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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Venetoclax
DrugB-cell lymphoma inhibitor, tablets taken orally per protocol.
Rituximab
DrugAnti-CD20 monoclonal antibody, 10mL or 50 mL single-use vials, via intravenous (into the vein) infusion per protocol.
Treatment groups
33 Participants
are divided into 1 treatment groupGroup A: Rituximab + VenetoclaxExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Complete Response Rate (CRR)
Complete Response (CR) rate is defined as the proportion of participants achieving CR during study treatment. CR is defined based on RECIL criteria.
Time frame
Up to 24 monthsSecondary outcomes
1
Overall response rate (ORR)
ORR will be measured as the proportion of participants that achieve a PR or CR per RECIL criteria.
Time frame
Up to 24 months2
Partial Remission (PR) Rate
Partial remission (PR) rate is defined as the proportion of participants achieving partial remission RECIL criteria.
Time frame
Up to 24 months3
Median Progression Free Survival (PFS)
PFS based on Kaplan-Meier methodology will be measured from the time the participant initiates treatment until the first occurrence of documented progression of disease or death from any cause, censored for participants alive without progression.
Time frame
Up to 24 months4
Median Overall Survival (OS)
OS based on Kaplan-Meier methodology will be measured from the time the participant initiates treatment until death from any cause, censored for participants alive.
Time frame
Up to 36 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Gottfried von Keudell, MD PhD
Lead sponsor
Beth Israel Deaconess Medical Center
Sponsor institution
AbbVie
Collaborator
Source ClinicalTrials.gov