Trials / Recruiting
RecruitingNCT05694312
Ibrutinib for the Treatment of AIHA in Patients With CLL/SLL or CLL-like MBL
Ibrutinib for the Treatment of Autoimmune Hemolytic Anemia in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma or CLL-like Monoclonal B-cell Lymphocytosis
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 45 (estimated)
- Sponsor
- Gruppo Italiano Malattie EMatologiche dell'Adulto · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a multicenter, single arm, phase II study aimed at evaluating ibrutinib therapy for the treatment of AIHA in patients with CLL/SLL or CLL-like MBL.
Detailed description
This is a multicenter, phase II study to assess the efficacy of ibrutinib for the treatment of AIHA in adult patients with CLL/SLL or CLL-like MBL. Patients will receive ibrutinib 420 mg/day PO for up to 12 cycles of 28 days in the absence of CLL progression or unacceptable toxicity. Every patient will be followed-up for 1 year after the completion of study treatment.
Conditions
- Autoimmune Hemolytic Anemia
- Chronic Lymphocytic Leukemia
- Small Lymphocytic Lymphoma
- Monoclonal B-Cell Lymphocytosis CLL-Type
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ibrutinib 420 mg | Patients will receive ibrutinib orally on days 1-28. Treatment repeats every 28 days for up to 12 cycles in the absence of CLL progression or unacceptable toxicity. |
Timeline
- Start date
- 2023-11-24
- Primary completion
- 2025-05-01
- Completion
- 2026-11-01
- First posted
- 2023-01-23
- Last updated
- 2023-12-01
Locations
3 sites across 1 country: Italy
Source: ClinicalTrials.gov record NCT05694312. Inclusion in this directory is not an endorsement.