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NCT00119366 · ClinicalTrials.gov registry record · Phase 2
Iodine I 131 Monoclonal Antibody BC8, Fludarabine Phosphate, Total Body Irradiation, and Donor Stem Cell Transplant Followed by Cyclosporine and Mycophenolate Mofetil in Treating Patients With Advanced Acute Myeloid Leukemia or Myelodysplastic Syndrome
A Phase 2 study, sponsored by Fred Hutchinson Cancer Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 18
- Enrollment target
NCT00119366 is a Phase 2 study that was terminated before completion, run by Fred Hutchinson Cancer Center. The registered enrollment target is 18 participants.
The verdict
NCT00119366, a Phase 2 study, was terminated before completion, sponsored by Fred Hutchinson Cancer Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 18 participants
- Enrollment target
Study Summary
This phase II trial studies the side effects and best dose of iodine I 131 monoclonal antibody BC8 when given together with fludarabine phosphate, total-body irradiation, and donor stem cell transplant followed by cyclosporine and mycophenolate mofetil in treating patients with acute myeloid leukemia or myelodysplastic syndrome that has spread to other places in the body and usually cannot be cured or controlled with treatment. Giving chemotherapy drugs, such as fludarabine phosphate, and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cancer or abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. Also, radiolabeled monoclonal antibodies, such as iodine I 131 monoclonal antibody BC8, can find cancer cells and carry cancer-killing substances to them without harming normal cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving fludarabine phosphate and total-body irradiation before the transplant together with cyclosporine and mycophenolate mofetil after the transplant may stop this from happening. Giving a radiolabeled monoclonal antibody together with donor stem cell transplant, cyclosporine, and mycophenolate mofetil may be an effective treatment for advanced acute myeloid leukemia or myelodysplastic syndromes.
Interventions
- DRUG fludarabine phosphate
- PROCEDURE allogeneic hematopoietic stem cell transplantation
- PROCEDURE peripheral blood stem cell transplantation
- RADIATION total-body irradiation
- RADIATION iodine I 131 monoclonal antibody BC8
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2003-05 |
| Est. Completion | 2019-05-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00119366
The ClinicalTrials.gov registry entry for NCT00119366 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Fred Hutchinson Cancer Center, which has 483 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which fludarabine phosphate is the first listed.
NCT00119366 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00119366 about?
NCT00119366 is a clinical study titled "Iodine I 131 Monoclonal Antibody BC8, Fludarabine Phosphate, Total Body Irradiation, and Donor Stem Cell Transplant Followed by Cyclosporine and Mycophenolate Mofetil in Treating Patients With Advanced Acute Myeloid Leukemia or Myelodysplastic Syndrome". This phase II trial studies the side effects and best dose of iodine I 131 monoclonal antibody BC8 when given together with fludarabine phosphate, total-body irradiation, and donor stem cell transplant followed by cyclosporine and mycophenolate mofetil in treating patients with acute myeloid leukemi...
What is the current status of trial NCT00119366?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 18 participants. The study started on 2003-05. Estimated completion is 2019-05-08.
What interventions are being tested in trial NCT00119366?
The interventions under investigation include: fludarabine phosphate (DRUG), allogeneic hematopoietic stem cell transplantation (PROCEDURE), peripheral blood stem cell transplantation (PROCEDURE), total-body irradiation (RADIATION), iodine I 131 monoclonal antibody BC8 (RADIATION).
Who is sponsoring clinical trial NCT00119366?
This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.
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