Protocol: SWOG – S1925
Please Note: Below is a brief partial list of eligibility, please contact GHCI Research Department at (810) 762-8181, (810) 762-8079 and/or (810) 762-8038 to discuss full eligibility requirements.
- Participants must have a confirmed diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
- Participants must have CLL-International Prognostic Index (CLL-IPI) Score ≥ 4 and/or complex cytogenetics (defined as 3+ chromosomal abnormalities).
- 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.
- TP53 mutation status (if completed) must be obtained within 12 months prior to registration.
- IgVH mutational status must be obtained prior to registration (at any time prior to registration).
- Serum beta-2 microglobulin level must be obtained within 28 days prior to registration.
- Treatment with high dose corticosteroids and/or intravenous immunoglobulin for autoimmune complications of CLL must be complete at least 4 weeks prior to enrollment.
- 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.
- Prior therapy with anti CD20 monoclonal antibodies is not allowed.
- 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.
- Participants must not be receiving or planning to receive any other investigational agents before completing protocol therapy.
- Must be at least 18 years of age.
- ECOG Performance Status 0-2.
- 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.