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

Chronic Lymphocytic Leukemia Clinical Trial

Official title:

Ibrutinib for the Treatment of Autoimmune Hemolytic Anemia in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma or CLL-like Monoclonal B-cell Lymphocytosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05694312
• Other study ID #: CLL2323
• Status: Recruiting
• Phase: Phase 2
• Start date: November 24, 2023
• Est. completion date: November 2026

Study information

• Verified date: November 2023
• Source: Gruppo Italiano Malattie EMatologiche dell'Adulto
• Contact: Paola Fazi
• Phone: 0670390528
• Email: p.fazi[@]gimema.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: November 2026
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Diagnosis of CLL/small lymphocytic lymphoma (SLL) or CLL-like monoclonal B-cell lymphocytosis (MBL) according to IWCLL guidelines.

2. Patients >18 years old

3. Active AIHA (wAIHA or CAD) that i) is relapsed after previous treatment with corticosteroids (with or without rituximab), or ii) is steroid-resistant (failure to obtain hematologic response within 3 weeks on at least 1 mg/kg predniso(lo)ne), or iii) is steroid-dependent (need to continue on predniso(lo)ne at a dose of >10 mg/day to maintain a response). AIHA is defined as: anemia (hemoglobin =10 g/dL; or hemoglobin >10 g/dL dependent on transfusions to maintain this level of hemoglobin) and laboratory evidence of hemolysis (presence of 3 of 4 markers: increased reticulocyte count, increased indirect bilirubin, increased lactate dehydrogenase, decreased haptoglobin) and positive DAT (either IgG DAT, C3 DAT or both).

4. Eligibility of patients with DAT-negative active AIHA should be confirmed by the Principal Investigator and co-Principal Investigator for the trial.

5. Signed written informed consent according to ICH/EU/GCP and national local laws.

Exclusion Criteria:

1. Contraindication to ibrutinib therapy as per treating physician's discretion.

2. Contraindication to ibrutinib therapy as per ibrutinib data sheet (severe hepatic impairment, known allergy to the drug or to one of the excipients, concomitant treatment with warfarin or other vitamin K antagonists).

3. Previous exposure to ibrutinib as CLL-directed therapy.

4. Other CLL/SLL- or AIHA-directed treatment at the time of enrollment in the study, other than corticosteroids.

5. Female patients who are currently in pregnancy or are willing to be pregnant or are lactating.

Related Conditions & MeSH terms

• Anemia
• Anemia, Hemolytic
• Anemia, Hemolytic, Autoimmune
• Autoimmune Hemolytic Anemia
• Chronic Lymphocytic Leukemia
• Hemolysis
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Lymphocytosis
• Lymphoma
• Small Lymphocytic Lymphoma

Intervention

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.

Locations

Country	Name	City	State
Italy	Ematologia Osp Careggi	Firenze
Italy	Ematologia Osp Maggiore della Carità	Novara
Italy	Ematologia Osp Molinette	Torino

Sponsors (1)

Lead Sponsor	Collaborator
Gruppo Italiano Malattie EMatologiche dell'Adulto

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ibrutinib efficacy in terms of Overall response rate	Evaluation of the efficacy of ibrutinib therapy for the treatment of AIHA in patients with CLL/SLL or CLL-like MBL in terms of percentage of patients who achieved response (CR + PR)	at month 6