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NCT02435901 · ClinicalTrials.gov registry record · Phase 1
HSCT For Patients With High Risk Hemoglobinopathies Using Reduced Intensity
A Phase 1 study, sponsored by Northwell Health.
- Completed
- Registry status
- Phase 1
- Development phase
- 29
- Enrollment target
NCT02435901: Completed Phase 1 study, sponsored by Northwell Health.
NCT02435901 is a Phase 1 study that has completed, run by Northwell Health. The registered enrollment target is 29 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02435901, a Phase 1 study, has completed, sponsored by Northwell Health.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 29 participants
- Enrollment target
Study Summary
This study will evaluate the use of reduced intensity conditioning regimen in patients with high risk hemoglobinopathy Sickle Cell and B-Thalassemia Major in combination with standard immunosuppressive medications, followed by a routine stem cell transplant in order to assess whether or not it is as effective as myeloablative high dose chemotherapy and transplant.
Primary Outcome
Sustained stem cell engraftment of donor cells will be evaluated by chimerism (FISH fluorescence in situ hybridization OR VNTR (Variable Number of Tandem Repeats), based on recipient/donor gender, at 30 days, 100 days, 6 months and 1 year following the use of reduced intensity conditioning.
Interventions
- DRUG Fludarabine
- DRUG Melphalan
- DRUG Cyclosporine
- DRUG Mycophenolate mofetil
- DRUG alemtuzumab (Campath IH)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2008-12 |
| Est. Completion | 2019-12 |
| Phase | Phase 1 |
What the finished NCT02435901 record still lists
NCT02435901 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 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% lower).
The record links to 0 conditions, and to 5 interventions - of which Fludarabine is the first listed.
NCT02435901 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02435901 about?
NCT02435901 is a clinical study titled "HSCT For Patients With High Risk Hemoglobinopathies Using Reduced Intensity". This study will evaluate the use of reduced intensity conditioning regimen in patients with high risk hemoglobinopathy Sickle Cell and B-Thalassemia Major in combination with standard immunosuppressive medications, followed by a routine stem cell transplant in order to assess whether or not it is as...
What is the current status of trial NCT02435901?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 29 participants. The study started on 2008-12. Estimated completion is 2019-12.
What interventions are being tested in trial NCT02435901?
The interventions under investigation include: Fludarabine (DRUG), Melphalan (DRUG), Cyclosporine (DRUG), Mycophenolate mofetil (DRUG), alemtuzumab (Campath IH) (DRUG).
Who is sponsoring clinical trial NCT02435901?
This trial is sponsored by Northwell Health, which has 370 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02435901's enrollment target sits among peer trials
29 1440th of 2000 higher than 554 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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
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