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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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22 October 2012 |
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Main ID: |
NCT00453102 |
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Date of registration:
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27/03/2007 |
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Primary sponsor: |
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Public title:
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Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Treating Patients With Previously Untreated Marginal Zone Lymphoma
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Scientific title:
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Phase II Study of Ibritumomab Tiuxetan (Zevalin®) in Patients With Previously Untreated Marginal Zone Lymphoma |
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Date of first enrolment:
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February 2006 |
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Target sample size:
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24 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00453102 |
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Study type:
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Interventional |
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Study design:
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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University of Miami Sylvester Comprehensive Cancer Center Clin |
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Address:
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Telephone:
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866-574-5124 |
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Email:
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Sylvester@emergingmed.com |
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Affiliation:
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Name:
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Izidore S. Lossos, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Miami Sylvester Comprehensive Cancer Center |
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Key inclusion & exclusion criteria
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DISEASE CHARACTERISTICS:
- Histologically confirmed marginal zone lymphoma (MZL)
- Extranodal, splenic, or nodal MZL
- All stages allowed
- Meets 1 of the following criteria:
- Previously untreated nongastric MZL
- Gastric MZL that did not respond to antibiotic therapy given 2-6 months ago
- Measurable or evaluable disease
- Must not have = 25% bone marrow involvement by MZL
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy = 6 months
- Platelet count = 100,000/mm³
- Absolute neutrophil count = 1,500/mm³
- No known HIV positivity
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 6 months after
completion of study treatment
- No physical or mental condition that precludes study compliance
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior or concurrent chemotherapy
- No prior radiotherapy, immunotherapy, systemic corticosteroids, or systemic biologic
anticancer therapy
- No concurrent corticosteroids
- No other concurrent systemic antineoplastic therapy
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Lymphoma
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Intervention(s)
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Drug: Ibritumomab Tiuxetan
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Drug: Rituximab
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Primary Outcome(s)
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Clinical response rate (complete response [CR], unconfirmed CR, and partial response)
[Time Frame: 6 years]
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Secondary ID(s)
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EPROST-20060078
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SCCC-2005133
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WIRB-20060249
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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