Testing Early Treatment for Patients With High-Risk Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL), EVOLVE CLL/SLL Study

This phase III trial compares early treatment with venetoclax and obinutuzumab versus delayed treatment with venetoclax and obinutuzumab in patients with newly diagnosed high-risk chronic lymphocytic leukemia or small lymphocytic lymphoma. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Immunotherapy with monoclonal antibodies, such as obinutuzumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow

Trial Details

NCT ID
NCT04269902
Phase
PHASE3
Sponsor
National Cancer Institute (NCI)
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Biospecimen Collection
  • Bone Marrow Aspiration
  • Bone Marrow Biopsy
  • Computed Tomography
  • Obinutuzumab
  • Questionnaire Administration
Locations (sample)
  • Birmingham, Alabama, United States|33.52066,-86.80249
  • Anchorage, Alaska, United States|61.21806,-149.90028
  • Anchorage, Alaska, United States|61.21806,-149.90028
  • Phoenix, Arizona, United States|33.44838,-112.07404
  • Fort Smith, Arkansas, United States|35.38592,-94.39855

Key Eligibility Criteria

  • Participants must have a confirmed diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) (collectively referred to as…
  • Participants must have CLL-International Prognostic Index (CLL-IPI) score \>= 4 and/or complex cytogenetics (defined as 3+ chromosomal abnormalities)
  • Cytogenetic AND/OR FISH analyses must be completed at a Clinical Laboratory Improvement Act (CLIA)-approved (or laboratories accredited under Accre…
  • TP53 gene mutation analysis performed at any CLIA-approved (or laboratories accredited under Accreditation Canada Diagnostics) lab (if completed) m…

For full eligibility, visit ClinicalTrials.gov.

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