Veneto-STOP Study: Sequential Assessment of Minimal Residual Disease by Next Generation Sequencing to Optimize Outcomes and Minimize Exposure in Venetoclax-Treated CLL/SLL Patients

Who is this study for? Adults with chronic lymphocytic leukemia or small lymphocytic lymphoma
Status: Recruiting
Location: See all (9) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This study will find out whether people with CLL or SLL who have received treatment with venetoclax, either alone or in combination with another drug, and who are found to be MRD-negative, can stop treatment with venetoclax and remain off-treatment for 12 months or more. The researchers will also see whether study participants remain MRD-negative after they stop treatment with venetoclax.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• ≥ 18-years-old

• Diagnosis of chronic lymphocytic leukemia or small lymphocytic lymphoma confirmed by the enrolling institution

• Receiving treatment or planning to receive treatment within 30 days with a venetoclax-based regimen as defined below:

‣ Venetoclax monotherapy

⁃ Venetoclax in combination with anti CD20 monoclonal antibody (Patients must have completed the anti CD20 monoclonal antibody portion of the regimen prior to discontinuing therapy)

• Patient has or will have specimen to identify the CLL or SLL clone(s) for future MRD assessments by clonoSEQ® defined as any of the following:

‣ 3-5 bone marrow aspirate slides (banked), 3-5 FFPE slides (banked), banked tumor cells or banked DNA collected from the patient at any time from original diagnosis of CLL or SLL to present

⁃ Peripheral blood, marrow, or lymph node involvement for fresh sample collection

• The screening ID sample (high disease burden sample) can be sent prior to start of venetoclax-based therapy to identify the clone for tracking.

• Patients must have received venetoclax-based therapy for at least 6 months (including dose interruptions)

• If receiving venetoclax in combination with anti-CD20 monoclonal antibody, patients must have completed or discontinued the anti CD20 monoclonal antibody portion of the regimen prior to discontinuing therapy

• Patients must have two MRD-negative assessments (defined by ≥ 10\^-5 sensitivity) on the peripheral blood by the clonoSEQ® assay at least 28 days apart. Given that MRD status is a dynamic endpoint which may improve with time, if a patient is screen failure based on MRD status (i.e. MRD positive at the 10-5 sensitivity), they may be rescreened to assess for study eligibility.

• Patients must have achieved a complete or partial remission with the venetoclax-based regimen. Criteria for remission are per iwCLL 2018 guidelines. For this protocol, bone marrow biopsy/aspirate evaluation is not necessary to determine remission status.

Locations
United States
New Jersey
Memorial Sloan Kettering Basking Ridge (All protocol activities)
RECRUITING
Basking Ridge
Memorial Sloan Kettering Monmouth (All protocol activities)
RECRUITING
Middletown
Memorial Sloan Kettering Bergen (All protocol activities)
RECRUITING
Montvale
New York
Memorial Sloan Kettering Commack (All protocol activities)
RECRUITING
Commack
Memorial Sloan Kettering Westchester (All protocol activities)
RECRUITING
Harrison
Columbia University
ACTIVE_NOT_RECRUITING
New York
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
RECRUITING
New York
Memorial Sloan Kettering Nassau (All protocol activities)
RECRUITING
Uniondale
Washington
University of Washington
ACTIVE_NOT_RECRUITING
Seattle
Contact Information
Primary
Meghan Thompson, MD
thompsm2@mskcc.org
646-608-4253
Backup
Mark Geyer, MD
646-608-3745
Time Frame
Start Date: 2020-05-13
Estimated Completion Date: 2026-05
Participants
Target number of participants: 80
Treatments
Experimental: Venetoclax monotherapy
Experimental: Venetoclax with anti-CD20 monoclonal antibody
Sponsors
Collaborators: Adaptive Biotechnologies
Leads: Memorial Sloan Kettering Cancer Center

This content was sourced from clinicaltrials.gov