Zevalin® Followed by Rituxan® Maintenance in Previously T... | NCT00168727

ID	Type	Description	Link
Former Biogen Idec: 106-I001

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2003Actual

Primary Completion Date

Not provided

Completion Date

Oct 31, 2005Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 15, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 21, 2023

Last Update Posted Date

Aug 23, 2023Actual

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
ibritumomab tiuxetan (Zevalin®)	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	Description	Time Frame
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

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Wayne Saville	Biogen	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Loma Linda University		Loma Linda	California		United States
North County Oncology

ID	Term
D008223	Lymphoma
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D006425	Hemic and Lymphatic Diseases
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases