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.
Recruiting
Phase 2
| Drug | Synonyms | Arms |
|---|---|---|
| Venetoclax monotherapy | Venetoclax monotherapy | |
| Venetoclax with anti CD20 monoclonal antibody | Venetoclax with anti-CD20 monoclonal antibody |
Screening Phase:
Patients will be identified by clinical investigators at participating centers. Patients who
sign the screening consent patients will undergo an MRD assessment with the clonoSEQ® assay.
If the assessment identifies the patient to be MRD negative, the patient will undergo a
repeat MRD assessment no less than 28 days later. If two consecutive MRD assessments indicate
MRD-negativity, the patient will then be directed to sign the study intervention phase
informed consent form and will undergo the rest of the screening process.
Enrollment
Once the patient fulfills all eligibility criteria, the patient will be enrolled into one of
two cohorts based on the type of therapy they are receiving at the time of enrolled:
Cohort A: Venetoclax monotherapy at time of enrollment.
Cohort B: Venetoclax with anti CD20 monoclonal antibody at time of enrollment (The latter
includes patients who initiated anti CD20 monoclonal antibody with venetoclax and have since
completed the anti CD20 monoclonal antibody portion of the regimen.)
| Name | Type | Description | Interventions |
|---|---|---|---|
| Venetoclax monotherapy | Experimental |
| |
| Venetoclax with anti-CD20 monoclonal antibody | Experimental |
|
Screening Phase Inclusion Criteria:
- ≥ 18-years-old
- Diagnosis of chronic lymphocytic leukemia or small lymphocytic lymphoma confirmed by
the enrolling institution
- Receiving treatment 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)
- Patients must be receiving commercially supplied venetoclax (and anti CD20 monoclonal
antibody)Have 3-5 bone marrow aspirate slides (fresh or banked), 3-5 FFPE slides
(fresh or banked), available banked tumor cells or DNA, or fresh blood sample
collected from the patient at any time from original diagnosis of CLL/SLL to present
to identify the CLL/SLL clone(s) for future MRD assessments by clonoSEQ®.
- The screening ID sample (high disease burden sample) can be sent prior to start of
venetoclax-based therapy to identify the clone for tracking.
Study Intervention Phase Inclusion Criteria:
- Patients must have received venetoclax-based therapy for at least 6 months (including
dose interruptions)
- 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.
Exclusion Criteria (both study phases):
- Participation in a clinical trial that supplies venetoclax and/or anti CD20 monoclonal
antibody
- 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).
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
| Measure: | Proportion of patients able to remain off CLL/SLL directed therapy |
| Time Frame: | 2 years |
| Safety Issue: | |
| Description: | This will be described as a percentage of all patients with available data at 12 cycles of follow up (evaluable population). |
| Phase: | Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Memorial Sloan Kettering Cancer Center |
May 19, 2021
