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

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ClinicalTrials.gov Identifier: NCT04694560
Recruitment Status : Recruiting
First Posted : January 5, 2021
Last Update Posted : January 5, 2021
Sponsor:
Collaborator:
Pharmacyclics LLC.
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
CLL SLL CLL/SLL Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma Other: Treatment Free Observation

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Study Type : Observational
Estimated Enrollment : 75 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : December 22, 2020
Estimated Primary Completion Date : December 22, 2022
Estimated Study Completion Date : December 22, 2022


Group/Cohort Intervention/treatment
CLL/SLL
Diagnosis of CLL or SLL confirmed by the enrolling institution
Other: Treatment 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.




Primary Outcome Measures :
  1. Tumor Free Survival rate [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04694560


Contacts
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Contact: Anthony Mato, MD 646-608-3748 matoa@mskcc.org
Contact: Lindsey Roeker, MD 646-608-4115 roekerl@mskcc.org

Locations
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United States, New York
Memorial Sloan Kettering Cancer Center (All Protocol Activities) Recruiting
New York, New York, United States, 10065
Contact: Anthony Mato, MD    646-608-3748      
United States, North Carolina
Atrium Health (Data Collection Only) Not yet recruiting
Monroe, North Carolina, United States, 28112
Contact: Ryan Jacobs, MD    980-442-4363      
United States, Pennsylvania
University of Pennsylvania (Data Collection Only) Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104-4283
Contact: Stephen Schuster, MD    215-316-5151      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Pharmacyclics LLC.
Investigators
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Principal Investigator: Anthony Mato, MD Memorial Sloan Kettering Cancer Center
Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT04694560    
Other Study ID Numbers: 20-284
First Posted: January 5, 2021    Key Record Dates
Last Update Posted: January 5, 2021
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
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
Additional relevant MeSH terms:
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Lymphoma
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell