Non-Hodgkin's LymphomaPhase 2NCT00022932
Safety and Efficacy of Iodine-131 Anti-B1 Antibody for Intermediate Grade Non-Hodgkin's Lymphoma Following First Line CHOP
A Phase 2 study testing Iodine-131 Anti-B1 Antibody in people with Non-Hodgkin's Lymphoma, run by Corixa Corporation at 3 sites in United States.
Trial summary
The purpose of this study is to determine the safety and effectiveness of using Iodine-131 Anti-B1 Antibody for the treatment of patients with large B-cell non-Hodgkin's lymphoma (NHL) who have achieved a response following 6-8 cycles of CHOP therapy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non-Hodgkin's Lymphoma
- What is being tested?
- Iodine-131 Anti-B1 Antibody
- How many people
- Not given
- Where
- 3 sitesUnited States
- Study dates
- Jan 2000to not given
- Phase
- Phase 2
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have a histologically confirmed initial diagnosis of de novo diffuse large B-cell NHL according to the REAL classification. This includes the intermediate grade International Working Formulation subtypes of diffuse, mixed small cell and large cell; diffuse large cell; follicular large cell; mantle cell, and large cell immunoblastic.
- Patients must have had Ann Arbor, stage III or stage IV, or bulky Stage II disease at diagnosis.
- Patients must be less than or equal to 80 years of age with any IPI score.
- Patients must have less than an average of 25% of the intratrabecular marrow space involved by NHL in bilateral bone marrow biopsy specimens as assessed microscopically at study entry. A unilateral bone marrow biopsy demonstrating <10% involvement with NHL is also adequate. Verification of bone marrow status must be performed at the time of response evaluation following CHOP chemotherapy and within 56 days of study enrollment.
- Patients must have been treated with 6 or more cycles of first-line CHOP chemotherapy and have achieved a PR, CRu, or CR. Patients must have available computed tomography (CT) scans of the chest, abdomen, and pelvis, and a bone marrow biopsy that were performed within 56 days prior to the start of CHOP. In addition, they must have written documentation (i.e., copies of original medical notes and radiographic reports) describing the pre-CHOP staging evaluation, the number of cycles of CHOP administered, the dose of each agent, the start and stop dates of each cycle, and the post-CHOP response evaluation. The post-CHOP response evaluation must include a CT scan of the chest, abdomen, and pelvis (gallium scan is optional). For patients who have palpable cervical lymphadenopathy, a CT scan of the neck must be performed following CHOP chemotherapy. The CHOP chemotherapy should consist of standard doses of each agent, although dose-reduction is permitted. CHOP cycle delay is also permitted.
- The patient must be enrolled within 56 days of the first day of the last cycle of CHOP chemotherapy and within 35 days following response evaluation after CHOP chemotherapy.
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- Patients must have evidence that their tumor tissue expresses the CD20 antigen.
- Patients must have a performance status of at least 60% on the Karnofsky Performance Scale and an anticipated survival of at least 3 months.
- Patients must have an ANC greater than or equal to 1500 cells/mm3 and a platelet count greater than or equal to 100,000 cells/mm3 within 14 days of study enrollment. These blood counts must be sustained without support of hematopoietic cytokines or transfusion of blood products.
- Patients must have adequate renal function (defined as serum creatinine <1.5 times the upper limit of normal) and hepatic function (defined as total bilirubin less than or equal to 2.0 times the upper limit of normal and AST <5 times the upper limit of normal) within 20 days of study enrollment.
- Patients of childbearing potential must undergo a negative serum pregnancy test within 14 days prior to study enrollment
Who cannot join
- Patients who have received prior chemotherapy other than first-line CHOP. Patients must not have been treated with radiation, or biological therapy prior to or after CHOP chemotherapy.
- Patients with active bilateral obstructive hydronephrosis.
- 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 who have been disease-free of another cancer for greater than 5 years must be carefully assessed at the time of study enrollment to rule out recurrent disease.
- Patients with known HIV infection.
- Patients who are HAMA positive.
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- Patients with known brain or leptomeningeal metastases at any time since diagnosis.
- Patients with active infection requiring IV anti-infectives at the time of study enrollment.
- Patients who are pregnant or breastfeeding. Males and females must agree to use a contraceptive method from enrollment to 6 months after receiving Iodine-131 Anti-B1 Antibody.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Tufts New England Medical Center
Boston, Massachusetts, 02111
Rush Medical Center
Chicago, Illinois, 60612
Cornell Medical Center
New York, New York, 10021
About this study
Official title: Phase II Multicenter Study of Iodine-131 Anti-B1 Antibody Consolidation For Patients With Diffuse Large B-Cell Non-Hodgkin's Lymphoma Following First-Line CHOP
The purpose of this study is to determine the safety and effectiveness of using Iodine-131 Anti-B1 Antibody for the treatment of patients with large B-cell non-Hodgkin's lymphoma (NHL) who have achieved a response following 6-8 cycles of CHOP therapy.
Read the detailed description
The primary endpoint is to determine the incidence of Grade IV hematologic toxicity following Iodine-131 Anti-B1 Antibody consolidation for patients with diffuse large B-cell NHL who achieved a response (PR, CRu, CR) following first-line CHOP chemotherapy. The secondary efficacy endpoints are to determine the complete response rate, duration of response, duration of complete response, progression-free survival, and time to treatment failure. The pharmacokinetic endpoint is to determine the total body residence time following the dosimetric dose. The secondary safety endpoints are to determine the incidence of adverse experiences, hematologic toxicity (e.g., nadir, time to nadir, and time to recovery), use of supportive care, percent of patients converting to human anti-murine antibody (HAMA) positivity, and survival.
- Conditions
- Non-Hodgkin's Lymphoma
- Being tested
- Iodine-131 Anti-B1 Antibody
- Keywords
- Non-Hodgkin's Lymphoma, Radioimmunotherapy, Monoclonal Antibody, Corixa, Bexxar, Anti-B1 Antibody, Tositumomab, Iodine -131 Anti-B1 Antibody, Iodine I 131 Tositumomab
- Medical subject headings
- Lymphoma, Non-Hodgkin
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 posted20 Aug 2001 (estimated)
- Study startJan 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Hodgkin's LymphomaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Corixa Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00022932
- Sponsor's protocol ID
- CP-99-032
- Status last verified
- Sep 2004
- First submitted
- 16 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
- Phase II Multicenter Study of Iodine-131 Anti-B1 Antibody Consolidation For Patients With Diffuse Large B-Cell Non-Hodgkin's Lymphoma Following First-Line CHOP
- ClinicalTrials.gov ID
- NCT00022932
- Acronym / sponsor ID
- CP-99-032
- Conditions
- Non-Hodgkin's Lymphoma
- Keywords
- Non-Hodgkin's Lymphoma, Radioimmunotherapy, Monoclonal Antibody, Corixa, Bexxar, Anti-B1 Antibody, Tositumomab, Iodine -131 Anti-B1 Antibody
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Corixa CorporationIndustry (pharma, biotech, devices)
- Study start
- Jan 2000
- First posted
- 20 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 determine the safety and effectiveness of using Iodine-131 Anti-B1 Antibody for the treatment of patients with large B-cell non-Hodgkin's lymphoma (NHL) who have achieved a response following 6-8 cycles of CHOP therapy.
Detailed description
The primary endpoint is to determine the incidence of Grade IV hematologic toxicity following Iodine-131 Anti-B1 Antibody consolidation for patients with diffuse large B-cell NHL who achieved a response (PR, CRu, CR) following first-line CHOP chemotherapy. The secondary efficacy endpoints are to determine the complete response rate, duration of response, duration of complete response, progression-free survival, and time to treatment failure. The pharmacokinetic endpoint is to determine the total body residence time following the dosimetric dose. The secondary safety endpoints are to determine the incidence of adverse experiences, hematologic toxicity (e.g., nadir, time to nadir, and time to recovery), use of supportive care, percent of patients converting to human anti-murine antibody (HAMA) positivity, and survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients must have a histologically confirmed initial diagnosis of de novo diffuse large B-cell NHL according to the REAL classification. This includes the intermediate grade International Working Formulation subtypes of diffuse, mixed small cell and large cell; diffuse large cell; follicular large cell; mantle cell, and large cell immunoblastic.
- Patients must have had Ann Arbor, stage III or stage IV, or bulky Stage II disease at diagnosis.
- Patients must be less than or equal to 80 years of age with any IPI score.
- Patients must have less than an average of 25% of the intratrabecular marrow space involved by NHL in bilateral bone marrow biopsy specimens as assessed microscopically at study entry. A unilateral bone marrow biopsy demonstrating <10% involvement with NHL is also adequate. Verification of bone marrow status must be performed at the time of response evaluation following CHOP chemotherapy and within 56 days of study enrollment.
- Patients must have been treated with 6 or more cycles of first-line CHOP chemotherapy and have achieved a PR, CRu, or CR. Patients must have available computed tomography (CT) scans of the chest, abdomen, and pelvis, and a bone marrow biopsy that were performed within 56 days prior to the start of CHOP. In addition, they must have written documentation (i.e., copies of original medical notes and radiographic reports) describing the pre-CHOP staging evaluation, the number of cycles of CHOP administered, the dose of each agent, the start and stop dates of each cycle, and the post-CHOP response evaluation. The post-CHOP response evaluation must include a CT scan of the chest, abdomen, and pelvis (gallium scan is optional). For patients who have palpable cervical lymphadenopathy, a CT scan of the neck must be performed following CHOP chemotherapy. The CHOP chemotherapy should consist of standard doses of each agent, although dose-reduction is permitted. CHOP cycle delay is also permitted.
Key exclusion criteria (9 listed)
- Patients who have received prior chemotherapy other than first-line CHOP. Patients must not have been treated with radiation, or biological therapy prior to or after CHOP chemotherapy.
- Patients with active bilateral obstructive hydronephrosis.
- 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 who have been disease-free of another cancer for greater than 5 years must be carefully assessed at the time of study enrollment to rule out recurrent disease.
- Patients with known HIV infection.
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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Iodine-131 Anti-B1 Antibody in people with Non-Hodgkin's Lymphoma, run by Corixa Corporation at 3 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 11 inclusion and 9 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 3 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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.