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Siltuximab In Siltuximab-RElapsed/REfractory Multicentric CAstleman Disease

NCT04838860 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2021-04-19

No results posted yet for this study

Summary

Phase 2 study to investigate the safety, tolerability, and efficacy of administering increased siltuximab doses to patients with iMCD

Conditions

  • Idiopathic Multicentric Castleman's Disease

Interventions

DRUG

Siltuximab

Participants will receive intravenous (IV) infusion of siltuximab 22 mg/kg over 2 hours every 3 weeks, then possibly dose escalating to 33 mg/kg IV over 3 hours +/- 44 mg/kg IV over 4 hours every 3 weeks if clinically indicated in the absence of dose-limiting toxicity.

Sponsors & Collaborators

  • RECORDATI GROUP

    lead INDUSTRY

Principal Investigators

  • Chris Keuker, MD · Syneos Health

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-31
Primary Completion
2021-04-01
Completion
2021-04-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04838860 on ClinicalTrials.gov