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
Beijing, China
Location status: Recruiting
NCT Number: NCT07187167
In patients with Rosai-Dorfman disease (RDD), a treatment regimen of lenalidomide combined with dexamethasone is planned to be used.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Phase 2
Beijing, China
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: INNs
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.
Other names: INNs
Time frame: 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.
Time frame: 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) .
Time frame: From enrollment to the end of treatment at 8 weeks"
OS was measured from RD start to death or last follow-up
Time frame: 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.
Time frame: From enrollment to the end of treatment at 8 weeks"
Correlation between the positivity of NGS in MAPK pathway and therapeutic efficacy/PFS
Time frame: From enrollment to the end of treatment at 8 weeks
The score of Functional Assessment of Cancer Therapy - General
Contact information is provided by the study sponsor or research team.
Huilei HL Miao, doctor
CONTACT
Xinxin XX Cao, doctor
CONTACT
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Other
Efficacy and Safety of the RD Regimen (Lenalidomide, Dexamethasone) in the Treatment of Rosai-Dorfman Disease: A Prospective, Multicenter, Single-Arm Study.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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