NCT05694312

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for phase_2

Timeline
6mo left

Started Nov 2023

Typical duration for phase_2

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress83%
Nov 2023Nov 2026

First Submitted

Initial submission to the registry

January 12, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 23, 2023

Completed
10 months until next milestone

Study Start

First participant enrolled

November 24, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Expected
Last Updated

December 1, 2023

Status Verified

November 1, 2023

Enrollment Period

1.4 years

First QC Date

January 12, 2023

Last Update Submit

November 28, 2023

Conditions

Autoimmune Hemolytic AnemiaChronic Lymphocytic LeukemiaSmall Lymphocytic LymphomaMonoclonal B-Cell Lymphocytosis CLL-Type

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Ibrutinib

EXPERIMENTAL

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

Drug: Ibrutinib 420 mg

Interventions

Ibrutinib 420 mgDRUG

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.

Ibrutinib

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Ematologia Osp Careggi

Florence, Italy

RECRUITING

Ematologia Osp Maggiore della Carità

Novara, Italy

RECRUITING

Ematologia Osp Molinette

Torino, Italy

RECRUITING

MeSH Terms

Conditions

Anemia, Hemolytic, AutoimmuneLeukemia, Lymphocytic, Chronic, B-Cell

Interventions

ibrutinib

Condition Hierarchy (Ancestors)

Anemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesAutoimmune DiseasesImmune System DiseasesLeukemia, B-CellLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Paola Fazi

CONTACT

0670390528p.fazi@gimema.it

Enrico Crea

CONTACT

0670390514e.crea@gimema.it

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2023

First Posted

January 23, 2023

Study Start

November 24, 2023

Primary Completion

May 1, 2025

Study Completion (Estimated)

November 1, 2026

Last Updated

December 1, 2023

Record last verified: 2023-11

Locations

IT(3)