Rituximab or Zevalin - Efficacy Trial of Therapeutic Alternatives (RoZetta)

Part of paid clinical trials in Sun City, Arizona.

Sponsor
Spectrum Pharmaceuticals, Inc
Study ID
NCT01662102
Phase
PHASE3
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Zevalin — DRUG
    Zevalin administered intravenously.
  • Rituximab — DRUG
    Rituximab administered intravenously.

Study Details

The purpose of this study is to evaluate the effect of consolidation treatment Zevalin® versus maintenance treatment with Rituxan® on progression-free survival (PFS) following response induction with chemotherapy plus rituximab in previously untreated participants with follicular lymphoma.

Key Dates

Start date
Dec 11, 2012
Status verified
Sep 2021
Primary completion
Mar 5, 2013
Completion
Mar 5, 2013

Study Design

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

Arms

  • Experimental: Zevalin Regimen Consolidation (Group A)
    90Y-Ibritumomab tiuxetan administered 8 to 12 weeks after the last chemotherapy infusion. Each participant randomized to this treatment group was to receive a therapeutic dose of 14.8 MBq/kg (0.4 mCi/kg of total body weight) of 90Y ibritumomab tiuxetan (maximum 1,184 MBq or 32 mCi). Participants with a pre-treatment platelet count between 100 and 149 x10\^9/L were to receive 0.3 mCi/Kg 90Y-ibritumomab tiuxetan. (Body weight ≤80 kg: 14.8 MBq \[0.4 mCi\] yttrium-90/kg and Body weight \>80 kg: 1,184 MBq \[32 mCi\] maximum dose). The 90Y ibritumomab tiuxetan regimen is as follows: Day 1 rituximab (250 mg/m\^2); Day 7,8, or 9 rituximab (250 mg/m\^2) followed by 90Y ibritumomab tiuxetan within 4 hours of the end of the rituximab infusion. (Maximum duration of study was up to approximately 2.7 months).
  • Active Comparator: Rituximab Maintenance (Group B)
    Participants were to receive 375 mg/m\^2 of rituximab, administered by intravenous (I.V.) infusion every 8 weeks, starting 8 to 12 weeks after the last R-chemotherapy cycle. (Maximum duration of study was up to approximately 2.7 months).

Primary Outcome Measure

Progression Free Survival [ Time Frame: Up to approximately 2.7 months ]

Locations (5)

FacilityCityStateZIPSite coordinators
21st Century OncologySun CityArizona85351-
Northeast Georgia Cancer CareAthensGeorgia30607-
Illinois Cancer SpecialistsNilesIllinois60714-
Park Nicollet InstituteSaint Louis ParkMinnesota55426-
Charleston Area Medical CenterCharlestonWest Virginia25304-

Find similar trials in Sun City, AZ

By research site
21st Century Oncology· Sun City, AZNortheast Georgia Cancer Care· Athens, GAIllinois Cancer Specialists· Niles, ILPark Nicollet Institute· Saint Louis Park, MNCharleston Area Medical Center· Charleston, WV

Related Studies