Ibrutinib for the Treatment of AIHA in Patients With CLL/SLL or CLL-like MBL

Sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto
Study ID
NCT05694312
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ibrutinib 420 mg — DRUG
    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.

Study Details

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.

Key Dates

Start date
Nov 24, 2023
Status verified
Nov 2023
Primary completion
May 31, 2025
Completion
Nov 30, 2026

Study Design

Enrollment
45 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ibrutinib
    Patients will receive ibrutinib 420 mg/day orally for up to 12 cycles of 28 days.

Primary Outcome Measure

Ibrutinib efficacy in terms of Overall response rate [ Time Frame: at month 6 ]

Central Contacts

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