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

Primary Purpose

Autoimmune Hemolytic Anemia, Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Ibrutinib 420 mg
Sponsored by
Gruppo Italiano Malattie EMatologiche dell'Adulto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autoimmune Hemolytic Anemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Diagnosis of CLL/small lymphocytic lymphoma (SLL) or CLL-like monoclonal B-cell lymphocytosis (MBL) according to IWCLL guidelines. Patients >18 years old 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). Eligibility of patients with DAT-negative active AIHA should be confirmed by the Principal Investigator and co-Principal Investigator for the trial. Signed written informed consent according to ICH/EU/GCP and national local laws. Exclusion Criteria: Contraindication to ibrutinib therapy as per treating physician's discretion. 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). Previous exposure to ibrutinib as CLL-directed therapy. Other CLL/SLL- or AIHA-directed treatment at the time of enrollment in the study, other than corticosteroids. Female patients who are currently in pregnancy or are willing to be pregnant or are lactating.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Ibrutinib

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    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)

    Secondary Outcome Measures

    Full Information

    First Posted
    January 12, 2023
    Last Updated
    January 12, 2023
    Sponsor
    Gruppo Italiano Malattie EMatologiche dell'Adulto
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05694312
    Brief Title
    Ibrutinib for the Treatment of AIHA in Patients With CLL/SLL or CLL-like MBL
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 2023 (Anticipated)
    Primary Completion Date
    October 2024 (Anticipated)
    Study Completion Date
    April 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Gruppo Italiano Malattie EMatologiche dell'Adulto

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Autoimmune Hemolytic Anemia, Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Monoclonal B-Cell Lymphocytosis CLL-Type

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    45 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Ibrutinib
    Arm Type
    Experimental
    Arm Description
    Patients will receive ibrutinib 420 mg/day orally for up to 12 cycles of 28 days.
    Intervention Type
    Drug
    Intervention Name(s)
    Ibrutinib 420 mg
    Intervention 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.
    Primary Outcome Measure Information:
    Title
    Ibrutinib efficacy in terms of Overall response rate
    Description
    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)
    Time Frame
    at month 6

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosis of CLL/small lymphocytic lymphoma (SLL) or CLL-like monoclonal B-cell lymphocytosis (MBL) according to IWCLL guidelines. Patients >18 years old 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). Eligibility of patients with DAT-negative active AIHA should be confirmed by the Principal Investigator and co-Principal Investigator for the trial. Signed written informed consent according to ICH/EU/GCP and national local laws. Exclusion Criteria: Contraindication to ibrutinib therapy as per treating physician's discretion. 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). Previous exposure to ibrutinib as CLL-directed therapy. Other CLL/SLL- or AIHA-directed treatment at the time of enrollment in the study, other than corticosteroids. Female patients who are currently in pregnancy or are willing to be pregnant or are lactating.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Paola Fazi
    Phone
    0670390528
    Email
    p.fazi@gimema.it
    First Name & Middle Initial & Last Name or Official Title & Degree
    Enrico Crea
    Phone
    0670390514
    Email
    e.crea@gimema.it

    12. IPD Sharing Statement

    Learn more about this trial

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

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