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Phase II Trial of Iodine-131 Anti-B1 Antibody for Previously Untreated, Advanced Stage, Low Grade Non-Hodgkin's Lymphoma

Phase 2
18 Years
Not Enrolling
Lymphoma, Non-Hodgkin

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Trial Information

Phase II Trial of Iodine-131 Anti-B1 Antibody for Previously Untreated, Advanced Stage, Low Grade Non-Hodgkin's Lymphoma

Inclusion Criteria

Inclusion Criteria

- Patients must have a histologically confirmed diagnosis of lowgrade non-Hodgkin's
B-cell lymphoma. The following low-grade histologies are included: small lymphocytic
(with or without plasmacytoid differentiation); follicular, small cleaved;
follicular, mixed small cleaved and follicular large cell (less than 50% large cell
component); and monocytoid B-cell lymphoma.

- 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 (Coulter Clone®) or similar commercially available CD20
antibody (>50% of tumor cells are positive) or evidence of CD20 positivity by flow
cytometry (>50% of tumor cells are positive) are acceptable evidence of CD20
positivity. Testing of tumor tissue from any time in the course of the patient's
disease is acceptable.

- Patients must have Ann Arbor stage III or IV extent of disease after complete

- Patients must not have had any previous treatment for low-grade lymphoma including
chemotherapy or radiation. They may be newly diagnosed or observed without treatment
after diagnosis. Symptomatic and asymptomatic patients will be eligible.

- 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 neutrophil count (ANC) >1500 cells/mm3 and a platelet
count >100,000 cells/mm3 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
≥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- 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 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 active obstructive hydronephrosis.

- 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 were previously given any monoclonal or polyclonal antibodies of any
non-human species for either diagnostic or therapeutic purposes. This includes
engineered chimeric and humanized antibodies.

- Patients who are concurrently receiving either approved or nonapproved (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 With Confirmed Response, Including Participants With Complete Response (CR), Clinical Complete Response (CCR), and Partial Response (PR)

Outcome Description:

Confirmed response required CR, CCR, or PR, which were confirmed by 2 separate response evaluations >=4 weeks apart. CR: Complete resolution of all disease-related radiological abnormalities and disappearance of all signs and symptoms related to the disease. CCR: Complete resolution of all disease-related symptoms, but residual foci, thought to be residual scar tissue, are present. PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions with no new lesions.

Outcome Time Frame:

From Study Day 0 (start of treatment) up to 12 years (long-term follow up)

Safety Issue:


Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

June 1996

Completion Date:

October 2011

Related Keywords:

  • Lymphoma, Non-Hodgkin
  • Radioimmunotherapy
  • Anti-B1 Antibody and Iodine-131 Anti-B1 Antibody
  • Tositumomab and Iodine I 131 Tositumomab
  • non-Hodgkin's Lymphoma
  • Bexxar
  • Lymphoma
  • Lymphoma, Non-Hodgkin