Rosai-Dorfman Disease
Conditions
Brief summary
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
DRUGLenalidomide
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.
DRUGDexamethasone
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.
Sponsors
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A multicenter, prospective, interventional study, with a planned number of subjects: approximately 40 cases.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival time （PFS) | From enrollment to the end of treatment at 8 weeks | PFS defined as the time from RD initiation to first documented disease progression, relapse after RD, death from any cause, or last follow-up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate (ORR) | From enrollment to the end of treatment at 8 weeks | The overall response rate (ORR) was defined as the cumulative proportion of patients attaining either a complete response (CR) or partial response (PR) . |
| Overall Survival (OS) | From enrollment to the end of treatment at 8 weeks | OS was measured from RD start to death or last follow-up |
| Adverse events | From enrollment to the end of treatment at 8 weeks | Toxicities were recorded and graded per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Correlation between next-generation sequence (NGS) and therapeutic efficacy/PFS | From enrollment to the end of treatment at 8 weeks | Correlation between the positivity of NGS in MAPK pathway and therapeutic efficacy/PFS |
| Fact-G | From enrollment to the end of treatment at 8 weeks | The score of Functional Assessment of Cancer Therapy - General |
Countries
China
Contacts
Primary ContactXinxin XX Cao, doctor
Backup ContactHuilei HL Miao, doctor
Outcome results
None listed