NCT02257242

Vincristine Sulfate Liposome Injection (Marqibo®), Bendamustine and Rituximab-Phase I Trial in Indolent B-cell Lymphoma

BrUOG 326: A Phase I Dose-Escalation Study of Vincristine Sulfate Liposome Injection (Marqibo®) in Combination With Bendamustine and Rituximab (BRiM) in Indolent Non-Hodgkin Lymphoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Brown University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates addition of Vincristine Sulfate Liposome Injection (Marqibo®) to the standard regimen of Bendamustine and Rituximab in adult patients with indolent B-cell lymphoma. This is a dose-escalation study.

Detailed description

Bendamustine-rituximab is a standard chemotherapy regimen for treatment of many indolent B-cell lymphomas, but most patients experience a recurrence of the lymphoma. Vincristine sulfate has been a traditional component of chemotherapy regimens in non-Hodgkin lymphoma and it is possible that adding it to the bendamustine-rituximab regimen might provide a better quality of remissions or longer duration of remissions with acceptable toxicity. This is a phase 1, single-center, open-label, single-arm trial in patients with indolent B-cell non-Hodgkin lymphoma otherwise appropriate for bendamustine-rituximab as initial or subsequent line of therapy. Patients will receive the of rituximab and bendamustine in combination with escalating doses of vincristine sulfate liposome injection (Marqibo®). The objective of this study is to assess safety of this combination by establishing the maximum tolerated dose of vincristine sulfate liposome injection (Marqibo®) in the combination.

Conditions

• Lymphoma, Non-Hodgkin
• Lymphoma, Follicular
• Lymphoma, Mantle-Cell
• Lymphoma, Small-Cell
• Waldenstrom Macroglobulinemia
• Lymphoma, B-Cell, Marginal Zone

Interventions

Type	Name	Description
DRUG	Rituximab	375 mg/m2 I.V. on Day 1 of each cycle
DRUG	Bendamustine	90 mg/m2 I.V. on Day 1 and 2 of each cycle
DRUG	Vincristine sulfate liposome injection	Dose per dose escalation protocol, I.V. on Day 2 of each cycle

Timeline

• Start date: 2017-05-10
• Primary completion: 2020-08-22
• Completion: 2020-11-18
• First posted: 2014-10-06
• Last updated: 2023-02-09
• Results posted: 2023-02-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study