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Efficacy and Safety of the RD Regimen(Lenalidomide, Dexamethasone) for Rosai-Dorfman Disease

ConditionRosai-Dorfman Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences

About this trial

In patients with Rosai-Dorfman disease (RDD), a treatment regimen of lenalidomide combined with dexamethasone is planned to be used.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Definitively diagnosed adult RDD patients;

Aged between 18 and 80 years;

Treatment-naive or refractory/relapsed;

ECOG performance status score ≤ 2;

Disqualifiers

Subjects who have undergone major surgery within 4 weeks prior to the first dose of the study;

Subjects who have received radiotherapy within 4 weeks prior to the first dose of the study;

Subjects with a history of myocardial infarction within the past year;

Patients with New York Heart Association (NYHA) Class 3 or 4 congestive heart failure, or a history of NYHA Class 3 or 4 congestive heart failure;

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Patients with RDDExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
From enrollment to the end of treatment at 8 weeks

Secondary outcomes

1

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) .

Time frame
From enrollment to the end of treatment at 8 weeks
2

Overall Survival (OS)

OS was measured from RD start to death or last follow-up

Time frame
From enrollment to the end of treatment at 8 weeks"
3

Adverse events

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

Other outcomes

1

Correlation between next-generation sequence (NGS) and therapeutic efficacy/PFS

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"
2

Fact-G

The score of Functional Assessment of Cancer Therapy - General

Time frame
From enrollment to the end of treatment at 8 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Lead sponsor

Source ClinicalTrials.gov
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