Randomized, Phase III Study of Early Intervention with Venetoclax and Obinutuzumab Versus Delayed Therapy with Venetoclax and Obinutuzumab in Newly Diagnosed Asymptomatic High-Risk Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL

Contact:

NCT Number:

Protocol:

AAAU8932

Study Status:

Active/Enrolling

Population:

Adult

Phase:

III

This study is being done to answer the following question about treatment with venetoclax and obinutuzumab (called V-O) in patients with high-risk chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL): Can starting treatment early (before symptoms begin) help patients live longer than the usual approach of waiting to start treatment once symptoms appear? This study will help to find out if this approach is better or worse than the usual approach for patients with high-risk CLL or SLL. The usual approach is the care most people get. For high-risk CLL or SLL, the usual approach is “watch and wait”. This means doctors closely watch a cancer and start treatment after symptoms appear. Researchers also hope to find out how this difference affects patients' quality of life.

Are you Eligible? (Inclusion Criteria)

  • Are you 18 years of age or older? Have you been diagnosed with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) within the past 12 months? Are you able to come to clinic for regularly scheduled treatment and evaluation?

Specialty Area(s)

Leukemia, Chronic Lymphocytic Leukemia, Immunotherapy

Principal Investigator

Trial Location(s)

CUIMC/Herbert Irving Pavilion
161 Fort Washington Avenue
New York, NY 10032