Safety and Efficacy Study of Iodine-131 Anti-B1 Antibody for Chronic Lymphocytic Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00022880
Recruitment Status : Unknown
Verified August 2004 by Corixa Corporation.
Recruitment status was:  Active, not recruiting
First Posted : August 17, 2001
Last Update Posted : June 24, 2005
Information provided by:
Corixa Corporation

Brief Summary:
The purpose of this study is to test the safety of Iodine-131 Anti-B1 Antibody, to see what effects it has on patients with CLL and to determine the highest dose of Iodine-131 Anti-B1 Antibody that can be given without causing severe side effects.

Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia Drug: Iodine-131 Anti-B1 Antibody Phase 1

Detailed Description:

The primary endpoint is to determine the maximum tolerated dose of Iodine-131 Anti-B1 Antibody in patients with CLL. Secondary endpoints include assessment of response rate, duration of response, relapse free survival, time to treatment failure, safety, and survival.

The dose escalation will be started at 35cGy for patients with platelet counts > 100,000 cells/mm3 (Cohort A) and increased by groups in 10cGy increments until the maximum tolerated dose (MTD) is reached. Subsequently, patients with platelet counts from 75,000-100,000 cells/mm3 (Cohort B) will be enrolled starting at 10cGy below the MTD reached in Cohort A and the dose will be escalated in 10cGy increments up to the MTD.

Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Dose-Escalation, Open-Label, Multicenter Study of Iodine-131, Anti-B1 Antibody for Intermediate- and High-Risk B-Cell Chronic Lymphocytic Leukemia
Study Start Date : July 1999

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients must fulfill the criteria for the diagnosis of intermediate-risk B-cell CLL or high-risk B-cell CLL
  • The bone marrow aspirate must demonstrate that greater than or equal to 30% of all nucleated cells are lymphoid.
  • Patients must have evidence that their leukemic lymphocytes express the CD20 antigen.
  • Patients must have been previously treated with chemotherapy or biologic therapy and have progressed on, failed to achieve an objective response (CR or partial response [PR]) on, or progressed after completion of last therapy. Patients must have received at least one therapy containing a purine nucleoside analogue. Patients must not have received more than 4 prior therapies. This includes both chemotherapy and biologic therapy.
  • Patients must have an absolute granulocyte count >500 cells/mm3 and a platelet count of either >100,000 cells/mm3 (Cohort A) or a platelet count of 75,000-100,000 cells/mm3 deemed to be secondary to CLL by the investigator, (Cohort B) within 14 days of study entry. These blood counts must be sustained for 4 weeks without support of hematopoietic cytokines or transfusion of blood products.
  • Patients must have a Karnofsky Performance status of at least 60% and an anticipated survival of at least 3 months.
  • 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 AST <3 x ULN) within 14 days of study entry. For patients with autoimmune hemolytic anemia, the bilirubin must be less than or equal to 8 x ULN.

Exclusion Criteria:

  • Patients who have received prior therapy with cytotoxic chemotherapy or immunosuppressants (with the exception of maintenance prednisone therapy not to exceed a dose of 20 mg/day for autoimmune hemolysis only) within FOUR weeks prior to study entry (6 weeks for nitrosourea compounds) or who exhibit persistent clinical evidence of toxicity. The prednisone must have been started more than 4 weeks prior to study entry.
  • Patients with progressive disease within 1 year of irradiation arising in a field that has been previously irradiated with >3500 cGy.
  • 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 CLL, 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 who have been disease-free of another cancer for greater than 5 years must be carefully assessed at the time of study entry to rule out recurrent disease.
  • Patients with known HIV infection.
  • Patients who are pregnant or nursing. Patients of childbearing potential must undergo a serum pregnancy test within 7 days prior to study entry. Males and females must agree to use a contraceptive method from enrollment to 6 months after receiving Iodine-131 Anti-B1 Antibody.
  • Patients who are concurrently receiving either approved or non-approved (through another protocol) anti-cancer drugs or biologics.
  • Patients with evidence of active infection requiring intravenous treatment with anti-infectives.
  • Patients known to be HAMA positive.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00022880

United States, California
Stanford University Medical Center
Palo Alto, California, United States, 94305
United States, New York
Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11041
Sponsors and Collaborators
Corixa Corporation
GlaxoSmithKline Identifier: NCT00022880     History of Changes
Other Study ID Numbers: CP-98-018
First Posted: August 17, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: August 2004

Keywords provided by Corixa Corporation:
Chronic Lymphocytic Leukemia
Monoclonal Antibody
Anti-B1 Antibody
Iodine -131 Anti-B1 Antibody
Iodine I 131 Tositumomab

Additional relevant MeSH terms:
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Antibodies, Monoclonal
Cadexomer iodine
Iodine-131 anti-B1 antibody
Immunologic Factors
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Growth Substances
Antineoplastic Agents