Chronic Lymphocytic LeukemiaPhase 1NCT00022880
Safety and Efficacy Study of Iodine-131 Anti-B1 Antibody for Chronic Lymphocytic Leukemia
A Phase 1 study testing Iodine-131 Anti-B1 Antibody in people with Chronic Lymphocytic Leukemia, run by Corixa Corporation at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia
- What is being tested?
- Iodine-131 Anti-B1 Antibody
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 1999to not given
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Long Island Jewish Medical Center
New Hyde Park, New York, 11041
Stanford University Medical Center
Palo Alto, California, 94305
About this study
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
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.
Read the 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.
- Conditions
- Chronic Lymphocytic Leukemia
- Being tested
- Iodine-131 Anti-B1 Antibody
- Keywords
- Chronic Lymphocytic Leukemia, Dose-Escalation, Radioimmunotherapy, Monoclonal Antibody, Corixa, Bexxar, Anti-B1 Antibody, Tositumomab, Iodine -131 Anti-B1 Antibody, Iodine I 131 Tositumomab
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iodine-131 Anti-B1 AntibodyDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2001 (estimated)
- Study startJul 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Corixa Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00022880
- Sponsor's protocol ID
- CP-98-018
- Status last verified
- Aug 2004
- First submitted
- 15 Aug 2001
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00022880
- Acronym / sponsor ID
- CP-98-018
- Conditions
- Chronic Lymphocytic Leukemia
- Keywords
- Chronic Lymphocytic Leukemia, Dose-Escalation, Radioimmunotherapy, Monoclonal Antibody, Corixa, Bexxar, Anti-B1 Antibody, Tositumomab
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants
- Lead sponsor
- Corixa CorporationIndustry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Study start
- Jul 1999
- First posted
- 17 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iodine-131 Anti-B1 Antibody | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Iodine-131 Anti-B1 Antibody in people with Chronic Lymphocytic Leukemia, run by Corixa Corporation at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.