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

Withdrawn

• Conditions: CLL; SLL; CLL/SLL; Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma
• Interventions: Other: Treatment Free Observation

• Registration Number: NCT04694560
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-22
• Study First Submitted: 2020-12-28
• Study First Submitted QC: 2021-01-04
• Study First Posted: 2021-01-05
• Status Verified: 2023-03
• Primary Completion: 2023-03-06
• Study Completion: 2023-03-06
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-16

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CLL/SLL	Treatment Free Observation	Diagnosis of CLL or SLL confirmed by the enrolling institution

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Atrium Health (Data Collection Only); 🇺🇸 Monroe, North Carolina, United States

University of Pennsylvania (Data Collection Only); 🇺🇸 Philadelphia, Pennsylvania, United States