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

Part of paid clinical trials in Duarte, California.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT04416451
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Marginal Zone Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    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.
  • Venetoclax — DRUG
    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.

Study Details

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.

Key Dates

Start date
May 4, 2021
Status verified
Jul 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
6 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Rituximab and Venetoclax
    Patients will be treated with an Induction phase of rituximab 375 mg/m2 weekly for 4 weeks. Patients will undergo restaging imaging after the last of 4 weekly rituximab doses and before beginning venetoclax. Based on post-rituximab restaging studies, patients will be risk-stratified for risk of Tumor Lysis Syndrome (TLS) and treated in the appropriate setting with TLS prophylaxis per institutional TLS guide lines starting at week 5. Oral venetoclax will follow a ramp-up dosing schedule and will be taken daily after 4 weeks of rituximab therapy. Following the 4-week ramped-up phase of venetoclax, patients will begin their target dose of venetoclax and continue for a maximum of 24 months. 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. Venetoclax may be continued after this period if patient has not achieved a complete remission

Primary Outcome Measure

complete response rate (CRR) [ Time Frame: 2 years ]

Locations (8)

FacilityCityStateZIPSite coordinators
City of Hope Cancer Center (Data collection only)DuarteCalifornia91010-
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)Basking RidgeNew Jersey07920-
Memorial Sloan Kettering Monmouth (All protocol activities)MiddletownNew Jersey07748-
Memorial Sloan Kettering Bergen (All protocol Activities)MontvaleNew Jersey07645-
Memorial Sloan Kettering Commack (All Protocol Activities)CommackNew York11725-
Memorial Sloan Kettering Westchester (All Protocol Activities)HarrisonNew York10604-
Memorial Sloan Kettering Cancer Center (All Protocol Activities)New YorkNew York10065-
Memorial Sloan Kettering Rockville Centre (All Protocol Activities)Rockville CentreNew York11570-

Find similar trials in Duarte, CA

By research site
City of Hope Cancer Center (Data collection only)· Duarte, CAMemorial Sloan Kettering Basking Ridge (All Protocol Activities)· Basking Ridge, NJMemorial Sloan Kettering Monmouth (All protocol activities)· Middletown, NJMemorial Sloan Kettering Bergen (All protocol Activities)· Montvale, NJMemorial Sloan Kettering Commack (All Protocol Activities)· Commack, NYMemorial Sloan Kettering Westchester (All Protocol Activities)· Harrison, NY

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