Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00943319 · ClinicalTrials.gov registry record · Phase 1
Busulfan-fludarabine Conditioning and T-cell Depleted Allogeneic Stem Cell Transplantation for Patients With Advanced Hematologic Malignancies
A Phase 1 study, sponsored by University of Chicago.
- Completed
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
NCT00943319: Completed Phase 1 study, sponsored by University of Chicago.
NCT00943319 is a Phase 1 study that has completed, run by University of Chicago. The registered enrollment target is 50 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00943319, a Phase 1 study, has completed, sponsored by University of Chicago.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
Study Summary
The purpose of this study is: 1. To establish the maximally tolerated dose (MTD) of intravenous busulfan (Busulfan®) in combination with fludarabine as conditioning regimen for transplantation with in-vivo T-cell depletion. 2. To evaluate disease free and overall survival after this conditioning regimen in patients with advanced acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). 3. To evaluate potential pharmacogenomic determinants of toxicity of this regimen. 4. To evaluate potential pharmacogenomic determinants of efficacy of this regimen.
Primary Outcome
Maximally tolerated area under the curve of intravenous busulfan (Busulfan®) in combination with fludarabine as conditioning regimen for transplantation with in-vivo T-cell depletion. The number reported will be an Area Under the Curve (AUC) measure reported in µmol-min/L.
Interventions
- DRUG Fludarabine
- DRUG Busulfan
- DRUG Campath
- PROCEDURE Stem Cell Transplant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2012-03 |
| Est. Completion | 2018-12 |
| Phase | Phase 1 |
What the finished NCT00943319 record still lists
NCT00943319 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower).
The record links to 0 conditions, and to 4 interventions - of which Fludarabine is the first listed.
NCT00943319 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00943319 about?
NCT00943319 is a clinical study titled "Busulfan-fludarabine Conditioning and T-cell Depleted Allogeneic Stem Cell Transplantation for Patients With Advanced Hematologic Malignancies". The purpose of this study is: 1. To establish the maximally tolerated dose (MTD) of intravenous busulfan (Busulfan®) in combination with fludarabine as conditioning regimen for transplantation with in-vivo T-cell depletion. 2. To evaluate disease free and overall survival after this conditioning re...
What is the current status of trial NCT00943319?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2012-03. Estimated completion is 2018-12.
What interventions are being tested in trial NCT00943319?
The interventions under investigation include: Fludarabine (DRUG), Busulfan (DRUG), Campath (DRUG), Stem Cell Transplant (PROCEDURE).
Who is sponsoring clinical trial NCT00943319?
This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00943319's enrollment target sits among peer trials
50 973rd of 2000 higher than 984 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
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
- NCT00200889 · 50 participants · Early Phase 1
Mapping Auricular Vagus Nerve Circuitry
- NCT00409435 · 50 participants · Phase 2
A Study of Pyridostigmine in Postural Tachycardia Syndrome
- NCT01202305 · 50 participants
The Use of Lymph Node Biopsies to Support HIV Pathogenesis Studies
- NCT01225913 · 50 participants · Phase 4
Mechanism(s) of Airflow Limitation During Exacerbation of Asthma
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