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Safety and Efficacy of Zevalin in the Treatment of Non-Hodgkin's Lymphoma

Sponsor
Biogen (Industry)
Overall Status
Terminated
CT.gov ID
NCT00057343
Collaborator
(none)
400
Enrollment
67
Locations
6
Patients Per Site

Study Details

Study Description

Brief Summary

The purpose of this study is to provide treatment for patients who have relapsed NHL or refractory NHL, and to determine the effectiveness and safety of the Zevalin and Rituxan regimens or Rituxan therapy alone on your disease.

Condition or Disease Intervention/Treatment Phase
  • Drug: Zevalin (ibritumomab tiuxetan)
  • Drug: Rituxan (rituximab)
 Phase 3

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Prospectively Randomized, Phase III, Multicenter, Controlled Trial to Evaluate the Safety and Efficacy of the Zevalin Therapeutic Regimen Plus Rituxan Compared With Rituxan Alone in Patients With Relapsed or Refractory Follicular NHL
Study Start Date :
Mar 1, 2003

Outcome Measures

Primary Outcome Measures

  1. Event-free survival []

Secondary Outcome Measures

  1. overall response rate []

  2. complete response rate []

  3. unconfirmed complete response rate []

  4. partial response rate []

  5. duration of response []

  6. time to progression []

  7. time-to-next anticancer therapy []

  8. quality of life []

  9. overall survival []

  10. safety profile []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

Summary of major inclusion and exclusion criteria. Other Safety criteria will need to be met.

Inclusion Criteria:

  • Histologically confirmed, relapsed or refractory CD20+ follicular B-cell NHL within 12 months of Study Day 1 (without clinical evidence of transformation). NHL must require treatment as determined by an increase in overall tumor size. The presence of B symptoms, and/or the presence of masses which are causing ongoing clinical symptoms.

  • Bidimensionally measurable disease meeting the minimum requirement of at least 1 lesion >/= 2.0 cm in a single dimension.

  • No lymphoma therapy for 3 weeks prior to Study Day 1.

  • Patients must be recovered from all toxicities associated with prior surgery, radiation therapy, chemotherapy, or immunotherapy.

  • Signed IRB-approved informed consent.

  • Greater than 18 years of age.

  • Expected survival >/= 3 months.

  • WHO performance status of </= 2.

  • Acceptable hematologic status, liver function, renal function, and pulmonary function.

  • Female patients who are not pregnant or lactating.

  • Men and women of reproductive potential who are following accepted birth control methods.

Exclusion Criteria:

  • Patients with impaired bone marrow reserve, which may be indicated by prior myeloablative therapy with autologous bone marrow transplantation (ABMT) or peripheral blood stem cell (PBSC) rescue.

  • Prior radioimmunotherapy, including the Zevalin regimen.

  • Prior immunotherapy, including Rituxan therapy within 6 months of Study Day 1.

  • Rituxan-refractory (no response to most recent Rituxan-containing regimen, or TTP was < 6 months).

  • Presence of CNS lymphoma.

  • Patients with chronic lymphocytic leukemia (CLL).

  • Known history of HIV or AIDS.

  • Serious nonmalignant disease or infection

  • Major surgery, other than diagnostic surgery, within 4 weeks of Study Day 1.

  • Patients who received investigational product within 4 weeks of Study Day 1 or patients who may experience long-term toxicity from a previous investigational therapy.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Research Site Huntsville Alabama United States
2 Research Site Scottsdale Arizona United States
3 Research Site Little Rock Arkansas United States
4 Research Site Bakersfield California United States
5 Research Site Concord California United States
6 Research Site Duarte California United States
7 Research Site Loma Linda California United States
8 Research Site Los Angeles California United States
9 Research Site Mission Viejo California United States
10 Research Site Newport Beach California United States
11 Research Site Orange California United States
12 Research Site Sacramento California United States
13 Biogen Idec Incorporated San Diego California United States 92121
14 Research Site San Diego California United States
15 Research Site Santa Barbara California United States
16 Research Site Vallejo California United States
17 Research Site Farmington Connecticut United States
18 Research Site Newark Delaware United States
19 Research Site Jacksonville Florida United States
20 Research Site Lakeland Florida United States
21 Research Site Boise Idaho United States
22 Research Site Coeur D'Alene Idaho United States
23 Research Site Aurora Illinois United States
24 Research Site Chicago Illinois United States
25 Research Site Evanston Illinois United States
26 Research Site Harvey Illinois United States
27 Research Site Maywood Illinois United States
28 Research Site Urbana Illinois United States
29 Research Site Indianapolis Indiana United States
30 Research Site Munster Indiana United States
31 Research Site Kansas City Kansas United States
32 Research Site Baltimore Maryland United States
33 Research Site Boston Massachusetts United States
34 Research Site Ann Arbor Michigan United States
35 Research Site Detroit Michigan United States
36 Research Site Flint Michigan United States
37 Research Site Royal Oak Michigan United States
38 Research Site St. Joseph Michigan United States
39 Research Site Minneapolis Minnesota United States
40 Research Site Rochester Minnesota United States
41 Research Site Jackson Mississippi United States
42 Research Site Tupelo Mississippi United States
43 Research Site Columbia Missouri United States
44 Research Site Kansas City Missouri United States
45 Research Site St. Louis Missouri United States
46 Research Site Albuquerque New Mexico United States
47 Research Site Farmington New Mexico United States
48 Research Site Bronx New York United States
49 Research Site Buffalo New York United States
50 Research Site Manhasset New York United States
51 Research Site New York New York United States
52 Research Site Bismark North Dakota United States
53 Research Site Cleveland Ohio United States
54 Research Site Toledo Ohio United States
55 Research Site Portland Oregon United States
56 Research Site Philadelphia Pennsylvania United States
57 Research Site Pittsburgh Pennsylvania United States
58 Research Site Charleston South Carolina United States
59 Research Site Greenville South Carolina United States
60 Research Site Nashville Tennessee United States
61 Research Site Houston Texas United States
62 Research Site Lubbock Texas United States
63 Research Site Temple Texas United States
64 Research Site Salt Lake City Utah United States
65 Research Site Bremerton Washington United States
66 Research Site Morgantown West Virginia United States
67 Research Site Wausau Wisconsin United States

Sponsors and Collaborators

  • Biogen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00057343
Other Study ID Numbers:
  • 106-10
First Posted:
Apr 1, 2003
Last Update Posted:
Sep 12, 2006
Last Verified:
Sep 1, 2006
Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Rituximab

Study Results

No Results Posted as of Sep 12, 2006