Status:
ACTIVE_NOT_RECRUITING
A Phase II Study Using Rituximab Plus Venetoclax in the Front Line Treatment of Marginal Zone Lymphoma
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
AbbVie
Conditions:
Marginal Zone Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study will help researchers understand how effective the combination of venetoclax and rituximab is in treating MZL in people who have not received a previous treatment for their cancer.
Eligibility Criteria
Inclusion
- Age greater than or equal to 18 years
- 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 have relapsed/refractory disease after h. pylori eradication must be ineligible for, have refused or failed gastric radiation therapy
- ECOG performance status ≤ 1
- Life expectancy of greater than 2 years
- Patients must have normal organ function as defined below:
- Platelet count ≥ 50,000 cells/mm\^3
- Hemoglobin ≥ 8.0 g/dL
- Absolute neutrophil count ≥ 1000 cells/mcL. If there is documented bone marrow involvement, ANC must be \>/= 500 cells/mcL
- Total bilirubin \< 1.5 x upper normal institutional limits. In patients with Gilbert's disease or documented liver involvement, total bilirubin up to 3x ULN will be allowed
- AST(SGOT)/ALT(SGPT) \<3 x institutional upper limit of normal unless elevation is caused by liver involvement with MZL
- AST(SGOT)/ALT(SGPT) \<3 x institutional upper limit of normal unless elevation is caused by liver involvement with MZL
- °OR Creatinine clearance \>60 mL/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.
- 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 prior immunization, as well as those with Hepatitis B core antibody positivity with negative PCR on antiviral therapy will be eligible.
Exclusion
- Patients who have had prior systemic therapy, including rituximab
- Patients who have had prior radiation therapy, with the following exception:
- °Palliative radiotherapy RT is allowed but must be completed at least 1 week prior to treatment on this study, and prior baseline imaging studies or biopsies. Patients must meet criteria for measurable/assessable disease as outlined above after completion of RT
- Prior treatment with ibrutinib or other BTK inhibitor
- Patients with h. pylori-associated gastric MALT or stage I/II MZL will be excluded unless they are deemed to be unfit for radiation therapy with curative intent.
- Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- °Patients with Hep B core ab positivity are allowed provided Hep B PCR is undetectable
- Lactating or pregnant women
- Participants unwilling to adhere to institutional guidelines for highly effective contraception for 12 months after the last dose of rituximab
- Patients who received moderate or strong CYP3A inhibitors (such as fluconazole, ketoconazole, and clarithromycin) within 7 days prior to the first dose of venetoclax.
- Patients who received moderate or strong CYP3A inducers (such as rifampin, carbamazepine, phenytoin, St. John's Wort) within 7 days prior to the first dose of venetoclax.
Key Trial Info
Start Date :
May 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2026
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04416451
Start Date
May 4 2021
End Date
June 1 2026
Last Update
July 2 2025
Active Locations (8)
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1
City of Hope Cancer Center (Data collection only)
Duarte, California, United States, 91010
2
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
3
Memorial Sloan Kettering Monmouth (All protocol activities)
Middletown, New Jersey, United States, 07748
4
Memorial Sloan Kettering Bergen (All protocol Activities)
Montvale, New Jersey, United States, 07645