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

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

6

Participants

Timeline

Start Date

May 4, 2021

Primary Completion Date

June 30, 2026

Study Completion Date

June 30, 2026

Conditions
Marginal Zone Lymphoma
Interventions
DRUG

Rituximab

Induction:Rituximab will be administered per institutional guidelines once per week for 4 weeks at a dose of 375 mg/m\^2. Maintenance: In addition, patients will receive rituximab 375 mg/m2 starting on day 1 of the maintenance phase and repeated once every 3 months for 12 months (for a total of 4 infusions). On days when venetoclax and rituximab will both be administered, patients will take venetoclax prior to administration of rituximab.

DRUG

Venetoclax

"Induction: Starting one week after the last induction dose of rituximab (approximately week 5), venetoclax will be administered orally at a flat dose of 100 mg daily and escalating each week to a target dose of 800 mg daily on the following schedule:~* Week 1: 100 mg~* Week 2: 200 mg~* Week 3: 400 mg~* Week 4: 800 mg Maintenance: Following the 4-week induction phase ramp-up of venetoclax, patients will begin their target dose of 800 mg venetoclax daily and continue this dose during the 24- month maintenance treatment phase. On days when venetoclax and rituximab will both be administered, patients will take venetoclax prior to administration of rituximab."

Trial Locations (8)

10065

Memorial Sloan Kettering Cancer Center (All Protocol Activities), New York

10604

Memorial Sloan Kettering Westchester (All Protocol Activities), Harrison

11570

Memorial Sloan Kettering Rockville Centre (All Protocol Activities), Rockville Centre

11725

Memorial Sloan Kettering Commack (All Protocol Activities), Commack

91010

City of Hope Cancer Center (Data collection only), Duarte

07920

Memorial Sloan Kettering Basking Ridge (All Protocol Activities), Basking Ridge

07748

Memorial Sloan Kettering Monmouth (All protocol activities), Middletown

07645

Memorial Sloan Kettering Bergen (All protocol Activities), Montvale

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

AbbVie

INDUSTRY

lead

Memorial Sloan Kettering Cancer Center

OTHER