Ibritumomab Tiuxetan for Treatment of Non-Follicular CD20+ Indolent Lymphomas

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT00493454
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Zevalin — DRUG
    .3 mCi IV Over 10 Minutes x 1 Day
  • Rituximab — DRUG
    250 mg/m\^2 IV Over 6 to 8 Hours
  • ^111 In Ibritumomab Tiuxetan — DRUG
    1.6 mg IV Over 10 Minutes x 1 Day

Study Details

Primary Objective: * Overall Response Rate (ORR). Secondary Objectives: * The Duration of Response (DR) and Time to Treatment Progression (TTP) in all patients and in the responders. * Complete Responses (CR)/Complete Responses unconfirmed (CRu), and Partial Responses (PR). * Time to next anticancer therapy (TTNT).

Key Dates

Start date
Apr 30, 2006
Status verified
May 2013
Primary completion
Mar 31, 2011
Completion
Mar 31, 2011

Study Design

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

Arms

  • Experimental: Ibritumomab tiuxetan + Rituximab
    Rituximab 250 mg/m² intravenous (IV) Days 1 and 8, 111In Ibritumomab Tiuxetan (5mCi of 111In, 1.6 mg of Ibritumomab Tiuxetan) IV (over 10 minutes) on Day 1; and 90Y Ibritumomab Tiuxetan 0.3 or 0.4 mCi/kg IV (over 10 minutes) on Day 8 after the Day 8 of Rituximab.

Primary Outcome Measure

Objective Response Rate [ Time Frame: Evaluation 4 weeks after administration of Zevalin up to 3 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
UT MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

By research site
UT MD Anderson Cancer Center· Houston, TX

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