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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: Completed Phase 1 study of Refractory Chronic Lymphocytic Leukemia and B-cell Chronic Lymphocytic Leukemia, sponsored by Mayo Clinic.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
MTD is defined as the dose level below the lowest dose that induces dose-limiting toxicity (DLT) in at least one-third of patients (at least 2 of a maximum of 6 new patients). A total of 6 patients treated at the MTD will be sufficient to identify common toxicities at the MTD. Three patients will be treated at a given dose level combination for at least 5 weeks to assess toxicity. If dose-limiting toxicity (DLT) is not seen in any of the 3 patients, 3 new patients will be accrued and treated at
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 |
What the finished NCT01269385 record still lists
NCT01269385 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 60-participant average among 19 other Refractory Chronic Lymphocytic Leukemia trials with a reported enrollment target (63% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Refractory Chronic Lymphocytic Leukemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01269385's enrollment target sits among peer trials
22 12th of 19 higher than 7 of 19 other Refractory Chronic Lymphocytic Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Refractory Chronic Lymphocytic Leukemia 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.
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