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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: Completed Phase 2 study of Leukemia and Non-Hodgkin's Lymphoma, sponsored by David Rizzieri, MD.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Estimate disease free survival rates in participants treated with an alemtuzumab T cell depleted, reduced intensity preparative regimen followed by allogeneic hematopoietic transplantation. Disease-free survival (DFS), progression-free survival (PFS), and overall survival (OS) rates after SCT were estimated using the Kaplan-Meier method. We performed univariate comparisons by using the log-rank test. DFS was defined as the period of time between the day of transplantation and either disease rela
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 |
What the finished NCT00597714 record still lists
NCT00597714 is an interventional study that assigns participants to a tested intervention. The registered 264 participants enrollment target is mid-sized for trials with a published cap, below the 486-participant average among 233 other Leukemia trials with a reported enrollment target (46% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT00597714's enrollment target sits among peer trials
264 34th of 233 higher than 200 of 233 other Leukemia trials
participants (enrollment target), bucketed by value
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