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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 is a Phase 1 study that was terminated before completion, run by Baylor College of Medicine. The registered enrollment target is 4 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00579111
The ClinicalTrials.gov registry entry for NCT00579111 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Fludarabine is the first listed.
NCT00579111 reports 0 study locations.
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.
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