Clinical trial NCT00168727: Zevalin® Followed by Rituxan® Maintenance in Previously Treated Low Grade Non-Hodgkin's Lymphoma
Official title: Zevalin® (Ibritumomab Tiuxetan) Followed by Rituxan® (Rituximab) Maintenance in Previously Treated Low Grade Non-Hodgkin's Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Lymphoma, Non-Hodgkin
Lymphoma, Low-Grade
Keywords: Radioimmunotherapy
Antigens, CD20
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety and effectiveness of a treatment regimen using Zevalin® plus Rituxan® for patients who have low grade Non-Hodgkin's Lymphoma (NHL) or relapsed Non-Hodgkin's lymphoma and have been previously treated. This study will use an experimental scheduling regimen. No chemotherapy will be used in this study.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
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
Secondary outcomes:
measure: 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.
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
city: Oceanside
country: United States
facility: North County Oncology
state: California
city: Fairfield
country: United States
facility: Medical Specialists of Fairfield
state: Connecticut
city: Honolulu
country: United States
facility: Queens Hospital
state: Hawaii
city: Elk Grove Village
country: United States
facility: Northwest Oncology and Hematology
state: Illinois
city: Lafayette
country: United States
facility: Horizon Oncolgy Center
state: Indiana
city: Saint Louis
country: United States
facility: Specialists in Hematology/Oncology
state: Missouri
city: Charlotte
country: United States
facility: Presbyterian Hospital Cancer Center
state: North Carolina
Study officials:
affiliation: Biogen
name: Wayne Saville
role: STUDY_DIRECTOR
References: