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A Multi-Center, Randomized, Phase 3 Study of Rituximab Versus Iodine I 131 Tositumomab Therapeutic Regimen For Patients With Relapsed Follicular Non-Hodgkins Lymphoma

Phase 3
18 Years
Not Enrolling
Lymphoma, Non-Hodgkin, Non-Hodgkin's Lymphoma

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Trial Information

A Multi-Center, Randomized, Phase 3 Study of Rituximab Versus Iodine I 131 Tositumomab Therapeutic Regimen For Patients With Relapsed Follicular Non-Hodgkins Lymphoma

Inclusion Criteria

Inclusion criteria:

- Histologically confirmed diagnosis of follicular lymphoma

- Recurrent lymphoma after one or two qualifying therapy regimen(s)

- Patients must not have progressed within 4 weeks of their last chemotherapy dose

- Rituximab may have been used once as a single agent, in one continuous course of 4-8
weekly infusions (10-week period), or in combination with chemotherapy in a single
prior treatment

- Patients whose prior therapy includes rituximab must have had a 6 month or greater
response duration following the rituximab-containing regimen.

- Performance status of at least 70% on the Karnofsky Scale and an anticipated survival
of at least three months

- Adequate absolute neutrophil count and platelet count within 21 days of study entry
without support of blood products/growth factors

- Adequate renal function and adequate hepatic within 21 days of study entry

- Measurable disease, with at least one lesion measuring >/=2.0 cm x 2.0 cm by CT scan

- Human Anti Mouse Antigen negative

- Written informed consent prior to study entry

Exclusion criteria:

- Histologic transformation to diffuse, large cell lymphoma.

- History of more than one course of Rituximab

- Disease limited to single lymph node or single group of nodes

- Involvement of 25% of the intratrabecular marrow by bone marrow biopsy specimen.

- Active infection requiring IV antibiotics at the time of study entry

- New York Heart Association Class III/IV heart disease

- Prior chemotherapy, biologic, radiation or steroid therapy for NHL within 8 weeks

- Any prior radioimmunotherapy

- Prior history of malignancy other than lymphoma (except for treated basal cell,
squamous cell skin cancer, in situ cervical cancer, or other cancer that is
disease-free for 5 years)

- Known HIV infection

- Hepatitis B positive

- Known central nervous system involvement

Type of Study:


Study Design:

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

Outcome Measure:

Progression-free Survival

Outcome Description:

Progression-free survival is defined as the time from the initial date of dosing to the first documented disease progression or death. Disease assessment was based on the International Workshop to Standardize Response Criteria (IWSRC) for Non-Hodgkin's Lymphoma (NHL). Progression is defined as at least a 50% increase in the sum of the perpendicular diameters of all measurable lesions and the appearance of new lesions at least 1.4 centimeters (cm) x 1.4 cm (i.e., 2.0 cm^2) by radiographic evaluation or greater than 1.0 cm by palpation upon physical examination.

Outcome Time Frame:

From first dose of treatment until disease progression or death, whichever came first (median follow-up for the Rituximab and Bexxar groups was 38.9 and 42.2 months, respectively)

Safety Issue:


Principal Investigator

GSK Clinical Trials, MD

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

October 2004

Completion Date:

April 2016

Related Keywords:

  • Lymphoma, Non-Hodgkin
  • Non-Hodgkin's Lymphoma
  • rituximab
  • tositumomab and iodine I 131 tositumomab
  • non-Hodgkins lymphoma
  • radioimmunotherapy
  • anti-B1 antibody
  • Bexxar
  • NHL
  • Tositumomab
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, Non-Hodgkin



GSK Investigational SiteSeattle, Washington  98133