Bortezomib-dexamethasone combination for the treatment of patients with warm autoimmune hemolytic anemia

Weekly bortezomib-dexamethasone as a third-line therapy for patients with warm autoimmune hemolytic anemia - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/03/064428

Enrollment

Registered

2024-03-19

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: D591- Other autoimmune hemolytic anemias

Interventions

Intervention1: Bortezomib-dexamethasone: Bortezomib-dexamethasone will be administered once every week in patients with warm autoimmune hemolytic anaemia (wAIHA) who fail both prednisolone and rituxim

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Efficacy (Response rates) and safety of bortezomib-dexamethasone as third-line therapy in wAIHA.Timepoint: 1-month, 3-months, 6-months, 1-year	—

Secondary

Measure	Time frame
Feasibility of achieving a treatment-free remission (TFR) after bortezomib discontinuation.Timepoint: 6-months, 1-year and 2-years	—

Countries

India

Contacts

Public ContactDr Ankur Jain

Vardhman Mahavir Medical College and Safdarjung Hospital

drankur589@yahoo.in9910265555

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026