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NCT00935792 · ClinicalTrials.gov registry record · Phase 1
Everolimus and Alemtuzumab in Treating Patients With Recurrent Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
A Phase 1 study of Lymphocytic Leukemia, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
- 2
- Study locations
NCT00935792: Completed Phase 1 study of Lymphocytic Leukemia, sponsored by Mayo Clinic.
NCT00935792 is a Phase 1 study of Lymphocytic Leukemia that has completed, run by Mayo Clinic. The registered enrollment target is 28 participants, above the 22-participant average among 4 other Lymphocytic Leukemia trials with a reported enrollment target (27% higher). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00935792, a Phase 1 study of Lymphocytic Leukemia, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
- 2
- Study locations
Study Summary
RATIONALE: Everolimus may stop the growth of cancer cells by blocking some of the signaling molecules needed for cell growth. Monoclonal antibodies, such as alemtuzumab, can bind to and kill malignant lymphocytes. PURPOSE: This phase I/II trial is studying the side effects and best dose of everolimus when given together with alemtuzumab and will see how well they work in treating patients with recurrent chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL).
Primary Outcome
CR requires all of the following for a period of at least 2months:Absence of lymphadenopathy.No hepatomegaly or splenomegaly.Absence of constitutional symptoms.• Neutrophils\>1500/ul•Platelets\>100,000/ul • Hemoglobin \>11.0gm/dl• Peripheral blood lymphocytes \<4000/uLBonemarrow. normocellular with\<30%of nucleated cells being lymphocytes.PR requires two for 2+months.≥50%decrease in peripheral blood lymphocyte count from the pretreatment baseline value.≥ 50%reduction in the sum of the products o
Conditions Studied
Interventions
- DRUG everolimus
- DRUG alemtuzumab
Study Locations (2)
Arizona
- Mayo Clinic in Arizona - Scottsdale
Minnesota
- Mayo Clinic - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2009-07 |
| Est. Completion | 2015-12 |
| Phase | Phase 1 |
What the finished NCT00935792 record still lists
NCT00935792 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, above the 22-participant average among 4 other Lymphocytic Leukemia trials with a reported enrollment target (27% higher).
The record links to 1 condition, with Lymphocytic Leukemia appearing as the primary indexed condition, and to 2 interventions - of which everolimus is the first listed.
NCT00935792 reports a single indexed study location in Arizona, Minnesota.
Frequently Asked Questions
What is clinical trial NCT00935792 about?
NCT00935792 is a clinical study titled "Everolimus and Alemtuzumab in Treating Patients With Recurrent Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma". RATIONALE: Everolimus may stop the growth of cancer cells by blocking some of the signaling molecules needed for cell growth. Monoclonal antibodies, such as alemtuzumab, can bind to and kill malignant lymphocytes. PURPOSE: This phase I/II trial is studying the side effects and best dose of everolim...
What is the current status of trial NCT00935792?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2009-07. Estimated completion is 2015-12.
What conditions does trial NCT00935792 study?
This clinical trial studies the following conditions: Lymphocytic Leukemia.
What interventions are being tested in trial NCT00935792?
The interventions under investigation include: everolimus (DRUG), alemtuzumab (DRUG).
Who is sponsoring clinical trial NCT00935792?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00935792 being conducted?
This trial has 2 study locations across Arizona, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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