Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Treating Patients With Previously Untreated Marginal Zone Lymphoma

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT00453102
Phase
PHASE2
Status
Completed

Conditions

  • Marginal Zone Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    IV Infusion of 250mg/m² of Rituximab Within 4 hours on Days 1, 7, 8, 9 0.4 millicuries (mCi)/kilogram (kg) (14.8 megabecquerels (MBq)/kilogram (kg)) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³
  • Ibritumomab Tiuxetan — DRUG
    IV injection of Y-90 Zevalin® over 10 minutes on Days 1, 7, 8, 9: 0.4 mCi/kg (14.8 MBq/kg) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³

Study Details

Zevalin may be an effective therapy for newly diagnosed marginal zone lymphoma (MZL).

Key Dates

Start date
Feb 28, 2006
Status verified
Nov 2015
Primary completion
Feb 28, 2015
Completion
Feb 28, 2015

Study Design

Enrollment
18 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Zevalin + Rituximab
    Ibritumomab Tiuxetan (Zevalin) + Rituximab

Primary Outcome Measure

Overall Rate of Response (ORR) in Participants Receiving Protocol Therapy. [ Time Frame: 12 weeks post-therapy ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Miami Sylvester Comprehensive Cancer Center - MiamiMiamiFlorida33136-

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University of Miami Sylvester Comprehensive Cancer Center - Miami· Miami, FL

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