ZAR2007: R-CHOP in Folicular Lymphoma Patients no Treated Previously. Consolidation With 90Y Ibritumomab Tiuxetan (Zevalin®) Versus Maintenance Treatment With Rituximab (MabThera®)

Sponsor
PETHEMA Foundation
Study ID
NCT00662948
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Rituximab — DRUG
    375 mg/m2 every 8 weeks during 24 months
  • Ibritumomab tiuxetan — DRUG
    One dose of 90Y Ibritumomab tiuxetan, 0,4 mCi/Kg

Study Details

After conventional induction treatment with R-CHOP (Rituximab, cyclophosphamide, adriamycin, vincristine and prednisone) the patients are randomized to: A: Consolidation with one dose of 90Y Ibritumomab tiuxetan (Zevalin®) 0,4 mCi/Kg B: Maintenance with 375 mg/m2 of Rituximab every 8 weeks during 24 months

Key Dates

Start date
Dec 31, 2008
Status verified
Apr 2020
Primary completion
Oct 31, 2014
Completion
Oct 30, 2017

Study Design

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

Arms

  • Experimental: A
    Consolidation with one dose of 90Y Ibritumomab tiuxetan (Zevalin®) 0,4 mCi/Kg
  • Active Comparator: B
    Maintenance with 375 mg/m2 of Rituximab every 8 weeks during 24 months

Primary Outcome Measure

Progression free survival [ Time Frame: 2 years ]

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