Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00553098 · ClinicalTrials.gov registry record · Phase 2
Alemtuzumab, Fludarabine Phosphate, and Total-Body Irradiation Followed by a Donor Stem Cell Transplant in Treating Patients With Immunodeficiency or Other Nonmalignant Inherited Disorders
A Phase 2 study, sponsored by Fred Hutchinson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 29
- Enrollment target
NCT00553098: Completed Phase 2 study, sponsored by Fred Hutchinson Cancer Center.
NCT00553098 is a Phase 2 study that has completed, run by Fred Hutchinson Cancer Center. The registered enrollment target is 29 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00553098, a Phase 2 study, has completed, sponsored by Fred Hutchinson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 29 participants
- Enrollment target
Study Summary
This phase II trial studies fludarabine phosphate and total-body irradiation with or without alemtuzumab followed by donor stem cell transplant to see how well it works in treating patients with immunodeficiency or other nonmalignant inherited disorders. Giving chemotherapy, such as fludarabine phosphate, a monoclonal antibody such as alemtuzumab, and radiation therapy before a donor stem cell transplant helps stop the growth of abnormal cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining abnormal cells.
Primary Outcome
The study will be considered a success and the protocol worthy of further study if there is sufficient evidence that this rate is greater than the 50% rate observed in the most recently transplanted patients with nonmalignant disorders. Analyses will be carried out separately for the alemtuzumab recipients and the TBI recipients. We will be 80% confidence of success if a one-sided 80% confidence interval for the proportion of patients with successful chimerism exceeds 50%. Cumulative incidence w
Interventions
- DRUG Fludarabine Phosphate
- DRUG Cyclosporine
- PROCEDURE Allogeneic Hematopoietic Stem Cell Transplantation
- BIOLOGICAL Alemtuzumab
- PROCEDURE Allogeneic Bone Marrow Transplantation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2006-06 |
| Phase | Phase 2 |
What the finished NCT00553098 record still lists
NCT00553098 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 5 interventions - of which Fludarabine Phosphate is the first listed.
NCT00553098 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00553098 about?
NCT00553098 is a clinical study titled "Alemtuzumab, Fludarabine Phosphate, and Total-Body Irradiation Followed by a Donor Stem Cell Transplant in Treating Patients With Immunodeficiency or Other Nonmalignant Inherited Disorders". This phase II trial studies fludarabine phosphate and total-body irradiation with or without alemtuzumab followed by donor stem cell transplant to see how well it works in treating patients with immunodeficiency or other nonmalignant inherited disorders. Giving chemotherapy, such as fludarabine phos...
What is the current status of trial NCT00553098?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 29 participants. The study started on 2006-06.
What interventions are being tested in trial NCT00553098?
The interventions under investigation include: Fludarabine Phosphate (DRUG), Cyclosporine (DRUG), Allogeneic Hematopoietic Stem Cell Transplantation (PROCEDURE), Alemtuzumab (BIOLOGICAL), Allogeneic Bone Marrow Transplantation (PROCEDURE).
Who is sponsoring clinical trial NCT00553098?
This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00553098's enrollment target sits among peer trials
29 1669th of 2000 higher than 324 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02429557 · 29 participants · Phase 1
Hemodynamic Mechanisms of Abdominal Compression in the Treatment of Orthostatic Hypotension in Autonomic Failure
- NCT02568878 · 29 participants · Phase 3
Creatine for Depressed Male and Female Methamphetamine Users
- NCT03014401 · 29 participants · NA
The Effect of Adipose-Derived Stem Cells for Knee Osteoarthritis
- NCT03128996 · 29 participants · Phase 1
Reduced Intensity Conditioning and Familial HLA-Mismatched BMT for Non-Malignant Disorders
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia