Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01471444 · ClinicalTrials.gov registry record · Phase 3
Fludarabine-IV Busulfan ± Clofarabine and Allogeneic Hematopoietic Stem Cell Transplantation for Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS)
A Phase 3 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 3
- Development phase
- 256
- Enrollment target
NCT01471444: Completed Phase 3 study, sponsored by M.D. Anderson Cancer Center.
NCT01471444 is a Phase 3 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 256 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01471444, a Phase 3 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 256 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to learn if combining busulfan with clofarabine and fludarabine can help control the disease better than the previous standard method (using busulfan and fludarabine alone) in patients with AML or MDS. The safety of this combination therapy will also be studied.
Primary Outcome
Number of events with progression free survival. (Progression is defined as more than 5% blast in the peripheral blood or bone marrow biopsy.) or expired from treatment related mortality post transplant.
Interventions
- DRUG Fludarabine
- DRUG Busulfan
- DRUG Thymoglobulin
- DRUG Clofarabine
- PROCEDURE Stem Cell Infusion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 256 participants |
| Start Date | 2011-11-02 |
| Est. Completion | 2020-12-14 |
| Phase | Phase 3 |
What the finished NCT01471444 record still lists
NCT01471444 is an interventional study that assigns participants to a tested intervention. The registered 256 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 5 interventions - of which Fludarabine is the first listed.
NCT01471444 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01471444 about?
NCT01471444 is a clinical study titled "Fludarabine-IV Busulfan ± Clofarabine and Allogeneic Hematopoietic Stem Cell Transplantation for Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS)". The goal of this clinical research study is to learn if combining busulfan with clofarabine and fludarabine can help control the disease better than the previous standard method (using busulfan and fludarabine alone) in patients with AML or MDS. The safety of this combination therapy will also be st...
What is the current status of trial NCT01471444?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 256 participants. The study started on 2011-11-02. Estimated completion is 2020-12-14.
What interventions are being tested in trial NCT01471444?
The interventions under investigation include: Fludarabine (DRUG), Busulfan (DRUG), Thymoglobulin (DRUG), Clofarabine (DRUG), Stem Cell Infusion (PROCEDURE).
Who is sponsoring clinical trial NCT01471444?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01471444's enrollment target sits among peer trials
256 1240th of 2000 higher than 759 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
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
- NCT02464696 · 256 participants · NA
Non-invasive Ventilation in Reducing the Need for Intubation in Patients With Cancer and Respiratory Failure
- NCT03793062 · 256 participants
Genetic and Epigenetic Basis of Chronic Wounds
- NCT04322318 · 256 participants · Phase 2
A Study of Combination Chemotherapy for Patients With Newly Diagnosed DAWT and Relapsed FHWT
- NCT04468360 · 256 participants · Phase 2
Facilitation of Extinction Retention and Reconsolidation Blockade in PTSD
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI