S1925: Phase III Study of Newly Diagnosed Asymptomatic High-Risk Patents with CLL/SLL - Clinical Trial
What is the Purpose of this Study?
We are doing this study to compare the early treatment (before you have cancer symptoms) of Venetoclax and Obitnutuzumab (V-O) to the usual treatment of V-O after you have cancer symptoms. This study will help doctors figure out if early treatment is better, the same, or worse than the usual approach of waiting until the patient has cancer symptoms before starting treatment.
What is the Condition Being Studied?
Newly Diagnosed Asymptomatic High-Risk Patients with Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL)
Who Can Participate in the Study?
Adults ages 18+ who:
- Are asymptomatic, high-risk patients with newly diagnosed CLL or SLL
- Have not received any current or previous treatment for CLL or SLL, including investigational drugs
- Do not have a bleeding disorder
For more information about who can join this study, please contact the study team at 919-684-8964.
Age Group
Adults
What is Involved?
If you choose to join this study, you will get an assignment to 1 of 2 treatment groups:
- Group1 (Delayed Treatment/Usual Approach) will get the usual drugs to treat this type of cancer. You will start the treatment at the usual time when you have the cancer symptoms. The drugs are given in cycles that last 28 days.
- Group 2 (Early Treatment) will get the same drugs as patients in Group 1. You will start the treatment right away, which will be before you have any cancer symptoms.
Participants in both groups will:
- Fill out questionnaires
- Have blood draws
- Have bone marrow samples taken
- Have imaging scans (CT)
Study Details
Full Title
SWOG S1925: 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/SLL): EVOLVE CLL/SLL Study
Principal Investigator
Hematologic Oncologist
Protocol Number
IRB:
PRO00110390
NCT:
NCT04269902
Phase
Phase
III
ClinicalTrials.gov
View on ClinicalTrials.gov
Enrollment Status
Open for Enrollment