Rituximab + High-Dose Methylprednisolone Debulking Prior to Venetoclax for CLL & SLL Patients (NCT04981912) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Rituximab + High-Dose Methylprednisolone Debulking Prior to Venetoclax for CLL & SLL Patients
United States4 participantsStarted 2021-09-02
Plain-language 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.
Who can participate
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Inclusion criteria
✓. Subjects must be age 18 or older.
✓. Both men and women of all races and ethnic groups are eligible for this trial.
✓. Ability to understand and willingness to sign a written informed consent.
✓. Diagnosis: CLL or SLL, as documented in the medical record
✓. Disease Status/ Prior Therapy:
✓. Has recovered from the toxic effects of prior therapy to their clinical baseline.
✓. Women of child-bearing potential (not postmenopausal for at least one year or not surgically incapable of bearing children) must agree to not become pregnant for the duration of the study. Both men and women must agree to use a barrier method of contraception for the duration of the study and until 5 half-lives after the final dose of venetoclax (approximately 1 week), and at least 5 half-lives of final dose of Rituximab.
✓. ECOG performance status of 0-2
Exclusion criteria
✕. Subject is known to be positive for HIV. (HIV testing is not required.)
✕. Evidence of other clinically significant uncontrolled condition(s) including, but not limited to:
What they're measuring
1
Percentage of Patients That Have a Decrease in Tumor Burden From Medium or High to Low
✕. Treatment with any of the following within 7 days prior to the first dose of venetoclax:
✕. Administration or consumption of any of the following within 3 days prior to the first dose of venetoclax:
✕. Prior CLL therapy:
✕. History of severe allergic or anaphylactic reactions to monoclonal antibody therapy
✕. Known hypersensitivity to any of the study drugs
✕. History of other malignancy that could affect compliance with the protocol or interpretation of results (example: patients with a history of curatively treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix are generally eligible. Patients with a malignancy that has been treated, but not with curative intent, will also be excluded, unless the malignancy has been in remission without treatment for 2 years prior to enrollment.)