A Time-Limited Approach to Treatment With Ibrutinib for Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-22

Study Completion Date

2023-03-06

Brief Summary

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The purpose of this study is to find out whether people with CLL or SLL who are currently receiving treatment with ibrutinib can stop treatment and remain off-treatment for at least 12 months, if they have achieved complete or partial remission of their disease.

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Detailed Description

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Conditions

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CLL SLL CLL/SLL Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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CLL/SLL

Diagnosis of CLL or SLL confirmed by the enrolling institution

Treatment Free Observation

Intervention Type OTHER

Participants without evidence of clinical relapse will remain off therapy and continue serial monitoring through end of study at 24 cycles. Participants with clinical relapse will continue to be monitored off therapy through 24 cycles or until meeting criteria for treatment per iwCLL criteria. If participants experience clinical relapse requiring treatment, radiology assessment, disease assessment, and testing for resistance mutations will be performed. Participants will be observed for an additional 12 cycles following start of reintroduction of therapy.

Interventions

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Treatment Free Observation

Participants without evidence of clinical relapse will remain off therapy and continue serial monitoring through end of study at 24 cycles. Participants with clinical relapse will continue to be monitored off therapy through 24 cycles or until meeting criteria for treatment per iwCLL criteria. If participants experience clinical relapse requiring treatment, radiology assessment, disease assessment, and testing for resistance mutations will be performed. Participants will be observed for an additional 12 cycles following start of reintroduction of therapy.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* ≥ 18-years-old
* Diagnosis of CLL or SLL confirmed by the enrolling institution
* Negative del(17p) test confirmed by FISH testing prior to initiating treatment with ibrutinib
* Receiving commercial treatment with an ibrutinib-based regimen in the front-line setting as defined below with the intent to discontinue therapy on C1D1:

1. Ibrutinib monotherapy
2. Ibrutinib in combination with anti-CD20 monoclonal antibody (Patients must have completed the anti-CD20 monoclonal antibody portion of the regimen prior to signing consent)
* Patients must have received ibrutinib-based therapy for at least 15 months. Dose interruptions and reductions during this treatment period may have been carried out per treating provider discretion.
* Response evaluation performed by radiology assessment (CT or MRI imaging of neck / chest / abdomen / pelvis) confirming complete remission or partial remission by iwCLL criteria.
* Peripheral blood (by flow cytometry per institutional standards) testing for MRD confirming U-MRD to a sensitivity of 10\^-4. MRD testing must be confirmed to follow ERIC consensus criteria.

1. CR with or without U-MRD in peripheral blood
2. PR with U-MRD in peripheral blood

Exclusion Criteria

* Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator's opinion, could compromise the subject's safety or put the study outcomes at undue risk..
* Unwilling or unable to participate in all required study evaluations and procedures. Unable to understand the purpose and risks of the study and to provide a signed and dated informed consent form (ICF) and authorization to use protected health information (in accordance with national and local patient privacy regulations).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes