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NCT00022971 · ClinicalTrials.gov registry record · Phase 1
Combination Antibody Therapy for Relapsed Lymphoma and Chronic Lymphocytic Leukemia
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 1
- Development phase
- 35
- Enrollment target
NCT00022971: Clinical Trial Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT00022971 is a Phase 1 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 35 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00022971, a Phase 1 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 35 participants
- Enrollment target
Study Summary
This study will evaluate the safety and effectiveness of a combination of two antibodies, apolizumab and rituximab (Rituxan ), in treating B-cell lymphomas and chronic lymphocytic leukemia. Rituximab attaches to a molecule called CD20 on B-cell lymphomas and can cause significant shrinkage of these tumors in up to half of patients. However, it does not cure the lymphoma, which usually returns. Also, it is not as effective against leukemia. Apolizumab attaches to a protein called 1D10 on B-cell cancers and has also been able to shrink tumors in some patients. There is little experience apolizumab in patients with leukemia. This study will test whether the two antibodies together are more effective against these tumors than either one alone. Patients 18 years and older with B-cell lymphoma or chronic lymphocytic leukemia may be eligible for this study. Patients' leukemia or lymphoma cells must have both the CD20 and 1D10 antigen receptors and must have had at least one systemic treatment for their disease. Candidates are screened with a medical history and physical examination, blood and urine tests, electrocardiogram, x-rays and other imaging studies, and possibly a bone marrow aspirate (withdrawal of a small marrow sample through a needle inserted into the hip bone) and lumbar puncture (withdrawal of a small sample of cerebrospinal fluid-fluid that bathes the brain and spinal cord-through a needle placed between the bones in the lower back). Participants receive infusions of rituximab and apolizumab once a week for 4 weeks. The first patients in the study receive lower doses of apolizumab with standard doses of rituximab. If the apolizumab is well tolerated, subsequent patients are given higher doses. Patients are also given dexamethasone or another similar steroid, diphenhydramine (Benadryl ), and acetominophen (Tylenol ) to reduce reactions to the antibodies. After 4 weeks of treatment, patients are followed frequently to examine the response to treatment and ev
Interventions
- BIOLOGICAL Rituximab
- BIOLOGICAL Apolizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2001-08-15 |
| Est. Completion | 2017-03-17 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00022971
The ClinicalTrials.gov registry entry for NCT00022971 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Rituximab is the first listed.
NCT00022971 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00022971 about?
NCT00022971 is a clinical study titled "Combination Antibody Therapy for Relapsed Lymphoma and Chronic Lymphocytic Leukemia". This study will evaluate the safety and effectiveness of a combination of two antibodies, apolizumab and rituximab (Rituxan ), in treating B-cell lymphomas and chronic lymphocytic leukemia. Rituximab attaches to a molecule called CD20 on B-cell lymphomas and can cause significant shrinkage of these ...
What is the current status of trial NCT00022971?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 35 participants. The study started on 2001-08-15. Estimated completion is 2017-03-17.
What interventions are being tested in trial NCT00022971?
The interventions under investigation include: Rituximab (BIOLOGICAL), Apolizumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT00022971?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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