Status:
WITHDRAWN
A Time-Limited Approach to Treatment With Ibrutinib for Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
Pharmacyclics LLC.
Conditions:
CLL
SLL
Eligibility:
All Genders
18+ years
Brief Summary
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...
Eligibility Criteria
Inclusion
- ≥ 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:
- Ibrutinib monotherapy
- 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.
- CR with or without U-MRD in peripheral blood
- PR with U-MRD in peripheral blood
Exclusion
- 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).
Key Trial Info
Start Date :
December 22 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 6 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04694560
Start Date
December 22 2020
End Date
March 6 2023
Last Update
May 16 2025
Active Locations (2)
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1
Atrium Health (Data Collection Only)
Monroe, North Carolina, United States, 28112
2
University of Pennsylvania (Data Collection Only)
Philadelphia, Pennsylvania, United States, 19104-4283