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

Memorial Sloan Kettering Cancer Center (Other)
Overall Status
CT.gov ID
Pharmacyclics LLC. (Industry)

Study Details

Study Description

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 Phase
  • Other: Treatment Free Observation

Study Design

Study Type:
Actual Enrollment :
0 participants
Observational Model:
Time Perspective:
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 :
Dec 22, 2020
Anticipated Primary Completion Date :
Dec 22, 2022
Anticipated Study Completion Date :
Dec 22, 2022

Arms and Interventions

Arm Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

  1. 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

Eligibility Criteria


Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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).

Contacts and Locations


Site City State Country Postal Code
1 Memoral Sloan Kettering Basking Ridge (All protocol activities) Basking Ridge New Jersey United States 07920
2 Memoral Sloan Kettering Monmouth (All protocol activities) Middletown New Jersey United States 07748
3 Memorial Sloan Kettering Bergen (All protocol activities) Montvale New Jersey United States 07645
4 Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (All protocol activities) Commack New York United States 11725
5 Memoral Sloan Kettering Westchester (All protocol activities) Harrison New York United States 10604
6 Memorial Sloan Kettering Cancer Center (All Protocol Activities) New York New York United States 10065
7 Memorial Sloan Kettering Nassau (All protocol activities) Uniondale New York United States 11553
8 Atrium Health (Data Collection Only) Monroe North Carolina United States 28112
9 University of Pennsylvania (Data Collection Only) Philadelphia Pennsylvania United States 19104-4283

Sponsors and Collaborators

  • Memorial Sloan Kettering Cancer Center
  • Pharmacyclics LLC.


  • Principal Investigator: Anthony Mato, MD, Memorial Sloan Kettering Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:


None provided.
Responsible Party:
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
Other Study ID Numbers:
  • 20-284
First Posted:
Jan 5, 2021
Last Update Posted:
Mar 18, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Keywords provided by Memorial Sloan Kettering Cancer Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 18, 2022