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

NCT02257242 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2023-02-09

Study results available
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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.

Conditions

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

Interventions

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

Sponsors & Collaborators

  • Spectrum Pharmaceuticals, Inc

    collaborator INDUSTRY

  • Rhode Island Hospital

    collaborator OTHER

  • The Miriam Hospital

    collaborator OTHER

  • Brown University

    lead OTHER

Principal Investigators

  • Adam J Olszewski, MD · Rhode Island Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-10
Primary Completion
2020-08-22
Completion
2020-11-18
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02257242 on ClinicalTrials.gov