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NCT00597714 · ClinicalTrials.gov registry record · Phase 2
Efficacy Study of T Cell Depleted Allogeneic Non-myeloablative Stem Cell Transplant
A Phase 2 study of Leukemia and Non-Hodgkin's Lymphoma, sponsored by David Rizzieri, MD.
- Completed
- Registry status
- Phase 2
- Development phase
- 264
- Enrollment target
- 1
- Study location
NCT00597714 is a Phase 2 study of Leukemia and Non-Hodgkin's Lymphoma that has completed, run by David Rizzieri, MD. The registered enrollment target is 264 participants, below the 486-participant average among 233 other Leukemia trials with a reported enrollment target (46% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00597714, a Phase 2 study of Leukemia and Non-Hodgkin's Lymphoma, has completed, sponsored by David Rizzieri, MD.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 264 participants
- Enrollment target
- 1
- Study location
Study Summary
The central hypothesis of this study is that use of a less toxic chemotherapy preparative regimen for allogeneic hematopoietic stem cell transplantation in combination with T cell depletion with alemtuzumab for patients with high risk hematologic malignancies will allow effective control of disease and improved disease free and overall survival compared with historical expectations. Specifically, the objectives are to estimate toxicity, disease free, progression free, event free, and overall survival rates in patients treated with alemtuzumab T cell depleted, reduced intensity preparative regimen followed by allogeneic hematopoietic transplantation; evaluate immune recovery following this reduced intensity allogeneic immunotherapy; develop an in vitro assay to allow patient individualized targeted dosing.
Conditions Studied
Interventions
- DRUG Non-myeloablative Stem Cell Transplantation
Study Locations (1)
North Carolina
- Duke University Health System - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 264 participants |
| Start Date | 2008-02 |
| Est. Completion | 2013-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00597714
The ClinicalTrials.gov registry entry for NCT00597714 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 264 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 486-participant average among 233 other Leukemia trials with a reported enrollment target (46% lower). The listed sponsor is David Rizzieri, MD, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Leukemia appearing as the primary indexed condition, and to 1 intervention - of which Non-myeloablative Stem Cell Transplantation is the first listed.
NCT00597714 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT00597714 about?
NCT00597714 is a clinical study titled "Efficacy Study of T Cell Depleted Allogeneic Non-myeloablative Stem Cell Transplant". The central hypothesis of this study is that use of a less toxic chemotherapy preparative regimen for allogeneic hematopoietic stem cell transplantation in combination with T cell depletion with alemtuzumab for patients with high risk hematologic malignancies will allow effective control of disease ...
What is the current status of trial NCT00597714?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 264 participants. The study started on 2008-02. Estimated completion is 2013-11.
What conditions does trial NCT00597714 study?
This clinical trial studies the following conditions: Leukemia, Non-Hodgkin's Lymphoma, Myeloma, Hodgkin's Disease, Myelodysplasia.
What interventions are being tested in trial NCT00597714?
The interventions under investigation include: Non-myeloablative Stem Cell Transplantation (DRUG).
Who is sponsoring clinical trial NCT00597714?
This trial is sponsored by David Rizzieri, MD, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00597714 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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