Assessing Minimal Residual Disease by Next- Generation Sequencing to Minimize Exposure in People With CLL or SLL Who Have Been Treated With Venetoclax
Part of paid clinical trials in Basking Ridge, New Jersey.
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Study ID
- NCT04419519
- Phase
- PHASE2
- Status
- Active Not Recruiting
Conditions
- Chronic Lymphocytic Leukemia (CLL)
- Small Lymphocytic Lymphoma (SLL)
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Venetoclax monotherapy — DRUGVenetoclax monotherapy
- Venetoclax with anti CD20 monoclonal antibody — DRUGVenetoclax with anti CD20 monoclonal antibody
Study Details
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.
Key Dates
- Start date
- May 13, 2020
- Status verified
- Jan 2026
- Primary completion
- May 31, 2027
- Completion
- May 31, 2027
Study Design
- Enrollment
- 81 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Venetoclax monotherapy
- Experimental: Venetoclax with anti-CD20 monoclonal antibody
Primary Outcome Measure
Proportion of patients able to remain off CLL/SLL directed therapy [ Time Frame: 2 years ]
Locations (9)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Memorial Sloan Kettering Basking Ridge (All protocol activities) | Basking Ridge | New Jersey | 07920 | - |
| Memorial Sloan Kettering Monmouth (All protocol activities) | Middletown | New Jersey | 07748 | - |
| Memorial Sloan Kettering Bergen (All protocol activities) | Montvale | New Jersey | 07645 | - |
| Memorial Sloan Kettering Commack (All protocol activities) | Commack | New York | 11725 | - |
| Memorial Sloan Kettering Westchester (All protocol activities) | Harrison | New York | 10604 | - |
| Columbia University | New York | New York | 10032 | - |
| Memorial Sloan Kettering Cancer Center (All Protocol Activities) | New York | New York | 10065 | - |
| Memorial Sloan Kettering Nassau (All protocol activities) | Uniondale | New York | 11553 | - |
| University of Washington | Seattle | Washington | 98109 | - |
Find similar trials in Basking Ridge, NJ
By research site
Memorial Sloan Kettering Basking Ridge (All protocol activities)· Basking Ridge, NJMemorial Sloan Kettering Monmouth (All protocol activities)· Middletown, NJMemorial Sloan Kettering Bergen (All protocol activities)· Montvale, NJMemorial Sloan Kettering Commack (All protocol activities)· Commack, NYMemorial Sloan Kettering Westchester (All protocol activities)· Harrison, NYColumbia University· New York, NY
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