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NCT00582933 · ClinicalTrials.gov registry record · Phase 2
Phase II Trial of a Chemotherapy Alone Regimen of IV Busulfan (Busulfex), Melphalan and Fludarabine as Myeloablative Regimen Followed by an Allogeneic T-Cell Depleted Hematopoietic Stem Cell Transplant From an HLA-Identical, or HLA-Non Identical Related or Unrelated Donor
A Phase 2 study of Leukemia and Myelodysplastic Syndrome, sponsored by Memorial Sloan Kettering Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 96
- Enrollment target
- 1
- Study location
NCT00582933 is a Phase 2 study of Leukemia and Myelodysplastic Syndrome that has completed, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 96 participants, below the 486-participant average among 233 other Leukemia trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00582933, a Phase 2 study of Leukemia and Myelodysplastic Syndrome, has completed, sponsored by Memorial Sloan Kettering Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 96 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this research study is:(1) to determine if high doses of chemotherapy without total body irradiation can allow selected stem cells to take and grow,(2) to determine if selected stem cells from the blood or marrow can take and not cause a complication called graft-versus-host disease (GvHD) and (3) to evaluate the side effects of the combination of chemotherapy drugs used for these transplants. In the last 10 years we have developed chemotherapy combinations to be used for this T-cell depleted transplant protocol. By using three chemotherapy drugs (IV busulfan, melphalan and fludarabine), we hope to have a good chemotherapy combination to kill cancer cells, and to make the graft take, without the side effects of total body irradiation. The chemotherapy drugs to be tested in this protocol are busulfan, melphalan and fludarabine, all of which have been used successfully for stem cell transplantation, but not given together as in this specific regimen. This is what is being tested in this study. Our initial trials in the 1980's with T-cell depleted transplants showed less GvHD, but the overall results of the transplants were not better. The reason for this was that the stem cells did not take and engraft in 15% of our adult patients. This failure of the stem cells to take can leave patients without bone marrow or blood cells necessary for life. Most stem cell transplants were done using bone marrow (BMA) obtained from the donors. However, if we give a medication called G-CSF by shots to the donor, we can collect peripheral blood stem cells (PBSC) and use them for transplant. The advantage of this approach is that we can collect 2-20 times more stem cells than that obtained from the marrow. It has been proven that a larger number of stem cells in the graft make it more difficult for the patient to reject the stem cells. Some donors may be too small to provide peripheral blood stem cells or they may not want to take G-CSF shots. In these cases the donors w
Conditions Studied
Interventions
- DRUG BUSULFAN, MELPHALAN, FLUDARABINE, G-CSF
Study Locations (1)
New York
- Memorial Sloan-Kettering Cancer Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 96 participants |
| Start Date | 2001-05 |
| Est. Completion | 2009-04 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00582933
The ClinicalTrials.gov registry entry for NCT00582933 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 96 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 486-participant average among 233 other Leukemia trials with a reported enrollment target (80% lower). The listed sponsor is Memorial Sloan Kettering Cancer Center, which has 1,884 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Leukemia appearing as the primary indexed condition, and to 1 intervention - of which BUSULFAN, MELPHALAN, FLUDARABINE, G-CSF is the first listed.
NCT00582933 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT00582933 about?
NCT00582933 is a clinical study titled "Phase II Trial of a Chemotherapy Alone Regimen of IV Busulfan (Busulfex), Melphalan and Fludarabine as Myeloablative Regimen Followed by an Allogeneic T-Cell Depleted Hematopoietic Stem Cell Transplant From an HLA-Identical, or HLA-Non Identical Related or Unrelated Donor". The purpose of this research study is:(1) to determine if high doses of chemotherapy without total body irradiation can allow selected stem cells to take and grow,(2) to determine if selected stem cells from the blood or marrow can take and not cause a complication called graft-versus-host disease (...
What is the current status of trial NCT00582933?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 96 participants. The study started on 2001-05. Estimated completion is 2009-04.
What conditions does trial NCT00582933 study?
This clinical trial studies the following conditions: Leukemia, Myelodysplastic Syndrome, Non-Hodgkin's Lymphoma, Allogeneic Marrow Transplant.
What interventions are being tested in trial NCT00582933?
The interventions under investigation include: BUSULFAN, MELPHALAN, FLUDARABINE, G-CSF (DRUG).
Who is sponsoring clinical trial NCT00582933?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00582933 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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