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

Part of paid clinical trials in Providence, Rhode Island.

Sponsor
Brown University
Study ID
NCT02257242
Phase
PHASE1
Status
Completed

Conditions

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

Eligibility Criteria

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

Interventions

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

Study Details

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.

Key Dates

Start date
May 10, 2017
Status verified
May 2022
Primary completion
Aug 22, 2020
Completion
Nov 18, 2020

Study Design

Enrollment
11 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Vincristine sulfate liposome injection 1.8 mg/m^2
    Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
  • Experimental: Vincristine sulfate liposome injection 1.95 mg/m^2
    Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
  • Experimental: Vincristine sulfate liposome injection 1.98 mg/m^2
    Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
  • Experimental: Vincristine sulfate liposome injection 2.04 mg/m^2
    Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
  • Experimental: Vincristine sulfate liposome injection 2.10 mg/m^2
    Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
  • Experimental: Vincristine sulfate liposome injection 2.14 mg/m^2
    Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
  • Experimental: Vincristine sulfate liposome injection 2.19 mg/m^2
    Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
  • Experimental: Vincristine sulfate liposome injection 2.22 mg/m^2
    Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
  • Experimental: Vincristine sulfate liposome injection 2.24 mg/m^2
    Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.

Primary Outcome Measure

Maximum Tolerated Dose [ Time Frame: Up to 6 cycles of treatment (approximately 6 months) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Rhode Island Hospital and The Miriam HospitalProvidenceRhode Island02903-

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By research site
Rhode Island Hospital and The Miriam Hospital· Providence, RI

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