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Trial Title:
Ibrutinib for the Treatment of AIHA in Patients With CLL/SLL or CLL-like MBL
NCT ID:
NCT05694312
Condition:
Autoimmune Hemolytic Anemia
Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Monoclonal B-Cell Lymphocytosis CLL-Type
Conditions: Official terms:
Lymphoma
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Anemia
Anemia, Hemolytic
Anemia, Hemolytic, Autoimmune
Lymphocytosis
Hemolysis
Ibrutinib
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Ibrutinib 420 mg
Description:
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.
Arm group label:
Ibrutinib
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Ematologia Osp Careggi
Address:
City:
Firenze
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Alessandro Sanna
Facility:
Name:
Ematologia Osp Maggiore della Carità
Address:
City:
Novara
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Riccardo Moia
Facility:
Name:
Ematologia Osp Molinette
Address:
City:
Torino
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Marta Coscia
Start date:
November 24, 2023
Completion date:
November 2026
Lead sponsor:
Agency:
Gruppo Italiano Malattie EMatologiche dell'Adulto
Agency class:
Other
Source:
Gruppo Italiano Malattie EMatologiche dell'Adulto
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05694312
