Bortezomib-dexamethasone combination for the treatment of patients with warm autoimmune hemolytic anemia
Phase 2
- Conditions
- Health Condition 1: D591- Other autoimmune hemolytic anemias
- Registration Number
- CTRI/2024/03/064428
- Lead Sponsor
- Safdarjung Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Adult patients 18 to 60 years of age and of either sex diagnosed with wAIHA (idiopathic, or secondary to an autoimmune disorder) who are relapsed, or refractory (RR) to prednisolone and single agent rituximab as first and second-line therapies, respectively and require initiation of third-line treatment will be included.
Exclusion Criteria
Patients with wAIHA less than 18 years of age, wAIHA secondary to a lymphoproliferative disorder and those unwilling to participate in the study will be excluded
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy (Response rates) and safety of bortezomib-dexamethasone as third-line therapy in wAIHA.Timepoint: 1-month, 3-months, 6-months, 1-year
- Secondary Outcome Measures
Name Time Method Feasibility of achieving a treatment-free remission (TFR) after bortezomib discontinuation.Timepoint: 6-months, 1-year and 2-years