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A Phase 3 Open-label Multicenter Randomized Study to Compare the Efficacy and Safety of Zevalin Therapeutic Regimen Following R CVP With R CVP Alone in High Risk Subjects With Previously Untreated CD20 Positive Follicular Non Hodgkin's Lymphoma


Phase 3
18 Years
N/A
Not Enrolling
Both
Follicular Lymphoma, Lymphoma, Follicular

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Trial Information

A Phase 3 Open-label Multicenter Randomized Study to Compare the Efficacy and Safety of Zevalin Therapeutic Regimen Following R CVP With R CVP Alone in High Risk Subjects With Previously Untreated CD20 Positive Follicular Non Hodgkin's Lymphoma


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety

Outcome Time Frame:

18 months

Safety Issue:

Yes

Principal Investigator

Igor Gorbatchevsky, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Cell Therapeutics

Authority:

United States: Food and Drug Administration

Study ID:

106NH301

NCT ID:

NCT00384111

Start Date:

October 2006

Completion Date:

March 2010

Related Keywords:

  • Follicular Lymphoma
  • Lymphoma, Follicular
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, Non-Hodgkin

Name

Location

Integrated Community Oncology Network Jacksonville Beach, Florida  32250
Oncology Hematology Care Inc. Cincinnati, Ohio  45242
Gulfcoast Oncology Associates St. Petersburg, Florida  33705
Tennessee Oncology Nashville, Tennessee  37203
Wellstar-Northwest Georgia Oncology Centers Marietta, Georgia  30060
Chattanooga Oncology Hematology Care Chattanooga, Tennessee  37404