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Retreatment Study of Patients With Non-Hodgkin's Lymphoma Who Have Previously Responded to Iodine-131 Anti B1 Antibody

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

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Trial Information

Retreatment Study of Patients With Non-Hodgkin's Lymphoma Who Have Previously Responded to Iodine-131 Anti B1 Antibody

Inclusion Criteria:

- Patients with histologically confirmed initial diagnosis of non-Hodgkin's B-cell

- Patients must have previously responded with a duration of response of at least 3
months to Iodine-131 Anti-B1 Antibody therapy

- Patients must have evidence that their tumor tissue had CD20 expression

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

- Patients must have absolute granulocyte count (ANC) greater than 1,500 cells/mm3 and
platelet count greater than 100,000 cells/mm3 within 14 days of study entry without
support of hematopoietic cytokines or transfusion of blood products

- Patients must have adequate renal (serum creatine less than 1.5 x upper limit of
normal) and hepatic function (total bilirubin less than 1.5 x upper limit of normal
and hepatic transaminases, AST and ALT, less than 5 x upper limit of normal) within
14 days of study entry

- Patients must have bi-dimensionally measurable disease with a least one lesion
greater than or equal to 2 cm x 2 cm by CT scan

- Patients must be at least 18 years of age

- Patients must give written informed consent and sign an Institutional Review
Board/Ethics Committee- approved informed consent form prior to study entry

Exclusion Criteria:

- Patients with more than 25% bone marrow involvement

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

- Patients with active obstructive hydronephoresis

- Patients with evidence of active infection requiring IV antibiotics at time of study

- 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 metasteses

- Patients who are pregnant or nursing

Type of Study:


Study Design:

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

Outcome Measure:

To determine the response rate, complete response rate, duration of response, time to progression, time to treatment failure, safety and survival following Iodine 131 Anti B1 Antibody therapy

Outcome Time Frame:

Long term follow up every 6 months

Safety Issue:


Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

April 1998

Completion Date:

December 2012

Related Keywords:

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