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Phase II Study of Iodine-131 Anti-B1 Antibody for Non Hodgkin's Lymphoma Patients Who Have Previously Received Rituximab

Phase 2
18 Years
Not Enrolling
Lymphoma, Non-Hodgkin, Non-Hodgkin's Lymphoma

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Trial Information

Phase II Study of Iodine-131 Anti-B1 Antibody for Non Hodgkin's Lymphoma Patients Who Have Previously Received Rituximab

Inclusion Criteria

Inclusion Criteria

- Patients must have a histologically confirmed diagnosis of low-grade non-Hodgkin's
B-cell lymphoma according to International Working Formulation.

- Patients must have evidence that their tumor tissue expresses the CD20 antigen.
Immunoperoxidase stains of paraffin-embedded tissue showing positive reactivity with
L26 antibody or immunoperoxidase stains of frozen tissue showing positive reactivity
with Anti-B1 Antibody or evidence of CD20 positivity by flow cytometry are acceptable
evidence of CD20 positivity.

- Patients must have been treated with at least 4 doses of rituximab at any time and
failed to achieve an objective response (CR, CCR, PR) or relapse/progressed during
treatment or following the completion of rituximab therapy.

- Patients must have a performance status of at least 60% on the Karnofsky Scale and an
anticipated survival of at least 3 months.

- Patients must have an absolute granulocyte count >1500 cells/mm3 (US) and a platelet
count >100,000 cells/mm3 (US) within 14 days of study entry. These blood counts must
be sustained without support of hematopoietic cytokines or transfusion of blood

- Patients must have adequate renal function (defined as serum creatinine <1.5 x upper
limit of normal [ULN]) and hepatic function (defined as total bilirubin <1.5 x ULN
and aspartate transaminase [AST] <5 x ULN) within 14 days of study entry.

- Patients must have bi-dimensionally measurable disease. At least one lesion must be
greater than or equal to 2 x 2 cm (by computed tomography [CT] scan).

- Patients must be at least 18 years of age.

- Patients must give written informed consent and sign an IRB/EC- approved informed
consent form prior to study entry.

Exclusion Criteria

- Patients with more than an average of 25% of the intratrabecular marrow space
involved by lymphoma in bone marrow biopsy specimens as assessed microscopically
within 42 days of study entry. Bilateral posterior iliac crest core biopsies are
required if the percentage of intratrabecular space involved exceeds 10% on a
unilateral biopsy. The mean of bilateral biopsies must be no more than 25%.

- Patients who received cytotoxic chemotherapy, radiation therapy, immunosuppressants,
or cytokine treatment within 4 weeks prior to study entry (6 weeks of nitrosourea
compounds) or who exhibit persistent clinical evidence of toxicity. The use of
systemic steroids must be discontinued at least 1 week prior to study entry.

- Patients with prior hematopoietic stem cell transplant following high-dose
chemotherapy or chemo/radiotherapy.

- Patients with active obstructive hydronephrosis.

- Patients with evidence of active infection requiring intravenous (IV) antibiotics at
the time of study entry.

- Patients with New York Heart Association class III or IV heart disease or other
serious illness that would preclude evaluation.

- Patients with prior malignancy other than lymphoma, except for adequately treated
skin cancer, in situ cervical cancer, or other cancer for which the patient has been
disease-free for 5 years.

- Patients with known HIV infection.

- Patients with known brain or leptomeningeal metastases.

- Patients who are pregnant or nursing. Patients of childbearing potential must undergo
a pregnancy test within 7 days of study entry and radiolabeled antibody is not to be
administered until a negative result is obtained. Males and females must agree to use
effective contraception for 6 months following the radioimmunotherapy.

- Patients with previous allergic reactions to iodine. This does not include reacting
to IV iodine-containing contrast materials.

- Patients who previously received radioimmunotherapy.

- Patients with progressive disease within 1 year of irradiation arising in a field
that has been previously irradiated with > 3500 cGy.

- Patients who are HAMA positive.

- Patients who are concurrently receiving either approved or non-approved (through
another protocol) anti-cancer drugs or biologics.

Type of Study:


Study Design:

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

Outcome Measure:

Number of Participants (Par.) With Confirmed Response as Assessed by the Investigator

Outcome Description:

Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. Par. with confirmed response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Clinical Complete Response (CCR: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present), or Partial Response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions).

Outcome Time Frame:

Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years

Safety Issue:


Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

July 1998

Completion Date:

April 2010

Related Keywords:

  • Lymphoma, Non-Hodgkin
  • Non-Hodgkin's Lymphoma
  • Tositumomab
  • radioimmunotherapy
  • rituximab
  • anti-B1
  • I 131
  • Bexxar
  • iodine
  • non-Hodgkin's lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin