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Lenalidomide and Dexamethasone for Rosai-Dorfman Disease

Primary Purpose

Rosai-Dorfman Disease

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

lenalidomide and dexamethasone

About this trial

This is an interventional treatment trial for Rosai-Dorfman Disease focused on measuring Rosai-Dorfman Disease, lenalidomide, dexamethasone

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Peking Union Medical College HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

lenalidomide and dexamethasone

Outcomes

Primary Outcome Measures

Event-free survival

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

Secondary Outcome Measures

Overall response rate

the cumulative number of patients with either non-active disease or regressive disease (signs and symptoms were improved with no new lesions) after RD

Overall survival

Full Information

NCT ID

NCT04924647

First Posted

June 7, 2021

Last Updated

June 11, 2021

Sponsor

Peking Union Medical College Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04924647

Brief Title

Lenalidomide and Dexamethasone for Rosai-Dorfman Disease

Official Title

Lenalidomide and Dexamethasone for Rosai-Dorfman Disease: A Single Arm, Single Center, Prospective Phase 2 Study

Study Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Recruiting

Study Start Date

June 8, 2021 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Peking Union Medical College Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rosai-Dorfman Disease

Keywords

Rosai-Dorfman Disease, lenalidomide, dexamethasone

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

lenalidomide and dexamethasone

Intervention Type

Drug

Intervention Name(s)

lenalidomide and dexamethasone

Intervention Description

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

Primary Outcome Measure Information:

Title

Event-free survival

Description

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

Time Frame

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 Outcome Measure Information:

Title

Overall response rate

Description

the cumulative number of patients with either non-active disease or regressive disease (signs and symptoms were improved with no new lesions) after RD

Time Frame

on 12 months

Title

Overall survival

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xinxin Cao

Phone

18618315968

caoxinxin@pumch.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dao-bin Zhou

Organizational Affiliation

Peking Union Medical College Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Peking Union Medical College Hospital

City

Beijing

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xinxin Cao

12. IPD Sharing Statement

Learn more about this trial

Lenalidomide and Dexamethasone for Rosai-Dorfman Disease

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