Clinical trial NCT04694560: A Time-Limited Approach to Treatment With Ibrutinib for Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma
Official title: A Phase 2 Time-Limited Approach to Front-Line Ibrutinib for Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Patients Who Achieve Complete Remission or Partial Remission With Undetectable Minimal Residual Disease
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: CLL
SLL
CLL/SLL
Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
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
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Pharmacyclics LLC.
First posted: 2021-01-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Potential research subjects will be identified by a member of the patient's treatment team, the protocol investigator, or research team at Memorial Sloan-Kettering Cancer Center (MSKCC). If the investigator is a member of the treatment team, s/he will screen their patient's medical records for suitable research study participants and discuss the study and their potential for enrolling in the research study. Potential subjects contacted by their treating physician will be referred to the investigator/research staff of the study. The principal investigator may also screen the medical records of patients with whom they do not have a treatment relationship for the limited purpose of identifying patients who would be eligible to enroll in the study and to record appropriate contact information in order to approach these patients regarding the possibility of enrolling in the study.

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Tumor Free Survival rate
timeFrame: At the end of Cycle 24 (each cycle is 28 days) cycles +/- 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Monroe
country: United States
facility: Atrium Health (Data Collection Only)
state: North Carolina
city: Philadelphia
country: United States
facility: University of Pennsylvania (Data Collection Only)
state: Pennsylvania
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Anthony Mato, MD
role: PRINCIPAL_INVESTIGATOR
References: