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NCT00973804 · ClinicalTrials.gov registry record · Phase 1
Pilot Trial of Targeted Immune-Depleting Chemotherapy and Reduced-Intensity Matched Unrelated Double Cord Blood Transplant for the Treatment of Leukemias, Lymphomas, and Pre-Malignant Blood Disorders
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 1
- Development phase
- 4
- Enrollment target
NCT00973804: Clinical Trial Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT00973804 is a Phase 1 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 4 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00973804, a Phase 1 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 4 participants
- Enrollment target
Study Summary
Background: * Allogeneic stem cell transplantation (SCT) has been used to treat many kinds of cancer or pre-cancerous conditions that develop in blood or immune system cells. Umbilical cord blood transplantation (UCBT) is a type of allogeneic transplant that is used when none of a patient s siblings are a match and an acceptable match cannot be identified from one of the bone marrow registries. Prior to receiving the cord blood stem cells, large doses of chemotherapy drugs and/or radiation have been traditionally used to eliminate most of the cancerous or abnormal cells from the recipient s system, along with most of his or her own stem cells and immune cells. Donor stem cells then replace the recipient s stem cells in the bone marrow, restoring normal blood production and immunity. In this way, an allogeneic SCT provides not only new blood cells but an entire new immune system. * In the past, allogeneic SCT was performed with very high doses of chemotherapy and/or radiation to get rid of as much of the recipient s cancer as possible and prevent rejection of the treatment. However, intensive chemotherapy or radiation can cause serious side effects, including death. A newer method uses smaller, less toxic doses of chemotherapy and/or radiation before allogeneic SCT. In these reduced-intensity stem cell transplants, the recipient s stem cells and immunity are not completely eliminated, but they are weakened enough to help prevent the donor s cells from being rejected. Objectives: \- To study the safety and effectiveness of reduced-intensity stem cell transplants given with immune-depleting chemotherapy and umbilical cord blood provided by an unrelated donor. Eligibility: * Individuals between 18 and 69 years of age who have been diagnosed with any of a number of cancerous and pre-cancerous blood conditions, including lymphoma and leukemia. * Participants must not have a potential donor sibling or a readily available unrelated donor identified through one of the b
Interventions
- DRUG FLAG
- DRUG EPOCH-F/R
- DRUG Transplant Preparative Regimen (Flu/Cy/Mes)
- DRUG GVHD Prophylaxis (tacrolimus and sirolimus)
- PROCEDURE Double Cord Blood Transplantation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2009-08-25 |
| Est. Completion | 2013-05-20 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00973804
The ClinicalTrials.gov registry entry for NCT00973804 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 National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which FLAG is the first listed.
NCT00973804 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00973804 about?
NCT00973804 is a clinical study titled "Pilot Trial of Targeted Immune-Depleting Chemotherapy and Reduced-Intensity Matched Unrelated Double Cord Blood Transplant for the Treatment of Leukemias, Lymphomas, and Pre-Malignant Blood Disorders". Background: * Allogeneic stem cell transplantation (SCT) has been used to treat many kinds of cancer or pre-cancerous conditions that develop in blood or immune system cells. Umbilical cord blood transplantation (UCBT) is a type of allogeneic transplant that is used when none of a patient s sibling...
What is the current status of trial NCT00973804?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 4 participants. The study started on 2009-08-25. Estimated completion is 2013-05-20.
What interventions are being tested in trial NCT00973804?
The interventions under investigation include: FLAG (DRUG), EPOCH-F/R (DRUG), Transplant Preparative Regimen (Flu/Cy/Mes) (DRUG), GVHD Prophylaxis (tacrolimus and sirolimus) (DRUG), Double Cord Blood Transplantation (PROCEDURE).
Who is sponsoring clinical trial NCT00973804?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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