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NCT00076180 · ClinicalTrials.gov registry record · Phase 1
Hu-Mik-beta1 to Treat T-Cell Large Granular Lymphocytic Leukemia
A Phase 1 study of T-cell Large Granular Lymphocytic Leukemia and Leukemia, T-Cell Large Granular Lymphocytic, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
- 1
- Study location
NCT00076180: Completed Phase 1 study of T-cell Large Granular Lymphocytic Leukemia and Leukemia, T-Cell Large Granular Lymphocytic, sponsored by National Cancer Institute (NCI).
NCT00076180 is a Phase 1 study of T-cell Large Granular Lymphocytic Leukemia and Leukemia, T-Cell Large Granular Lymphocytic that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 9 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00076180, a Phase 1 study of T-cell Large Granular Lymphocytic Leukemia and Leukemia, T-Cell Large Granular Lymphocytic, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will examine the use of the humanized Mik-beta-1 (Hu-Mik-beta1) antibody in patients with T-cell large granular lymphocytic leukemia (T-LGL). Patients with T-LGL often have reduced white blood cells, red blood cells, and platelets, and increased numbers of abnormal cells called large granular lymphocytes (LGLs). Patients may have recurrent infections, anemia, or abnormal bleeding. Hu-Mik-beta1 attaches to LGL cells and blocks the action of growth factors called interleukins that stimulate LGL growth. Blocking these interleukins may stop T-LGL leukemia cells from growing. This study will determine the dose and frequency of treatment with Hu-Mik-(SqrRoot) 1 that can safely be given to patients to coat the surface of their leukemic cells with antibody, determine how long the antibody lasts in the blood after injection, and examine the side effects and possible benefits of the drug in these patients. Patients age 18 or older with T-LGL may be eligible for this study. Candidates will be screened with a medical history and physical examination, review of pathology studies, skin biopsy, evaluation of rheumatoid arthritis if present, chest x-ray, computerized tomography (CT) scans and other imaging studies as needed, bone marrow biopsy, and blood and urine tests. Participants will receive a single dose of Hu-Mik-beta1 by a 90-minute infusion through a vein. Groups of patients will be treated with increasing doses (0.5, 1.0, and 1.5 mg/kg) of the antibody. Patients who develop serious drug side effects are taken off the study. The treatment requires a 3- to 4-day hospital stay. In addition to Hu-Mik-(SqrRoot) 1 treatment, patients will undergo the following tests and procedures: * Collection of blood for 8 days following the dose of Hu-Mik-beta1 to measure blood levels of the antibody. * Follow-up visits of 1 to 2 days at 22, 29, and 43 days after the dose of the antibody and then every 3 months for a total of 9 months. * Bone marrow aspirate and biopsy if one
Primary Outcome
Adverse events will be tabulated/reported by type, grade, and frequency.
Conditions Studied
Interventions
- BIOLOGICAL Hu-MiK-Beta-1
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2004-03-01 |
| Est. Completion | 2019-01-09 |
| Phase | Phase 1 |
What the finished NCT00076180 record still lists
NCT00076180 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower).
The record links to 2 conditions, with T-cell Large Granular Lymphocytic Leukemia appearing as the primary indexed condition, and to 1 intervention - of which Hu-MiK-Beta-1 is the first listed.
NCT00076180 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT00076180 about?
NCT00076180 is a clinical study titled "Hu-Mik-beta1 to Treat T-Cell Large Granular Lymphocytic Leukemia". This study will examine the use of the humanized Mik-beta-1 (Hu-Mik-beta1) antibody in patients with T-cell large granular lymphocytic leukemia (T-LGL). Patients with T-LGL often have reduced white blood cells, red blood cells, and platelets, and increased numbers of abnormal cells called large gran...
What is the current status of trial NCT00076180?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2004-03-01. Estimated completion is 2019-01-09.
What conditions does trial NCT00076180 study?
This clinical trial studies the following conditions: T-cell Large Granular Lymphocytic Leukemia, Leukemia, T-Cell Large Granular Lymphocytic.
What interventions are being tested in trial NCT00076180?
The interventions under investigation include: Hu-MiK-Beta-1 (BIOLOGICAL).
Who is sponsoring clinical trial NCT00076180?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00076180 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00076180's enrollment target sits among peer trials
9 1955th of 2000 higher than 42 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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