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NCT00176852 · ClinicalTrials.gov registry record · Phase 2
Stem Cell Transplant for Hemoglobinopathy
A Phase 2 study of Sickle Cell Disease and Thalassemia, sponsored by Masonic Cancer Center, University of Minnesota.
- Completed
- Registry status
- Phase 2
- Development phase
- 22
- Enrollment target
- 1
- Study location
NCT00176852: Completed Phase 2 study of Sickle Cell Disease and Thalassemia, sponsored by Masonic Cancer Center, University of Minnesota.
NCT00176852 is a Phase 2 study of Sickle Cell Disease and Thalassemia that has completed, run by Masonic Cancer Center, University of Minnesota. The registered enrollment target is 22 participants, below the 293-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00176852, a Phase 2 study of Sickle Cell Disease and Thalassemia, has completed, sponsored by Masonic Cancer Center, University of Minnesota.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 22 participants
- Enrollment target
- 1
- Study location
Study Summary
This study tests the clinical outcomes of one of two preparative regimens (determined by available donor source) in patients with non-malignant hemoglobinopathies. The researchers hypothesize that these regimens will have a positive effect on post transplant engraftment and the incidence of graft-versus-host-disease. Regimen A2 has replaced Regimen A in this study. Two patients were treated on Regimen A but did not have evidence of initial engraftment thus triggering the stopping rule for that arm of this study.
Primary Outcome
In general, grade 3 equates to moderate, grade 4 to severe and grade 5 to death.
Conditions Studied
Interventions
- RADIATION Total Body Irradiation
- PROCEDURE Stem cell infusion
- DRUG Busulfan, Fludarabine, ATG, TLI
- DRUG Busulfan, Cyclophosphamide, ATG, GCSF
- DRUG Campath, Fludarabine, Cyclophosphamide
Study Locations (1)
Minnesota
- Masonic Cancer Center, University of Minnesota - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2002-06 |
| Est. Completion | 2020-01 |
| Phase | Phase 2 |
What the finished NCT00176852 record still lists
NCT00176852 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 293-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (92% lower).
The record links to 5 conditions, with Sickle Cell Disease appearing as the primary indexed condition, and to 5 interventions - of which Total Body Irradiation is the first listed.
NCT00176852 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT00176852 about?
NCT00176852 is a clinical study titled "Stem Cell Transplant for Hemoglobinopathy". This study tests the clinical outcomes of one of two preparative regimens (determined by available donor source) in patients with non-malignant hemoglobinopathies. The researchers hypothesize that these regimens will have a positive effect on post transplant engraftment and the incidence of graft-ve...
What is the current status of trial NCT00176852?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 2002-06. Estimated completion is 2020-01.
What conditions does trial NCT00176852 study?
This clinical trial studies the following conditions: Sickle Cell Disease, Thalassemia, Diamond-Blackfan Anemia, Shwachman-Diamond Syndrome, Severe Congenital Neutropenia.
What interventions are being tested in trial NCT00176852?
The interventions under investigation include: Total Body Irradiation (RADIATION), Stem cell infusion (PROCEDURE), Busulfan, Fludarabine, ATG, TLI (DRUG), Busulfan, Cyclophosphamide, ATG, GCSF (DRUG), Campath, Fludarabine, Cyclophosphamide (DRUG).
Who is sponsoring clinical trial NCT00176852?
This trial is sponsored by Masonic Cancer Center, University of Minnesota, which has 249 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00176852 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
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Where NCT00176852's enrollment target sits among peer trials
22 166th of 213 higher than 46 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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