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Phase II prospective treatment study for IgG4+MOLPS

Phase 2
Conditions
IgG4+MOLPS (IgG4+Multiorgan lymphoproliferative syndrome)
Registration Number
JPRN-UMIN000002311
Lead Sponsor
Department of Hematology and Immunology, Kanazawa Medical University
Brief Summary

RESULTS: This study enrolled 61 patients. After clinicopathological review, three patients were excluded, and one, 13, and 44 patients were diagnosed with probable, possible, and definite IgG4-related disease, respectively. Of the 44 patients with definite IgG4-RD, 29 (65.9%) achieved CR, and the ORR was 93.2%. No patient was refractory to primary treatment. The most frequent adverse events were glucose intolerance. Six patients relapsed. CONCLUSIONS: Glucocorticoid treatment is usually effective for patients with IgG4-RD, and we should examine the possibility of other disorders when a patient is glucocorticoid refractory. Some patients are misdiagnosed, making central clinicopathological review of diagnosis very important in conducting clinical studies.

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
57
Inclusion Criteria

Not provided

Exclusion Criteria

1, Castleman disease, Wegener granulomatosis, Sarcoidosis, cancer lymphoma, and other distinct disorders. 2, severe infectious disease 3, pre-treatment of steroid or immuno-suppressive drugs 4, physician's decision

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
CR rate
Secondary Outcome Measures
NameTimeMethod
Maintenance dose of steroid, relapse rate, adverse effects
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