Lenalidomide and Dexamethasone for Rosai-Dorfman Disease

NCT ID: NCT04924647

Last Updated: 2021-06-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-08
• Study Completion Date: 2024-12-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

RD

lenalidomide and dexamethasone

Group Type: EXPERIMENTAL

lenalidomide and dexamethasone

Intervention Type: DRUG

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

Interventions

lenalidomide and dexamethasone

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Cao Xinxin

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dao-bin Zhou

Role: STUDY_CHAIR

Peking Union Medical College Hospital

Locations

Peking Union Medical College Hospital

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Xinxin Cao

Role: CONTACT

caoxinxin@pumch.cn

18618315968

Facility Contacts

Xinxin Cao

Role: primary

References

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.

Reference Type: DERIVED

PMID: 39022796 (View on PubMed)

Other Identifiers

PUMCHRDD1

Identifier Type: -

Identifier Source: org_study_id