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

First listed
Jun 28, 2007
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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