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NCT01455506 · ClinicalTrials.gov registry record · Phase 1
PRO#0118: Decitabine Plus Mini Flu-Bu
A Phase 1 study, sponsored by Hackensack Meridian Health.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT01455506: Completed Phase 1 study, sponsored by Hackensack Meridian Health.
NCT01455506 is a Phase 1 study that has completed, run by Hackensack Meridian Health. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01455506, a Phase 1 study, has completed, sponsored by Hackensack Meridian Health.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
This is a single institution study of combining decitabine with fludarabine and busulfan in the setting of allogeneic stem cell transplantation. A study population of 20 subjects will be enrolled from The John Theurer Cancer Center at Hackensack University Medical Center. Subjects who are eligible to receive allogeneic hematopoietic stem cell transplantation according to the eligibility criteria will be consented and enrolled. Subjects will receive treatment with decitabine followed by reduced intensity fludarabine and busulfan prior to allogeneic stem cell transplantation. Subjects will be followed until 1 year post transplantation to assess stability of engraftment, toxicity, progression free survival, and disease response
Primary Outcome
Graft failure defined by the presence of \<10% donor lymphoid cells on peripheral blood analysis performed on post transplant day 84(+/- 10 days) in patients who have not relapsed will be measured.
Interventions
- DRUG Decitabine plus Fludarabine and Busulfan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2009-05 |
| Est. Completion | 2013-12 |
| Phase | Phase 1 |
What the finished NCT01455506 record still lists
NCT01455506 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 1 intervention - of which Decitabine plus Fludarabine and Busulfan is the first listed.
NCT01455506 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01455506 about?
NCT01455506 is a clinical study titled "PRO#0118: Decitabine Plus Mini Flu-Bu". This is a single institution study of combining decitabine with fludarabine and busulfan in the setting of allogeneic stem cell transplantation. A study population of 20 subjects will be enrolled from The John Theurer Cancer Center at Hackensack University Medical Center. Subjects who are eligible t...
What is the current status of trial NCT01455506?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2009-05. Estimated completion is 2013-12.
What interventions are being tested in trial NCT01455506?
The interventions under investigation include: Decitabine plus Fludarabine and Busulfan (DRUG).
Who is sponsoring clinical trial NCT01455506?
This trial is sponsored by Hackensack Meridian Health, which has 90 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01455506's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 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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