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NCT00153985 · ClinicalTrials.gov registry record · Phase 2
Allogeneic Stem Cell Transplantation Following Chemotherapy in Patients With Hemoglobinopathies
A Phase 2 study of Sickle Cell Disease and Thalassemia, sponsored by Dana-Farber Cancer Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 2
- Enrollment target
- 6
- Study locations
NCT00153985: Completed Phase 2 study of Sickle Cell Disease and Thalassemia, sponsored by Dana-Farber Cancer Institute.
NCT00153985 is a Phase 2 study of Sickle Cell Disease and Thalassemia that has completed, run by Dana-Farber Cancer Institute. The registered enrollment target is 2 participants, below the 293-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (99% lower). The trial reports 6 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00153985, a Phase 2 study of Sickle Cell Disease and Thalassemia, has completed, sponsored by Dana-Farber Cancer Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 2 participants
- Enrollment target
- 6
- Study locations
Study Summary
The purpose of this study is to determine if treatment with reduced-dose busulfex, fludarabine and alemtuzumab (CAMPATH) followed by sten cell infusion will allow for donor stem cells to grow in patients with hemoglobinopathies bone marrow and restore circulating blood counts. In addition the incidence and severity of side effects and of graft vs. host disease (GVHD) will be monitored.
Primary Outcome
Outcome was measured by ANC \>500 for three consecutive days prior to day 30 after PBSC infusion, \>25% of hematopoietic cells are donor derived as determined by molecular chimerism assays or cytogenetic methods prior to day 45 after PBSC infusion and \>25% of hematopoietic cells are donor derived as determined by molecular chimerism assays or cytogenetic methods after day 180 after PBSC infusion.
Conditions Studied
Interventions
- DRUG Fludarabine
- DRUG Alemtuzumab
- DRUG Busulfex
- PROCEDURE Stem Cell Transfusion
Study Locations (6)
Massachusetts
- Beth Israel Deaconess Medical Center - Boston
- Dana-Farber Cancer Institute - Boston
- Massachusetts General Hospital - Boston
Georgia
- Winship Cancer Institute-Emory University - Atlanta
Louisiana
- Feist-Weiller Cancer Center-LSU - Shreveport
Ohio
- Ohio State University College of Medicine - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2004-03 |
| Est. Completion | 2009-07 |
| Phase | Phase 2 |
What the finished NCT00153985 record still lists
NCT00153985 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 293-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (99% lower).
The record links to 3 conditions, with Sickle Cell Disease appearing as the primary indexed condition, and to 4 interventions - of which Fludarabine is the first listed.
NCT00153985 lists 6 locations in 4 states (Massachusetts, Georgia, Louisiana).
Frequently Asked Questions
What is clinical trial NCT00153985 about?
NCT00153985 is a clinical study titled "Allogeneic Stem Cell Transplantation Following Chemotherapy in Patients With Hemoglobinopathies". The purpose of this study is to determine if treatment with reduced-dose busulfex, fludarabine and alemtuzumab (CAMPATH) followed by sten cell infusion will allow for donor stem cells to grow in patients with hemoglobinopathies bone marrow and restore circulating blood counts. In addition the incide...
What is the current status of trial NCT00153985?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 2 participants. The study started on 2004-03. Estimated completion is 2009-07.
What conditions does trial NCT00153985 study?
This clinical trial studies the following conditions: Sickle Cell Disease, Thalassemia, Hemoglobinopathies.
What interventions are being tested in trial NCT00153985?
The interventions under investigation include: Fludarabine (DRUG), Alemtuzumab (DRUG), Busulfex (DRUG), Stem Cell Transfusion (PROCEDURE).
Who is sponsoring clinical trial NCT00153985?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00153985 being conducted?
This trial has 6 study locations across Georgia, Louisiana, Massachusetts, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00153985's enrollment target sits among peer trials
2 213th of 213 the lowest of 213 other Sickle Cell Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sickle Cell Disease 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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