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Study of Bexxar Combined With External Beam Radiation Therapy for Patients With Relapsed, Bulky Non-Hodgkin's Lymphoma

Phase 2
19 Years
Open (Enrolling)
Lymphoma, Non-Hodgkin

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Trial Information

Study of Bexxar Combined With External Beam Radiation Therapy for Patients With Relapsed, Bulky Non-Hodgkin's Lymphoma

At the present time over 1,600 patients have been treated with iodine I 131 tositumomab
(Bexxar) in a variety of clinical trials. The overall clinical data demonstrate that
patients with relapsed or refractory low-grade or transformed low-grade, CD20-positive,
B-cell non-Hodgkin's lymphoma derive significant therapeutic benefit from iodine I 131
tositumomab. Data describing its safety and efficacy are available for over 700 patients. In
aggregate, the data demonstrate that iodine I 131 tositumomab produces: 1) high overall and
complete response rates, 2) clinically meaningful prolongations of response compared to
those achieved after patients last prior therapies, 3) durable complete responses, and 4)
manageable toxicity in patients with low grade or transformed non-Hodgkin's lymphoma. The
purpose of this study is to study the safety and efficacy of this treatment in combination
with external beam radiation in patients with relapsed bulky NHL.

Inclusion Criteria:

- Histologically confirmed low grade CD20+ B cell NHL patients who have
relapsed after chemotherapy or are chemotherapy resistant and have one or more sites of
disease measuring more than 5 cm.

- The patients must have failed at least one chemotherapy regimen

- No anticancer treatment for three weeks prior to study initiation (six weeks if
Rituximab, nitrosourea or Mitomycin C), and fully recovered from all toxicities
associated with prior surgery, radiation, chemotherapy or immunotherapy

- An IRB approved signed informed consent

- Age greater and or equal to 19 years

- Expected survival of at least 6 months

- Prestudy Performance Status of 0, 1 or 2 according to the WHO

- Acceptable laboratory status within 2 weeks prior to patient enrollment including:

- ANC of at least 1,500/mm^3, platelet count at least 100,000/mm3, Hct greater
than 30% and Hgb greater than 9.0 gm

- Bilirubin less than or equal to 2.0, Creatinine less than or equal to 2.0

- Bone marrow involvement with lymphoma less than 25% (bilateral bone marrow)
within 6 weeks of enrollment

- Acceptable birth control method for men and women of reproductive potential

- Female patients who are not pregnant or lactating

Exclusion Criteria:- Disease progression within 3 months of last chemotherapy

- Prior myeloablative therapies with bone marrow transplantation or peripheral stem
cell rescue

- Patients with impaired bone marrow reserve as indicated by one or more of the

- Platelet count less than 100,000/mm^3

- Hypocellular bone marrow (less than or equal to 15% cellularity)

- Marked reduction in bone marrow precursors of one or more cell lines

- History of failed stem cell collection

- Prior treatment with Fludarabine

- Prior radioimmunotherapy

- Presence of CNS lymphoma

- Patients with HIV or AIDS-related lymphoma

- Patients with evidence of myelodysplasia on bone marrow biopsy or abnormal bone
marrow cytogenetics

- Patients who have received prior external beam radiation therapy to more than 25% of
active bone marrow

- Patients who have received G-CSF or GM-CSF therapy within 3 weeks prior to treatment

- Pregnant or lactating women

- Presence of HAMA reactivity in patients with prior exposure to murine antibodies or

- Serious nonmalignant disease or infection, which, in the opinion of the investigator
and/or sponsor, would compromise other protocol objectives

- Another primary malignancy (other than squamous cell and basal cell CA of the skin,
in situ CA of the cervix, or treated prostate cancer with stable PSA) for which the
patients has not been disease free for at least 3 years

- Major surgery, other than diagnostic surgery, within 4 weeks

- Patients with pleural effusion

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine percentage of patients with CR at 12 weeks (CR or CRu/PR with PET negativity)

Outcome Time Frame:

12 weeks

Safety Issue:


Principal Investigator

Susan J Knox

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University


United States: Institutional Review Board

Study ID:




Start Date:

January 2007

Completion Date:

December 2015

Related Keywords:

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



Stanford University School of Medicine Stanford, California  94305-5317