drugset
drugset / Trial / NCT02257242

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

NCT02257242 ↗

Phase 1 Completed 11 enrolled Brown University Rhode Island Hospital · collabSpectrum Pharmaceuticals, Inc · collabThe Miriam Hospital · collab
RandomizedSequentialOpen-labelTreatment

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.

Timeline

Start
2017-05-10
Primary completion
2020-08-22
Completion
2020-11-18

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Vincristine Small molecule 1.8 mg/m2 Intravenous
Subject Vincristine Small molecule 1.95 mg/m2 Intravenous
Subject Vincristine Small molecule 1.98 mg/m2 Intravenous
Subject Vincristine Small molecule 2.04 mg/m2 Intravenous
Subject Vincristine Small molecule 2.1 mg/m2 Intravenous
Subject Vincristine Small molecule 2.14 mg/m2 Intravenous
Subject Vincristine Small molecule 2.19 mg/m2 Intravenous
Subject Vincristine Small molecule 2.22 mg/m2 Intravenous
Subject Vincristine Small molecule 2.24 mg/m2 Intravenous
Background Bendamustine Small molecule 90 mg/m2 Intravenous
Background Rituximab Monoclonal antibody 375 mg/m2 Intravenous

Indications

Waldenstrom macroglobulinemia follicular lymphoma mantle cell lymphoma marginal zone lymphoma