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Zevalin® (Ibritumomab Tiuxetan) Followed by Rituxan® (Rituximab) Maintenance in Previously Treated Low Grade Non-Hodgkin’s Lymphoma


Phase 4
18 Years
N/A
Not Enrolling
Both
Lymphoma, Non-Hodgkin, Lymphoma, Low-Grade

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Trial Information

Zevalin® (Ibritumomab Tiuxetan) Followed by Rituxan® (Rituximab) Maintenance in Previously Treated Low Grade Non-Hodgkin’s Lymphoma


The objective of this study is to determine overall response rate, event-free survival,
time-to-progression, time-to-next-therapy, and freedom-from-relapse in patients with
low-grade lymphoma in first or second relapse treated with Zevalin followed by 2 years of
Rituxan maintenance therapy in a multicenter, community-based setting, as well as evaluate
relative response rates in populations with and without prior rituximab therapy, in first
versus second relapse, and with and without bulky (> 5 cm in greatest diameter) disease.

To meet the initial trial enrollment goal of 300 patients over two years, 42 total sites
were activated. The study has subsequently closed to accrual. Currently 8 sites remain
active to follow the 12 subjects enrolled in the past year.


Inclusion Criteria:



- Follicular non-Hodgkin’s lymphoma including SLL in first or second relapse.

- No anticancer therapy for three wks (six wks if nitrosourea or Mitomycin C); not
rituximab refractory.

- Age >= 18 years, not pregnant or lactating.

- Expected survival >= 3 mths; PS 0, 1, or 2.

- ANC >= 1,500/mm3, platelet counts >= 100,000/mm3.

- Total bilirubin > 2.0 mg/dL, creatinine > 2.0 mg/dL.

- Total lymphocyte count < 5,000/mm3 for SLL.

- <25% bone marrow involvement with lymphoma.

Exclusion Criteria:

- Prior ABMT or ASCT, hypocellular or marked reduction in bone marrow precursors, or
history of failed stem cell collection.

- Bulky areas of disease more than 10 cm in diameter.

- Patients with CLL, CNS, or mantle cell lymphoma.

- Hx of HIV/AIDS related lymphoma, hepatitis B or C.

- Prior radioimmunotherapy or XRT to >25% of active bone marrow.

- G-CSF or GM-CSF within 2 wks, pegylated G-CSF within 4 wks of treatment

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine overall response rate, event-free survival, time-to-progression, time-to-next-therapy, and freedom-from-relapse in pts with low-grade lymphoma in first or second relapse treated with Zevalin® followed by 2 yrs of Rituxan maintenance therapy

Principal Investigator

Wayne Saville

Investigator Role:

Study Director

Investigator Affiliation:

Biogen Idec

Authority:

United States: Food and Drug Administration

Study ID:

001-03-ZEV

NCT ID:

NCT00168727

Start Date:

June 2003

Completion Date:

October 2005

Related Keywords:

  • Lymphoma, Non-Hodgkin
  • Lymphoma, Low-Grade
  • Radioimmunotherapy
  • Antigens, CD20
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

Loma Linda UniversityLoma Linda, California  92354
Presbyterian Hospital Cancer CenterCharlotte, North Carolina  28204
North County OncologyOceanside, California  92056
Medical Specialists of FairfieldFairfield, Connecticut  
Queens HospitalHonolulu, Hawaii  
Northwest Oncology and HematologyElk Grove Village, Illinois  
Horizon Oncolgy CenterLafayette, Indiana  
Specialists in Hematology/OncologySt. Louis, Missouri