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

Sponsor
Memorial Sloan Kettering Cancer Center (Other)
Overall Status
Withdrawn
CT.gov ID
NCT04694560
Collaborator
Pharmacyclics LLC. (Industry)
0
Enrollment
9
Locations
24
Anticipated Duration (Months)
0
Patients Per Site
0
Patients Per Site Per Month

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 DiseaseIntervention/TreatmentPhase
  • Other: Treatment Free Observation

Study Design

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

Arms and Interventions

ArmIntervention/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.

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

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

SiteCityStateCountryPostal Code
1Memoral Sloan Kettering Basking Ridge (All protocol activities)Basking RidgeNew JerseyUnited States07920
2Memoral Sloan Kettering Monmouth (All protocol activities)MiddletownNew JerseyUnited States07748
3Memorial Sloan Kettering Bergen (All protocol activities)MontvaleNew JerseyUnited States07645
4Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (All protocol activities)CommackNew YorkUnited States11725
5Memoral Sloan Kettering Westchester (All protocol activities)HarrisonNew YorkUnited States10604
6Memorial Sloan Kettering Cancer Center (All Protocol Activities)New YorkNew YorkUnited States10065
7Memorial Sloan Kettering Nassau (All protocol activities)UniondaleNew YorkUnited States11553
8Atrium Health (Data Collection Only)MonroeNorth CarolinaUnited States28112
9University of Pennsylvania (Data Collection Only)PhiladelphiaPennsylvaniaUnited States19104-4283

Sponsors and Collaborators

  • Memorial Sloan Kettering Cancer Center
  • Pharmacyclics LLC.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT04694560
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:
Yes
Plan to Share IPD:
Yes
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 18, 2022