, Single-Arm Study.
Overview
In patients with Rosai-Dorfman disease (RDD), a treatment regimen of lenalidomide combined with dexamethasone is planned to be used.
Detailed description
Patients received oral lenalidomide 25mg on days 1-21 and dexamethasone 40mg on days 1, 8, 15, 22, in 28-day cycles for 12 total cycles.
Interventions
- Drug Lenalidomide
The combination therapy period consists of 12 cycles: Lenalidomide: 25mg, orally, D1-21, every 28 days per cycle. Combined with Dexamethasone: 40mg, orally, D1, 8, 15, 22, every 28 days per cycle. The single-agent maintenance period consists of 12 cycles: Lenalidomide: 25mg, orally, D1-21, every 28 days per cycle. The total treatment duration is 24 cycles or until disease progression, death, or the occurrence of intolerable toxicity. - Drug Dexamethasone
The combination therapy period consists of 12 cycles: Lenalidomide: 25mg, orally, D1-21, every 28 days per cycle. Combined with Dexamethasone: 40mg, orally, D1, 8, 15, 22, every 28 days per cycle. The single-agent maintenance period consists of 12 cycles: Lenalidomide: 25mg, orally, D1-21, every 28 days per cycle. The total treatment duration is 24 cycles or until disease progression, death, or the occurrence of intolerable toxicity.
Primary outcome measures
- Progression-free survival time （PFS) [Time frame: From enrollment to the end of treatment at 8 weeks]
Secondary outcome measures (3)
- Overall Response Rate (ORR) [Time frame: From enrollment to the end of treatment at 8 weeks]
- Overall Survival (OS) [Time frame: From enrollment to the end of treatment at 8 weeks"]
- Adverse events [Time frame: From enrollment to the end of treatment at 8 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Department of Medical Oncology, National Cancer Center/National Clinical Research Center f — Beijing
Identifiers
NCT: NCT07187167 · NCCH005