NCT03103555

Treatment of Adult-Onset Immunodeficiency With Bortezomib

Treatment of Anti-Interferon-Gamma Autoantibody Associated Acquired Immunodeficiency Syndrome With Bortezomib: Pilot Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (estimated)
• Sponsor: Mahidol University · Academic / Other
• Sex: All
• Age: 21 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This is pilot study aimed to investigate the application of proteosome inhibitor, Bortezomib in treatment of patients with neutralizing autoantibody to IFN-γ. The investigators hypothesis is that bortezomib will reduce the antibody level and restore interferon-gamma function, resulting in clinical improvement and should be well-tolerated and safe for use in patients with autoantibody to IFN-γ.

Detailed description

The patients with autoantibody to IFN-γ and past or current history of proven opportunistic infection will receive 2 treatment cycles of bortezomib subcutaneously (4 injections of 1.3 mg Bortezomib /m2 body surface per cycle), followed by low dose oral cyclophosphamide for 4 month after completion treatment with bortezomib.

Conditions

• Adult-onset Immunodeficiency

Interventions

Type	Name	Description
DRUG	Bortezomib	Bortezomib will be subcutaneously administered in 2 treatment cycles with 4 injections of 1.3 mg Bortezomib /m2 body surface per cycle.
DRUG	Cyclophosphamide	Low dose cyclophosphamide will be given orally for 4 month after completion 2 cycles of bortezomib

Timeline

• Start date: 2017-02-27
• Primary completion: 2018-11-01
• Completion: 2019-11-01
• First posted: 2017-04-06
• Last updated: 2017-04-06

Locations

1 site across 1 country: Thailand