An open-label continuation trial of sirolimus for tocilizumab-refractory idiopathic multicentric Castleman's disease: Study protocol for an investigator-initiated, multicenter, open-label trial (SPIRIT Compliant)

Phase 3

• Conditions: idiopathic multicentric Castleman's disease; Castleman's disease

• Registration Number: JPRN-jRCT2051200050
• Lead Sponsor: Kawakami Atsushi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-08-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Patients may be included if all of the following criteria are met:
(1) Patients who have completed 16-week treatment with investigational drug treatment in the preceding trial
(2) Patients who have received a thorough explanation of the contents of explanatory documents and other matters concerning clinical trials understood the contents thereof and provided written consent based on their free will to participate in this trial. In case the patient is under 20 years of age at the time of obtaining the consent, the patient has obtained written consent to participate in the clinical trial from the proxy and written consent to participate in the clinical trial from the patient himself/herself.

Exclusion Criteria

Patients with any one of the following will be excluded
(1) Patients with an Eastern Cooperative Oncology Group Performance Status of 4.
(2) Patients (males and females of childbearing potential) who are unable to use an appropriate method of contraception during the period of study drug administration and 12 weeks after the last dose of study drug
(3) Female patients who are breastfeeding or pregnant
(4) Patients with complications of serious diseases that are deemed unsuitable for the clinical trial by the investigator or sub-investigator
(5) Patients whose condition in a prior study is deemed unsuitable for continued treatment by the investigator or subinvestigator
(6) Other patients who deemed inappropriate by the investigator or sub-investigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified