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NCT01991457 · ClinicalTrials.gov registry record · Phase 2
Fludarabine / Total Body Irradiation Regimen for ALLO HCT in Acute Lymphoblastic Leukemia
A Phase 2 study, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- Phase 2
- Development phase
- 19
- Enrollment target
NCT01991457: Completed Phase 2 study, sponsored by University of Alabama at Birmingham.
NCT01991457 is a Phase 2 study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 19 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01991457, a Phase 2 study, has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 19 participants
- Enrollment target
Study Summary
The goal of this research is to test if the conditioning regimen, fludarabine and total body irradiation (FluTBI), can lead to a safer and more effective stem cell transplant treatment regimen for ALL patients older than 40 years of age and/or younger patients with high risk medical conditions. The primary objective is to establish the efficacy of allo HCT in older ALL patients using myeloablative FluTBI conditioning regimen. The investigators are also assessing the safety and toxicity of allo HCT in older ALL patients using myeloablative FluTBI conditioning regimen.
Primary Outcome
Percentage of patients without relapse of disease at 2 years
Interventions
- DRUG Fludarabine
- PROCEDURE Total Body Irradiation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2013-08-27 |
| Est. Completion | 2022-08-23 |
| Phase | Phase 2 |
What the finished NCT01991457 record still lists
NCT01991457 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 2 interventions - of which Fludarabine is the first listed.
NCT01991457 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01991457 about?
NCT01991457 is a clinical study titled "Fludarabine / Total Body Irradiation Regimen for ALLO HCT in Acute Lymphoblastic Leukemia". The goal of this research is to test if the conditioning regimen, fludarabine and total body irradiation (FluTBI), can lead to a safer and more effective stem cell transplant treatment regimen for ALL patients older than 40 years of age and/or younger patients with high risk medical conditions. The ...
What is the current status of trial NCT01991457?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 19 participants. The study started on 2013-08-27. Estimated completion is 2022-08-23.
What interventions are being tested in trial NCT01991457?
The interventions under investigation include: Fludarabine (DRUG), Total Body Irradiation (PROCEDURE).
Who is sponsoring clinical trial NCT01991457?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01991457's enrollment target sits among peer trials
19 1894th of 2000 higher than 103 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
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