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NCT00045435 · ClinicalTrials.gov registry record · Phase 2

Reduced Intensity Donor Peripheral Blood Stem Cell Transplant in Treating Patients With De Novo or Secondary Acute Myeloid Leukemia in Remission

A Phase 2 study, sponsored by Fred Hutchinson Cancer Center.

Completed
Registry status
Phase 2
Development phase
17
Enrollment target

NCT00045435 is a Phase 2 study that has completed, run by Fred Hutchinson Cancer Center. The registered enrollment target is 17 participants.

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The verdict

NCT00045435, a Phase 2 study, has completed, sponsored by Fred Hutchinson Cancer Center.

COMPLETED
Registry status
Phase 2
Development phase
17 participants
Enrollment target

Study Summary

This phase II trial studies how well reduced intensity donor peripheral blood stem cell (PBSC) transplant works in treating patients with de novo or secondary acute myeloid leukemia (AML) in remission. Giving low doses of chemotherapy, such as fludarabine phosphate, and total-body irradiation (TBI) before a donor PBSC transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil after the transplant may stop this from happening

Interventions

  • DRUG fludarabine phosphate
  • DRUG cyclosporine
  • RADIATION total-body irradiation
  • DRUG mycophenolate mofetil
  • PROCEDURE nonmyeloablative allogeneic hematopoietic stem cell transplantation

Trial Details

FieldValue
Enrollment Target 17 participants
Start Date 2002-04
Est. Completion 2009-01
Phase Phase 2

Sponsor

Fred Hutchinson Cancer Center

483 total trials

What the Registry Record Tells You About NCT00045435

The ClinicalTrials.gov registry entry for NCT00045435 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 17 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.

NCT00045435 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00045435 about?

NCT00045435 is a clinical study titled "Reduced Intensity Donor Peripheral Blood Stem Cell Transplant in Treating Patients With De Novo or Secondary Acute Myeloid Leukemia in Remission". This phase II trial studies how well reduced intensity donor peripheral blood stem cell (PBSC) transplant works in treating patients with de novo or secondary acute myeloid leukemia (AML) in remission. Giving low doses of chemotherapy, such as fludarabine phosphate, and total-body irradiation (TBI) ...

What is the current status of trial NCT00045435?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 17 participants. The study started on 2002-04. Estimated completion is 2009-01.

What interventions are being tested in trial NCT00045435?

The interventions under investigation include: fludarabine phosphate (DRUG), cyclosporine (DRUG), total-body irradiation (RADIATION), mycophenolate mofetil (DRUG), nonmyeloablative allogeneic hematopoietic stem cell transplantation (PROCEDURE).

Who is sponsoring clinical trial NCT00045435?

This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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