A Phase II Study Using Rituximab Plus Venetoclax in the Front Line Treatment of Marginal Zone Lymphoma

  • STATUS
    Recruiting
  • End date
    Jun 28, 2023
  • participants needed
    47
  • sponsor
    Memorial Sloan Kettering Cancer Center
Updated on 28 July 2022

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.

Details
Condition Marginal Zone Lymphoma
Treatment Rituximab, venetoclax
Clinical Study IdentifierNCT04416451
SponsorMemorial Sloan Kettering Cancer Center
Last Modified on28 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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
institutional normal (by Cockcroft-Gault estimate or 12-24h creatinine
°OR Creatinine clearance >60 mL/min for patients with creatinine levels above
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 Criteria

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
undetectable
°Patients with Hep B core ab positivity are allowed provided Hep B PCR is
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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