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Phase II Study of Ibritumomab Tiuxetan (Zevalin®) in Patients With Previously Untreated Marginal Zone Lymphoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lymphoma

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Trial Information

Phase II Study of Ibritumomab Tiuxetan (Zevalin®) in Patients With Previously Untreated Marginal Zone Lymphoma


OBJECTIVES:

Primary

- Assess the clinical response rate (complete response [CR], unconfirmed CR, and partial
response) in patients with previously untreated marginal zone lymphoma treated with
yttrium Y 90 ibritumomab tiuxetan and rituximab.

Secondary

- Determine progression-free survival, in terms of time to relapse or progression, of
patients treated with this regimen.

- Determine overall survival of patients treated with this regimen.

- Assess local disease control in these patients

- Evaluate the safety and tolerability of this regimen in these patients.

OUTLINE: Patients receive rituximab IV and indium In 111 ibritumab tiuxetan IV over 10
minutes on day 1. Patients with acceptable biodistribution receive rituximab IV and yttrium
Y 90 ibritumomab tiuxetan IV on day 7, 8, or 9.

After the completion of study treatment, patients are followed every 3 months for 2 years
and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Clinical response rate (complete response [CR], unconfirmed CR, and partial response)

Outcome Time Frame:

6 years

Safety Issue:

No

Principal Investigator

Izidore S. Lossos, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Miami Sylvester Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

EPROST-20060078

NCT ID:

NCT00453102

Start Date:

February 2006

Completion Date:

Related Keywords:

  • Lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • splenic marginal zone lymphoma
  • stage III marginal zone lymphoma
  • stage IV marginal zone lymphoma
  • contiguous stage II marginal zone lymphoma
  • noncontiguous stage II marginal zone lymphoma
  • stage I marginal zone lymphoma
  • Lymphoma
  • Lymphoma, B-Cell, Marginal Zone

Name

Location
University of Miami Sylvester Comprehensive Cancer Center - Miami Miami, Florida  33136