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.
Who Can Participate?
Eligibility
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
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
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.
- Fill out questionnaires
- Have blood draws
- Have bone marrow samples taken
- Have imaging scans (CT)
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
Yes
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
Danielle
Brander
Protocol Number
PRO00110390
NCT ID
NCT04269902
Phase
III
Enrollment Status
Open to Enrollment