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Phase 3 Study of Zevalin Following R-CVP in Previously Untreated Patients With Follicular NHL
This study has been terminated.
( A pending new protocol will replace this study. )
First Received: October 3, 2006   Last Updated: September 23, 2008   History of Changes
Sponsor: Cell Therapeutics
Information provided by: Cell Therapeutics
ClinicalTrials.gov Identifier: NCT00384111
  Purpose

This study will treat follicular lymphoma patients who have not received previous treatment with R-CVP. Half of the patients will receive Zevalin after R-CVP and the other half will receive only R-CVP. The two patient groups will be compared to determine if Zevalin given after R-CVP therapy provides greater benefits than receiving no additional anti-cancer therapy after R-CVP.


Condition Intervention Phase
Follicular Lymphoma
Lymphoma, Follicular
Drug: R-CVP + Zevalin Therapeutic Regimen
Drug: R-CVP
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study
Official Title: A Phase 3, Open-Label, Multicenter, Randomized Study to Compare the Efficacy and Safety of the Zevalin (Ibritumomab Tiuxetan) Therapeutic Regimen Following Cyclophosphamide, Vincristine, Prednisone, and Rituximab (R CVP) With R CVP Alone in High Risk Subjects With Previously Untreated CD20 Positive Follicular Non Hodgkin's Lymphoma

Resource links provided by NLM:


Further study details as provided by Cell Therapeutics:

Primary Outcome Measures:
  • Safety [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Safety [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

Enrollment: 26
Study Start Date: October 2006
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
R-CVP plus Zevalin Therapeutic Regimen
Drug: R-CVP + Zevalin Therapeutic Regimen
Standard R-CVP followed by Zevalin Theraeputic Regimen: Day 1: 250 mg/m2 Rituxan followed by 5 mCi 111In Zevalin. Day 7: 250 mg/m2 Rituxan followed by 0.4 mCi/kg Zevalin
2: Active Comparator
R-CVP
Drug: R-CVP
Standard R-CVP

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must give written informed consent and any authorizations required by local law (e.g., Protected Health Information).
  • Age greater than or equal to 18 years at the time of informed consent.
  • Histologically confirmed follicular NHL according to the Revised European American Lymphoma (REAL)/World Health Organization (WHO)classification (from initial diagnosis); grades 1, 2, or 3.
  • Bi-dimensionally measurable lesion(s) in at least one site.
  • High risk NHL as defined by a follicular lymphoma international prognostic index (FLIPI) of 3, 4, or 5 assessed within 3 months prior to randomization.
  • NHL requires treatment as determined by the investigator.
  • Confirmed CD20+ lymphoma cells.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1,or 2.
  • Expected survival of greater than or equal to 3 months.
  • Male subjects and female subjects of child bearing potential willing to practice effective contraception during the study and willing and able to continue contraception for 1 year after their last dose of study treatment (R CVP for subjects in the observation arm and the Zevalin therapeutic regimen for subjects in the Zevalin arm).

Exclusion Criteria:

  • Previous anticancer treatment for NHL, including chemotherapy, immunotherapy, radiation (locoregional or extended field), radioimmunotherapy, or investigational therapy.
  • Known seropositivity for hepatitis C virus, hepatitis B virus (surface antigen-positive), or other active infection uncontrolled by treatment.
  • Known diagnosis of human immunodeficiency virus infection.
  • Presence of primary gastric, central nervous system (CNS), or testicular lymphoma, or transformed lymphoma, or chronic lymphocytic leukemia (CLL).
  • Active therapy within previous 5 years for other malignancy, except non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma.
  • Abnormal liver function: total bilirubin >1.5 X upper limit of normal (ULN) or ALT >2.5 X ULN.
  • Impairment of renal function (serum creatinine >1.5 X ULN) not due to lymphoma.
  • Concurrent severe and/or uncontrolled medical disease (e.g., uncontrolled diabetes, congestive heart failure, myocardial infarction within 6 months of study, unstable and uncontrolled hypertension, chronic renal disease, or active uncontrolled infection) that could compromise participation in the study.
  • Known hypersensitivity to murine and/or chimeric proteins.
  • History of severe allergic or anaphylactic reactions.
  • Known allergy to any components present in rituximab, cyclophosphamide, vincristine, and prednisone (CVP), or Zevalin.
  • Treatment with another study treatment or approved therapy for investigational use within the 12 weeks prior to randomization.
  • Exposure to monoclonal antibodies, cytokines, growth factors, soluble receptors, other recombinant products, or fusion proteins.
  • Females with a positive pregnancy test result at screening or who are currently breastfeeding.
  • Inability to comply with study requirements.
  • Major surgery within 28 days except for diagnosis.
  • In need of immediate intervention to treat life threatening complications.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00384111

Locations
United States, Florida
Integrated Community Oncology Network
Jacksonville, Florida, United States, 32256
Gulfcoast Oncology Associates
St. Petersburg, Florida, United States, 33705
United States, Georgia
Wellstar-Northwest Georgia Oncology Centers
Marietta, Georgia, United States, 30060
United States, Ohio
Oncology Hematology Care Inc.
Cincinnati, Ohio, United States, 45242
United States, Tennessee
Tennessee Oncology
Nashville, Tennessee, United States, 37203
Chattanooga Oncology Hematology Care
Chattanooga, Tennessee, United States, 37404
Sponsors and Collaborators
Cell Therapeutics
Investigators
Study Director: Igor Gorbatchevsky, M.D. Cell Therapeutics
  More Information

No publications provided

Responsible Party: Cell Therapeutics, Inc ( Igor Gorbatchevsky, M.D. )
Study ID Numbers: 106NH301
Study First Received: October 3, 2006
Last Updated: September 23, 2008
ClinicalTrials.gov Identifier: NCT00384111     History of Changes
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lymphatic Diseases
Neoplasms
Immunoproliferative Disorders
Neoplasms by Histologic Type
Immune System Diseases
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma

ClinicalTrials.gov processed this record on February 08, 2010