Phase 2 Study of Zevalin Versus Zevalin and Motexafin Gadolinium in Patients With Rituximab-Refractory Low-grade or Follicular B-cell Non-Hodgkin's Lymphoma

Part of paid clinical trials in Berkeley, California.

Sponsor
Spectrum Pharmaceuticals, Inc
Study ID
NCT01549886
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Y-90-Zevalin — DRUG
    Day 8 - Y-90-Zevalin 0.4 mCi/kg 10-minute intravenous push
  • Moxtezafin Gadolinium — DRUG
    Day 1-4 Motexafin gadolinium 5 mg/kg intravenously once daily, followed in one hour (Day 1 only) by Day 1 Rituximab 250 mg/m\^2 intravenous infusion. Day 8-11 Motexafin gadolinium 5 mg/kg intravenously once daily
  • Rituximab — DRUG
    Day 1 and Day 8: Rituximab 250 mg/m\^2 intravenous infusion

Study Details

The objectives of this study are to evaluate the efficacy and safety of the Zevalin regimen compared to Zevalin and motexafin gadolinium in patients with rituximab-refractory, low-grade or follicular Non-Hodgkin's Lymphoma (NHL). Effectiveness of the experimental regimen assessed by complete response rate within 6 months of study entry (primary endpoint), complete response rate within 3 months of study entry, and overall response rate within 6 month of study entry.

Key Dates

First listed
Mar 9, 2012
Start date
Nov 30, 2011
Status verified
Sep 2021
Primary completion
Jun 30, 2014
Completion
May 31, 2015

Study Design

Enrollment
5 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: MGD + Rituximab + Y-90-Zevalin
    Moxtezafin Gadolinium: Day 1-4 Motexafin gadolinium 5 mg/kg intravenously once daily, followed in one hour (Day 1 only) by Day 1 Rituximab 250 mg/m\^2 intravenous infusion. Day 8-11 Motexafin gadolinium 5 mg/kg intravenously once daily, followed in one hour (Day 8 only) by Day 8 Rituximab 250 mg/m\^2 intravenous infusion, followed 4 hours later by Y-90-Zevalin 0.4 millicurie / kilogram (mCi/kg) 10-minute intravenous push (0.3 mCi/kg in patients with a platelet count in 100,000/μL to 149,000/μL.
  • Active Comparator: Rituximab + Y-90-Zevalin
    Day 1 Rituximab 250 mg/m\^2 intravenous infusion. Day 8 Rituximab 250 mg/m\^2 intravenous infusion, followed 4 hours later by Y-90-Zevalin 0.4 mCi/kg 10-minute intravenous push

Primary Outcome Measure

Complete Response Rate (CR) [ Time Frame: 6 Months ]

Locations (9)

FacilityCityStateZIPSite coordinators
Alta Bates Summit Medical Center-HerrickBerkeleyCalifornia94704-
Providence Saint Joseph Medical CenterBurbankCalifornia91505-
Halifax Health- Center for OncologyDaytona BeachFlorida32114-
Rush University Medical CenterChicagoIllinois60612-
Loyola University ChicagoMaywoodIllinois60153-
Oncology SpecialistsPark RidgeIllinois60068-
University of Massachusetts - WorcesterWorcesterMassachusetts01655-
Hackensack Medical CenterHackensackNew Jersey07601-
West Virginia University, WVU HealthcareMorgantownWest Virginia26506-

Find similar trials in Berkeley, CA

By research site
Alta Bates Summit Medical Center-Herrick· Berkeley, CAProvidence Saint Joseph Medical Center· Burbank, CAHalifax Health- Center for Oncology· Daytona Beach, FLRush University Medical Center· Chicago, ILLoyola University Chicago· Maywood, ILOncology Specialists· Park Ridge, IL

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