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NCT01366612 · ClinicalTrials.gov registry record · Phase 3
Fludarabine and Busulfan vs. Fludarabine, Busulfan and Total Body Irradiation
A Phase 3 study, sponsored by Hackensack Meridian Health.
- Terminated
- Registry status
- Phase 3
- Development phase
- 53
- Enrollment target
NCT01366612: Clinical Trial Phase 3 study, sponsored by Hackensack Meridian Health.
NCT01366612 is a Phase 3 study that was terminated before completion, run by Hackensack Meridian Health. The registered enrollment target is 53 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01366612, a Phase 3 study, was terminated before completion, sponsored by Hackensack Meridian Health.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 53 participants
- Enrollment target
Study Summary
This is a single institution study of fludarabine and busulfan versus fludarabine, busulfan and low dose total body irradiation in patients undergoing allogeneic stem cell transplantation. A study population of 80 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 be randomly assigned to receive one of 2 conditioning regimen: fludarabine and busulfan, or fludarabine busulfan and low dose total body irradiation (TBI). Subjects will be followed until 1 year post transplantation to assess the relapse rate in each arm and transplant-related toxicity. The combination of fludarabine and busulfan is the current standard of care for patients with myeloid malignancies (AML, CML and other myeloproliferative disorders, or MDS) undergoing allogeneic transplantation at HUMC. In this study we will be comparing in a randomized fashion the standard regimen to a regimen of fludarabine, busulfan and TBI.
Interventions
- DRUG Fludarabine and Busulfan plus/minus Total Body Irradiation (low dose)
- DRUG Fludarabine and Busulfan + Low Dose Total Body Irradiation (LD TBI)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2010-06-16 |
| Est. Completion | 2020-08-18 |
| Phase | Phase 3 |
Why NCT01366612 stopped before completion
NCT01366612 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 2 interventions - of which Fludarabine and Busulfan plus/minus Total Body Irradiation (low dose) is the first listed.
NCT01366612 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01366612 about?
NCT01366612 is a clinical study titled "Fludarabine and Busulfan vs. Fludarabine, Busulfan and Total Body Irradiation". This is a single institution study of fludarabine and busulfan versus fludarabine, busulfan and low dose total body irradiation in patients undergoing allogeneic stem cell transplantation. A study population of 80 subjects will be enrolled from The John Theurer Cancer Center at Hackensack University...
What is the current status of trial NCT01366612?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 53 participants. The study started on 2010-06-16. Estimated completion is 2020-08-18.
What interventions are being tested in trial NCT01366612?
The interventions under investigation include: Fludarabine and Busulfan plus/minus Total Body Irradiation (low dose) (DRUG), Fludarabine and Busulfan + Low Dose Total Body Irradiation (LD TBI) (DRUG).
Who is sponsoring clinical trial NCT01366612?
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 NCT01366612's enrollment target sits among peer trials
53 1839th of 2000 higher than 160 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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