Rituximab + High-Dose Methylprednisolone Debulking Prior to Venetoclax for CLL & SLL Patients
Status:
Not yet recruiting
Trial end date:
2026-07-22
Target enrollment:
Participant gender:
Summary
The purpose of the study is to investigate whether the combination of rituximab and high dose
methylprednisolone can be given together, can reduce the amount of cancer cells that are
present prior to starting venetoclax, and therefore make it safer to take venetoclax.
Patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic
lymphoma (SLL) will be treated in this study. Subjects will be assessed for their risk of
tumor lysis syndrome (TLS), a potentially serious side effect associated with venetoclax and
rituxan. TLS is caused by the fast breakdown of cancer cells. TLS can lead to kidney failure
or abnormal heart rhythm. Depending on their TLS risk, patients will be assigned to one of
two treatment arms. Patients who are at high risk for TLS at baseline will receive
HDMP/Rituximab for 1 cycle before beginning venetoclax. Patients who are at low risk for TLS
at baseline will not receive HDMP/Rituximab and will instead start directly with venetoclax.
Once the proper dose of venetoclax is reached, both arms will continue venetoclax for up to 2
years and receive rituximab for 5 cycles. The purpose is to determine if HDMP/Rituximab prior
to venetoclax is efficient at reducing tumor burden and lowering the risk of developing TLS.
Although all of these drugs are approved by the FDA for the treatment of patients with CLL or
SLL, and although the combination of rituximab and venetoclax is approved by the FDA for the
treatment of patients with CLL or SLL, the combination and dosing schedule in this trial are
considered experimental.