Rituximab Plus Venetoclax in Front Line Marginal Zone Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorGottfried von Keudell, MD PhD
About this trial
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)
Eligibility criteria
Qualifiers
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
Disqualifiers
Patients who had prior systemic therapy including rituximab
Palliative radiotherapy (RT) is allowed, but must be completed at least 1 week prior to treatment on this study, and prior to any baseline imaging studies or biopsies. Patients must meet criteria for measurable/assessable disease as outlined above after completion of RT.
Prior RT for gastric MALT is allowed, but must be completed at least 1 week prior to treatment on this study, and prior to any 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
Trial design
Treatments tested in this trial
- Venetoclax
- Rituximab
Treatment groups
33 Participants
are divided into 1 treatment groupSponsors and collaborators
Gottfried von Keudell, MD PhD
Lead sponsor
Beth Israel Deaconess Medical Center
Sponsor institution
AbbVie
Collaborator
Source ClinicalTrials.gov