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NCT00321555 · ClinicalTrials.gov registry record · Phase 2
LMB-2 to Treat Hairy Cell Leukemia
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 15
- Enrollment target
NCT00321555: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT00321555 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 15 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00321555, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 15 participants
- Enrollment target
Study Summary
Background: * About 80% of patients with hairy cell leukemia (HCL) have tumor cells that have a protein on their surface called cluster of differentiation 25 (CD25). * The experimental drug LMB-2 is a recombinant immunotoxin that has been shown to kill leukemia and lymphoma cells with the CD25 protein. (A recombinant immunotoxin is a genetically engineered drug that has two parts - a protein that binds or targets a cancer cell, and a toxin that kills the cancer cell to which it binds.) Objectives: * To evaluate the safety and effectiveness of LMB-2 in patients with HCL whose cancer cells contain the CD25 protein. * To evaluate the effects of LMB-2 on the immune system, determine how the drug is metabolized by the body and examine its side effects. Eligibility: -Adults with hairy cell leukemia whose tumor cells have CD25 on their surface Design: * Up to 27 patients may be included in the study. * Patients receive an infusion of LMB-2 through a vein every other day for three doses (days 1, 3, 5), constituting one treatment cycle. * Patients may receive up to six treatment cycles every 4 weeks unless their cancer worsens or they develop unacceptable side effects. * Blood is drawn weekly for various tests. * Before each cycle and in follow-up visits, disease status is evaluated with a physical examination, blood tests, chest x-ray and electrocardiogram. * Before the first cycle, patients may have a computed tomography (CT) scan, echocardiogram (heart ultrasound test) and bone marrow biopsy. With the patient's permission, these tests may be repeated before other cycles also.
Interventions
- DRUG Anti-Tac(Fv)-PE38 (LMB-2) Immunotoxin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2006-05-02 |
| Est. Completion | 2022-12-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00321555
The ClinicalTrials.gov registry entry for NCT00321555 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 15 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 1 intervention - of which Anti-Tac(Fv)-PE38 (LMB-2) Immunotoxin is the first listed.
NCT00321555 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00321555 about?
NCT00321555 is a clinical study titled "LMB-2 to Treat Hairy Cell Leukemia". Background: * About 80% of patients with hairy cell leukemia (HCL) have tumor cells that have a protein on their surface called cluster of differentiation 25 (CD25). * The experimental drug LMB-2 is a recombinant immunotoxin that has been shown to kill leukemia and lymphoma cells with the CD25 prot...
What is the current status of trial NCT00321555?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2006-05-02. Estimated completion is 2022-12-31.
What interventions are being tested in trial NCT00321555?
The interventions under investigation include: Anti-Tac(Fv)-PE38 (LMB-2) Immunotoxin (DRUG).
Who is sponsoring clinical trial NCT00321555?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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