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NCT00579111 · ClinicalTrials.gov registry record · Phase 1
Reduced Intensity Preparative Regimen Followed by Stem Cell Transplant (FAB)
A Phase 1 study, sponsored by Baylor College of Medicine.
- Terminated
- Registry status
- Phase 1
- Development phase
- 4
- Enrollment target
NCT00579111: Clinical Trial Phase 1 study, sponsored by Baylor College of Medicine.
NCT00579111 is a Phase 1 study that was terminated before completion, run by Baylor College of Medicine. The registered enrollment target is 4 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00579111, a Phase 1 study, was terminated before completion, sponsored by Baylor College of Medicine.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 4 participants
- Enrollment target
Study Summary
Blood disorders such as leukemia or lymphoma or hemoglobinopathies can benefit from receiving an allogeneic (meaning that the cells are from a donor) stem cell transplant. Stem cells are created in the bone marrow. They grow into different types of blood cells that the body needs, including red blood cells, white blood cells, and platelets. In a transplant, the body's stem cells would be killed and then replaced by stem cells from the donor. Usually, patients are given very high doses of chemotherapy (drugs which kill cancer cells) prior to receiving a stem cell transplant. However, patients that are older, have received several prior treatments, or have other organ diseases are at a high risk of getting life-threatening treatment-related side effects from high doses of chemotherapy. Over the past several years, some doctors have begun to use lower doses of chemotherapy for preparing patients for a stem cell transplant. A condition that can occur after a stem cell transplant from a donor is Graft Versus Host Disease (GVHD). It is a rare but serious disorder that can strike persons whose immune system is suppressed and have received either a blood transfusion or a bone marrow transplant. Symptoms may include skin rash, intestinal problems similar to inflammation of the bowel and liver dysfunction. This research study uses a combination of lower-dose chemotherapy agents that is slightly different from those that have been used before. The medicines that will be used in this study are Fludarabine, Busulfan, both chemotherapy medicines, and Campath. Campath is a monoclonal antibody (a type of substance produced in the laboratory that binds to cancer cells). It helps the immune system see the cancer cell as something that needs to be destroyed. This research study will help us learn if using Fludarabine, Busulfan and Campath prior to an allogeneic stem cell transplant can provide treatment for blood disorders while decreasing the incidence of side effects.
Primary Outcome
Each patient will be classified as a success or failure. A success will be defined as engraftment of at least 35% of cells 100 days after transplant.
Interventions
- DRUG Fludarabine
- DRUG Busulfan
- DRUG Campath
- DRUG FK-506
- PROCEDURE Hematopoietic stem cell infusion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2007-06 |
| Est. Completion | 2010-10 |
| Phase | Phase 1 |
Why NCT00579111 stopped before completion
NCT00579111 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 5 interventions - of which Fludarabine is the first listed.
NCT00579111 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00579111 about?
NCT00579111 is a clinical study titled "Reduced Intensity Preparative Regimen Followed by Stem Cell Transplant (FAB)". Blood disorders such as leukemia or lymphoma or hemoglobinopathies can benefit from receiving an allogeneic (meaning that the cells are from a donor) stem cell transplant. Stem cells are created in the bone marrow. They grow into different types of blood cells that the body needs, including red bloo...
What is the current status of trial NCT00579111?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 4 participants. The study started on 2007-06. Estimated completion is 2010-10.
What interventions are being tested in trial NCT00579111?
The interventions under investigation include: Fludarabine (DRUG), Busulfan (DRUG), Campath (DRUG), FK-506 (DRUG), Hematopoietic stem cell infusion (PROCEDURE).
Who is sponsoring clinical trial NCT00579111?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00579111's enrollment target sits among peer trials
4 1995th of 2000 higher than 2 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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