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NCT00061048 · ClinicalTrials.gov registry record · Phase 2
Campath-1H for Treating Adult T-Cell Leukemia/Lymphoma
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 29
- Enrollment target
NCT00061048: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT00061048 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 29 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00061048, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 29 participants
- Enrollment target
Study Summary
This study will examine the safety and effectiveness of Alemtuzumab (Campath-1H) for treating patients with adult T-cell leukemia/lymphoma (ATL). ATL is caused by a virus called human T-cell lymphotrophic virus type-1 (HTLV-1) that infects lymphocytes (white blood cells) called T-cells. Cancerous cells can be found not only in the blood, but also in the skin, lungs, lymph nodes, liver, bone, bone marrow, spleen, and meninges (tissues covering the brain). There are four categories of ATL, based on the aggressiveness of disease-smoldering, chronic, lymphoma, and acute. Campath-1H is a monoclonal antibody that attaches to and kills normal and cancerous lymphocytes, including T cells. Although Campath-1H is an experimental drug for treating ATL, it is approved by the Food and Drug Administration for treating chronic lymphocytic leukemia. Patients 18 years of age and older with any type of ATL except smoldering may be eligible for this study. Candidates are screened with a medical history and physical examination, photos of skin lesions, measurement of lesions such as lymph nodes and skin nodules, blood and urine tests, electrocardiogram (EKG), chest x-ray, computed tomography (CT) scan or ultrasound of the abdomen, skin biopsy, bone marrow aspirate and biopsy, skin test, and lumbar puncture (spinal tap). Participants undergo treatment in two phases, as follows: * Dose escalation phase: Patients receive an infusion of Campath-1H daily for three days. The initial dose is low and is increased daily as long as there are no side effects, or only mild reactions, until the patient is receiving the maximum dose of 30 milligrams per day. * Stable dose phase: Patients receive infusions of Campath-1H 30 mg three times a week for up to 12 weeks. In addition to treatment, patients are evaluated with the following tests and procedures: * History and physical examination every 4 weeks. * Blood tests every 4 weeks. * CT scans to measure the size of the tumors every 4 weeks. * Skin
Interventions
- BIOLOGICAL Alemtuzumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2003-05 |
| Est. Completion | 2012-07 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00061048
The ClinicalTrials.gov registry entry for NCT00061048 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 29 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 Alemtuzumab is the first listed.
NCT00061048 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00061048 about?
NCT00061048 is a clinical study titled "Campath-1H for Treating Adult T-Cell Leukemia/Lymphoma". This study will examine the safety and effectiveness of Alemtuzumab (Campath-1H) for treating patients with adult T-cell leukemia/lymphoma (ATL). ATL is caused by a virus called human T-cell lymphotrophic virus type-1 (HTLV-1) that infects lymphocytes (white blood cells) called T-cells. Cancerous ce...
What is the current status of trial NCT00061048?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 29 participants. The study started on 2003-05. Estimated completion is 2012-07.
What interventions are being tested in trial NCT00061048?
The interventions under investigation include: Alemtuzumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT00061048?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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