Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Ministry of Health, Thailand | OTHER_GOV |
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bortezomib and cyclophosphamide | Experimental | Two cycles of bortezomib administered subcutaneously, followed by 4 months of low dose oral cyclophosphamide. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bortezomib | Drug | Bortezomib will be subcutaneously administered in 2 treatment cycles with 4 injections of 1.3 mg Bortezomib /m2 body surface per cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Titers of anti-interferon-gamma antibody after treatment with bortezomib | Change in titers of anti-interferon-gamma antibody after treatment with | 8 weeks after first dose of bortezomib (after completion 2 cycles of bortezomib) |
| Titers of anti-interferon-gamma antibody after treatment with bortezomib and cyclophosphamide | Change in titers of anti-interferon-gamma antibody after treatment with bortezomib and cyclophosphamide | 1 year after first dose of bortezomib |
| Adverse event | Grade 4 adverse event (probably related) | 6 months after first dose of bortezomib (after completion 4 months of cyclophosphamide) |
| Measure | Description | Time Frame |
|---|---|---|
| Disease relapse | Worsening of symptoms and signs | 6 month and 1 year after first dose of bortezomib |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nasikarn Angkasekwinai, MD. | Contact | 6681-8708766 | nasikarn@gmail.com | |
| Yupin Suputtamongkol, MD. | Contact | 662-4197783 | ysuputtamongkol@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Nasikarn Angkasekwinai, MD. | Faculty of Mdicine Siriraj Hospital, Mahidol University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine Siriraj Hospital, Mahidol University | Recruiting | Bangkok | Bangkok | 10700 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37947190 | Derived | Angkasekwinai N, Suputtamongkol Y, Tantibhedhyangkul W, Onlamoon N, Phoompoung P, Pithukpakorn M, Karuphong E, Pusuwan P, Angkasekwinai P. Efficacy of Bortezomib for Treating Anti-Interferon-Gamma Autoantibody-Associated Adult-Onset Immunodeficiency Syndrome. Clin Infect Dis. 2024 Apr 10;78(4):1033-1042. doi: 10.1093/cid/ciad676. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000069286 | Bortezomib |
| D003520 | Cyclophosphamide |
| ID | Term |
|---|---|
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Cyclophosphamide | Drug | Low dose cyclophosphamide will be given orally for 4 month after completion 2 cycles of bortezomib |
|
|
| D001896 |
| Boron Compounds |
| D009930 | Organic Chemicals |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |