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)

Protocol: SWOG – S1925

SCHEMA S1925

Please Note:  Below is partial eligibility, for full eligibility requirement’s,  please contact GHCI Research Department at (810) 762-8181, (810) 762-8079 and/or (810) 762-8038. Thank you!

Eligibility:

1. Participants must have a confirmed diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
2. Participants must have CLL-International Prognostic Index (CLL-IPI) Score ≥ 4 and/or complex cytogenetics (defined as 3+ chromosomal abnormalities).
3. Cytogenetic and FISH analyses must be completed at a CLIA-approved laboratory within 12 months prior to registration. FISH panel should use probes to detect for abnormalities in chromosomes 13q, 12, 11q, and 17p.
4. TP53 mutation status (if completed) must be obtained within 12 months prior to registration.
5. IgVH mutational status must be obtained prior to registration (at any time prior to registration).
6. Serum beta-2 microglobulin level must be obtained within 28 days prior to registration.
7. Treatment with high dose corticosteroids and/or intravenous immunoglobulin for autoimmune complications of CLL must be complete at least 4 weeks prior to enrollment.
8. Steroids used for treatment of conditions other than CLL/SLL must be at a dose of at most 20 mg/day of prednisone or equivalent corticosteroid at the time of registration.
9. Prior therapy with anti CD20 monoclonal antibodies is not allowed.
10. Participants must not have received or be currently receiving any prior CLLdirected therapy, including non-protocol-related therapy, anti-cancer immunotherapy, experimental therapy, or radiotherapy.
11. Participants must not be receiving or planning to receive any other investigational agents before completing protocol therapy.
12. Must be at least 18 years of age.
13. ECOG Performance Status 0-2.
14. Participants with history of malignancy are allowed providing the cancer has not required active treatment within 2 years prior to registration (hormonal therapy is permissible). The following exceptions are permissible: basal cell, squamous cell skin, or non-melanomatous skin cancer, in situ cervical cancer, superficial bladder cancer not treated with intravesical chemotherapy or BCG within 6 months, localized prostate cancer requiring no more than chronic hormonal therapy, or localized breast cancer requiring no more than chronic hormonal therapy.