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NCT00253513 · ClinicalTrials.gov registry record · Phase 1
Treosulfan and Fludarabine in Treating Younger Patients Who Are Undergoing a Donor Stem Cell Transplant for Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, or Myelodysplastic Syndrome
A Phase 1 study, sponsored by OHSU Knight Cancer Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
NCT00253513: Completed Phase 1 study, sponsored by OHSU Knight Cancer Institute.
NCT00253513 is a Phase 1 study that has completed, run by OHSU Knight Cancer Institute. The registered enrollment target is 60 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00253513, a Phase 1 study, has completed, sponsored by OHSU Knight Cancer Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
Study Summary
RATIONALE: Drugs used in chemotherapy, such as treosulfan and fludarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving treosulfan and fludarabine together with a donor bone marrow transplant or a peripheral stem cell transplant may be an effective treatment for acute myeloid leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome. PURPOSE: This phase II trial is studying giving treosulfan together with fludarabine to see how well it works in treating patients who are undergoing a donor stem cell transplant for acute myeloid leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome.
Primary Outcome
Proportion of patients experiencing regimen-related toxicity to major organ systems from day minus 6 to day 28. Major organ systems: cardiac, bladder/renal, pulmonary, hepatic, neurologic and gastrointestinal
Interventions
- DRUG fludarabine
- DRUG treosulfan
- PROCEDURE allogeneic blood or bone marrow transplantation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2005-06 |
| Est. Completion | 2009-10 |
| Phase | Phase 1 |
What the finished NCT00253513 record still lists
NCT00253513 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which fludarabine is the first listed.
NCT00253513 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00253513 about?
NCT00253513 is a clinical study titled "Treosulfan and Fludarabine in Treating Younger Patients Who Are Undergoing a Donor Stem Cell Transplant for Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, or Myelodysplastic Syndrome". RATIONALE: Drugs used in chemotherapy, such as treosulfan and fludarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving treosulfan and fludarabine together with a donor bone marrow transplant or a peripheral stem cel...
What is the current status of trial NCT00253513?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2005-06. Estimated completion is 2009-10.
What interventions are being tested in trial NCT00253513?
The interventions under investigation include: fludarabine (DRUG), treosulfan (DRUG), allogeneic blood or bone marrow transplantation (PROCEDURE).
Who is sponsoring clinical trial NCT00253513?
This trial is sponsored by OHSU Knight Cancer Institute, which has 211 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00253513's enrollment target sits among peer trials
60 831st of 2000 higher than 1,106 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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