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NCT01269385 · ClinicalTrials.gov registry record · Phase 1
Imprime PGG, Alemtuzumab, and Rituximab in Treating Patients With High Risk Chronic Lymphocytic Leukemia
A Phase 1 study of Refractory Chronic Lymphocytic Leukemia and B-cell Chronic Lymphocytic Leukemia, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
- 1
- Study location
NCT01269385 is a Phase 1 study of Refractory Chronic Lymphocytic Leukemia and B-cell Chronic Lymphocytic Leukemia that has completed, run by Mayo Clinic. The registered enrollment target is 22 participants, below the 60-participant average among 19 other Refractory Chronic Lymphocytic Leukemia trials with a reported enrollment target (63% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01269385, a Phase 1 study of Refractory Chronic Lymphocytic Leukemia and B-cell Chronic Lymphocytic Leukemia, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
- 1
- Study location
Study Summary
RATIONALE: Monoclonal antibodies, such as alemtuzumab and rituximab, can kill chronic lymphocytic leukemia (CLL) cells and are effective therapies for this disease. Biological therapies, such as Imprime PGG (poly-(1-6)-beta-glucotriosyl-(1-3)-beta-glucopyranose), may stimulate the immune system in different ways and help monoclonal antibodies kill CLL cells. Giving PGG beta-glucan together with alemtuzumab and rituximab could make therapy with monoclonal antibodies, such as alemtuzumab and rituximab, more effective. PURPOSE: This phase I/II trial is studying the side effects and best dose of PGG beta-glucan when given together with alemtuzumab and rituximab and to see how well it works in treating patients with earlier stage high-risk chronic lymphocytic leukemia.
Conditions Studied
Interventions
- OTHER laboratory biomarker analysis
- BIOLOGICAL rituximab
- BIOLOGICAL alemtuzumab
- OTHER flow cytometry
- DRUG PGG beta-glucan
Study Locations (1)
Minnesota
- Mayo Clinic - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2011-01 |
| Est. Completion | 2015-06 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01269385
The ClinicalTrials.gov registry entry for NCT01269385 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 60-participant average among 19 other Refractory Chronic Lymphocytic Leukemia trials with a reported enrollment target (63% lower). The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Refractory Chronic Lymphocytic Leukemia appearing as the primary indexed condition, and to 5 interventions - of which laboratory biomarker analysis is the first listed.
NCT01269385 reports 1 study location spanning 1 distinct geographic area - top geographies include Minnesota.
Frequently Asked Questions
What is clinical trial NCT01269385 about?
NCT01269385 is a clinical study titled "Imprime PGG, Alemtuzumab, and Rituximab in Treating Patients With High Risk Chronic Lymphocytic Leukemia". RATIONALE: Monoclonal antibodies, such as alemtuzumab and rituximab, can kill chronic lymphocytic leukemia (CLL) cells and are effective therapies for this disease. Biological therapies, such as Imprime PGG (poly-(1-6)-beta-glucotriosyl-(1-3)-beta-glucopyranose), may stimulate the immune system in d...
What is the current status of trial NCT01269385?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2011-01. Estimated completion is 2015-06.
What conditions does trial NCT01269385 study?
This clinical trial studies the following conditions: Refractory Chronic Lymphocytic Leukemia, B-cell Chronic Lymphocytic Leukemia, Stage I Chronic Lymphocytic Leukemia, Stage II Chronic Lymphocytic Leukemia, Stage 0 Chronic Lymphocytic Leukemia.
What interventions are being tested in trial NCT01269385?
The interventions under investigation include: laboratory biomarker analysis (OTHER), rituximab (BIOLOGICAL), alemtuzumab (BIOLOGICAL), flow cytometry (OTHER), PGG beta-glucan (DRUG).
Who is sponsoring clinical trial NCT01269385?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01269385 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.