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

NCT04694560 | Withdrawn DMC FDA Drug

• 1 other identifier: 20-284
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (1)

• Tumor Free Survival rate

  Participants will be evaluated by iwCLL / International Workshop on Chronic Lymphocytic Leukemia criteria

  At the end of Cycle 24 (each cycle is 28 days) cycles +/- 14 days

Study Arms (1)

CLL/SLL

Diagnosis of CLL or SLL confirmed by the enrolling institution

Other: Treatment Free Observation

Interventions

Treatment Free Observation 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.

CLL/SLL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• ≥ 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Pharmacyclics LLC.: collaborator

Study Sites (2)

Atrium Health (Data Collection Only)

Monroe, North Carolina, 28112, United States

Location

University of Pennsylvania (Data Collection Only)

Philadelphia, Pennsylvania, 19104-4283, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Anthony Mato, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2020
• First Posted: January 5, 2021
• Study Start: December 22, 2020
• Primary Completion: March 6, 2023
• Study Completion: March 6, 2023
• Last Updated: May 16, 2025

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share

Locations

US (2)