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In patients with Rosai-Dorfman disease (RDD), a treatment regimen of lenalidomide combined with dexamethasone is planned to be used.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with RDD | Experimental | Patients with RDD who are treatment-naive or have not previously received lenalidomide; aged 18-80 years; ECOG PS 0-2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lenalidomide | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival time (PFS) | PFS defined as the time from RD initiation to first documented disease progression, relapse after RD, death from any cause, or last follow-up. | From enrollment to the end of treatment at 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | The overall response rate (ORR) was defined as the cumulative proportion of patients attaining either a complete response (CR) or partial response (PR) . | From enrollment to the end of treatment at 8 weeks |
| Overall Survival (OS) |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between next-generation sequence (NGS) and therapeutic efficacy/PFS | Correlation between the positivity of NGS in MAPK pathway and therapeutic efficacy/PFS | From enrollment to the end of treatment at 8 weeks" |
| Fact-G |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xinxin XX Cao, doctor | Contact | 18618315968 | caoxinxin@126.com | |
| Huilei HL Miao, doctor | Contact | +86-18801317695 | miaohl13@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xinxin XX Cao, doctor | NCC, CICAMS | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 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 |
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| ID | Term |
|---|---|
| D015618 | Histiocytosis, Sinus |
| ID | Term |
|---|---|
| D015616 | Histiocytosis, Non-Langerhans-Cell |
| D015614 | Histiocytosis |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D000077269 | Lenalidomide |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
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A multicenter, prospective, interventional study, with a planned number of subjects: approximately 40 cases.
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|
|
| Dexamethasone | Drug | 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. |
|
|
OS was measured from RD start to death or last follow-up |
| From enrollment to the end of treatment at 8 weeks" |
| Adverse events | Toxicities were recorded and graded per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. | From enrollment to the end of treatment at 8 weeks |
The score of Functional Assessment of Cancer Therapy - General
| From enrollment to the end of treatment at 8 weeks |
|
| D009930 |
| Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |