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Withdrawn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)

Enrollment

Locations

Anticipated Duration (Months)

Patients Per Site

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 Disease	Intervention/Treatment	Phase
CLL SLL CLL/SLL Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma	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

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

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:

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

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

	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