A Phase II Study Using Rituximab Plus Venetoclax in the Front Line Treatment of Marginal Zone Lymphoma
The purpose of this study is to see if the combination of rituximab and venetoclax is effective in treating participants with untreated Marginal Zone Lymphoma (MZL). The names of the study drugs involved in this study are: * Venetoclax (a type of inhibitor) * Rituximab (a type of antibody)
• Participants must have histologically confirmed Marginal Zone Lymphoma
• Patients must have measurable disease as defined by at least one lymph node ≥1.5 cm or spleen \> 13 cm
• Patients with intestinal MALT lymphoma must have disease that is detectable by EGD or colonoscopy with biopsy
• Patients with gastric MALT lymphoma must be h. pylori negative. Patients who are h. pylori positive are allowed if they have failed a trial of h. pylori eradication
• Patients with gastric MALT lymphoma who are h. pylori negative or who relapsed/refractory disease after h. pylori eradication must be ineligible form have refused or failed gastric radiation therapy
• Age ≥18 years
• ECOG performance status ≤1
• Life expectancy of greater than 2 years
• Participants must meet the following organ and marrow function as defined below:
‣ Hemoglobin ≥8.0 g/dL
⁃ absolute neutrophil count ≥1,000 cells/mcL (In the event of documented bone marrow involvement, ANC must be ≥1500 cells/mcL)
⁃ platelets ≥50,000 cells/mm3
⁃ total bilirubin \< 1.5 x institutional upper limit of normal (ULN) (In patients with Gilberts disease or documented liver involvement, total bilirubin \< 3 X ULN will be allowed)
⁃ AST(SGOT)/ALT(SGPT) \< 3 × institutional ULN unless elevation is caused by liver involvement with MZL
⁃ Creatinine within institutional ULN OR creatinine clearance \>60mL/min for patients with creatinine levels above institutional normal (by Cockcroft-Gault estimate or 12-24h creatinine clearance measurements)
• Ability to understand and the willingness to sign a written informed consent document
• Patient must be able to swallow pills
• HIV-positive patients on combination antiretroviral therapy are eligible if their HIV is under adequate control with an antiretroviral regimen that has been stable for \> 4 weeks, as long as the CD4 count is \>300. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated
• Patients with Hepatitis B surface antibody serum positivity due to poor immunization, as well as those with Hepatitis B core antibody positivity with negative PCR on antiviral therapy will be eligible