Chronic Lymphocytic Leukemia, CLL, CLL/SLL, SLL, Small Lymphocytic Lymphoma
Conditions
Keywords
Small Lymphocytic Lymphoma, Chronic Lymphocytic Leukemia, CLL/SLL, SLL, CLL, Ibrutinib, Ibrutinib monotherapy, anti-CD20 monoclonal antibody, MRD, U-MRD, 20-284, Memorial Sloan Kettering Cancer Center
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 have achieved complete or partial remission of their disease.
Interventions
OTHERTreatment 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.
Sponsors
Pharmacyclics LLC.
Memorial Sloan Kettering Cancer Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tumor Free Survival rate | At the end of Cycle 24 (each cycle is 28 days) cycles +/- 14 days | Participants will be evaluated by iwCLL / International Workshop on Chronic Lymphocytic Leukemia criteria |
Countries
United States
Outcome results
None listed