Lenalidomide and Dexamethasone for Rosai-Dorfman Disease

NCT04924647 | Unknown Phase 2

• 1 other identifier: PUMCHRDD1
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Rosai-Dorfman Disease (RDD) is a rare, heterogeneous histiocytic disorder. Because of the rarity of RDD and a lack of prospective randomized trials, the treatment strategy for RDD is mostly based on retrospective study. Steroid was suggested as frontline treatment as RDD with only lymph nodes involvement. Studies showed thalidomide or lenalidomide showed some effect in recurrent/refractory skin RDD. The investigators want to analyze the efficacy and toxicity of lenalidomide combined with dexamethasone regimens in the treatment of RDD among adult patients at our hospital.

Conditions

Rosai-Dorfman Disease

Keywords

Rosai-Dorfman Disease; lenalidomide; dexamethasone

Outcome Measures

Primary Outcomes (1)

• Event-free survival

  Events were defined as a poor response to RD, reactivation after RD therapy and death from any cause.

  the duration from initiation of treatment to the date of first documented event or date of death from any cause, whichever come first, assessed up to 5 years

Secondary Outcomes (2)

• Overall response rate

  on 12 months

• Overall survival

  the duration from initiation of RD treatment to the date of death or last follow-up, assessed up to 5 years

Study Arms (1)

RD

EXPERIMENTAL

lenalidomide and dexamethasone

Drug: lenalidomide and dexamethasone

Interventions

lenalidomide and dexamethasone DRUG

lenalidomide 25mg d1-21 and dexamethasone 20-40mg d1，8，15，22

RD

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed diagnosis of RDD
• Age ≥18 years
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
• Patients must have adequate renal, liver, and bone marrow function as defined by the following criteria:
• Absolute neutrophil count ≥1500 cells per mm3 Platelet count ≥100000 cells per mm3 Creatinine clearance \[according to Cockcroft formula\] ≥60 mL/min. Aspartate aminotransferase and alanine aminotransferase ≤2·5×upper limit of normal \[ULN\], and total bilirubin ≤2·5×ULN; or ≤10×ULN in the case of known liver involvement by RDD.
• No active or untreated infection.
• No cardiac abnormalities.
• Subject provide written informed consent.
• A female is eligible to enter and participate in this study if she is of:
• Non-childbearing potential including ω Any female who has had a surgical procedure rendering her incapable of becoming pregnant.
• ω Subjects have experienced total cessation of menses for more than 1 year and be greater than 45 years in age.
• ⎫ Childbearing potential, including any female who has had a negative serum pregnancy test within 2 weeks prior to the first dose of study treatment, and agrees to use adequate contraception.
• Male subjects must use an effective barrier method of contraception during the study and for 90 days following the last course of MA if sexually active with a childbearing potential

You may not qualify if:

• Patients had concurrent malignancies.
• History of myocardial infarction, or unstable angina, or New York Heart Association (NYHA) Grade III-IV within 6 months prior to Day 1.
• Women who were pregnant or of childbearing potential.
• Known HIV seropositive, active hepatitis C infection, and/or hepatitis B (defined as HCV RNA≥1000 copies or HBV DNA ≥1000 copies at screening).
• Major surgical procedure within 28 days prior to the first dose of study treatment.
• Presence of uncontrolled infection.
• Evidence of active bleeding or bleeding diathesis.
• Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

RECRUITING

Related Publications (1)

• Chang L, Lang M, Liu T, Lin H, Liu ZZ, Cai H, Zhou DB, Cao XX. Lenalidomide and dexamethasone for Rosai-Dorfman disease: a single arm, single center, prospective phase 2 study. EClinicalMedicine. 2024 Jun 21;73:102685. doi: 10.1016/j.eclinm.2024.102685. eCollection 2024 Jul.

  PMID: 39022796 DERIVED

MeSH Terms

Conditions

Histiocytosis, Sinus

Interventions

Lenalidomide; Dexamethasone

Condition Hierarchy (Ancestors)

Histiocytosis, Non-Langerhans-Cell; Histiocytosis; Lymphatic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Dao-bin Zhou

  Peking Union Medical College Hospital

  STUDY CHAIR

Central Study Contacts

Xinxin Cao

CONTACT

18618315968; caoxinxin@pumch.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 7, 2021
• First Posted: June 14, 2021
• Study Start: June 8, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: June 16, 2021

Record last verified: 2021-06

Locations

CN (1)