Clinical Trial · NCT00319332

A Comparative Study Of Iodine I 131 Tositumomab Therapeutic Regimen Versus Ibritumomab Tiuxetan Therapeutic Regimen

Overview

This is a multi-center, randomized, study to compare Iodine I 131 Tositumomab therapeutic regimen to Ibritumomab Tiuxetan therapeutic regimen in the treatment of patients with relapsed or transformed follicular non-Hodgkin's B-cell lymphoma. A total of 350 patients, approximately 175 patients per arm, will be enrolled at 30 to 40 sites in the United States.

Sponsor

Unknown Organization

Phase

Phase 3

Contacts

GSK Clinical Trials, MD (STUDY_DIRECTOR)

ClinicalTrials.gov

NCT00319332

Drug / Compound

tositumomab

Isotope(s):

Target(s):

cd20

Ligand Class: Antibodies

Eligibility

Inclusion

Patients diagnosed with diffuse large cell lymphoma at study enrollment must have a historical or contemporaneous lymph node biopsy that demonstrates a diagnosis of follicular lymphoma.
Blood products and/or growth factors should not be taken within 4 weeks prior to blood draw.
Absolute neutrophil count \>/= 1500 cells/mm3 and platelet count \>/=100,000/mm3 within 21 days prior to study enrollment.
The patient must have either not responded or responded with a duration of response of less than 6 months to a Rituximab-containing regimen, Performance status of at least 70% on the Karnofsky Scale and an anticipated survival of at least three months.
Adequate renal function (defined as serum creatinine \<1.5 x upper limit of normal) and adequate hepatic function (defined as total bilirubin \<1.5x upper limit of normal and AST \<5x upper limit of normal) within 21 days prior to study enrollment.
Bi-dimensionally measurable disease with at least one lesion measuring 4.0 cm2 by CT scan.
Human Anti-Murine Antibody (HAMA) negative within 21 days prior to study enrollment.
Histologically confirmed diagnosis of follicular lymphoma, Grade 1, 2, or 3, or diffuse large cell lymphoma concurrent with or following the diagnosis of follicular lymphoma (WHO/REAL classification).
International Working Formulation histological equivalents of Follicular, small cleaved; Follicular, mixed small-cleaved and large-cell; follicular large-cell; or Transformed diffuse large cell lymphoma following or concurrent with a diagnosis of follicular lymphoma.
Recurrent lymphoma after at least three qualifying therapy regimens including at least one Rituximab-containing regimen and at least one chemotherapy regimen.

Exclusion

History of failed stem cell collection.
Prior malignancy other than lymphoma, except for adequately treated basal cell or squamous cell skin cancer, in situ uterine cervical cancer, or other cancer for which the patient has been disease-free for five years.
Known brain or leptomeningeal metastases.
Known HIV infection.
Prior radiotherapy to fields encompassing more than 25% of the blood forming marrow.
Prior chemotherapy, biologic therapy, radiation therapy or steroid therapy for NHL within eight weeks prior to screening procedures.
Active infection requiring intravenous antibiotics at the time of study enrollment.
Hypocellular bone marrow (\</=15% cellularity or marked reduction in bone marrow precursors).
New York Heart Association Class III or IV heart disease or other serious illness that would preclude evaluation.
Prior myeloablative therapy.
Prior radioimmunotherapy.
Prior treatment with any non-human, particularly murine monoclonal or polyclonal antibodies for either diagnostic or therapeutic purposes. This exclusion does not extend to the chimeric monoclonal antibody, Rituximab.
Greater than 25% of the intratrabecular marrow space involved by lymphoma in bone marrow biopsy specimens as assessed microscopically within 90 days prior to study enrollment.
HBsAg seropositivity.