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NCT00988715 · ClinicalTrials.gov registry record · Phase 1

Donor Peripheral Blood Stem Cell Transplant and Pretargeted Radioimmunotherapy in Treating Patients With High-Risk Advanced Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, or Myelodysplastic Syndrome

A Phase 1 study, sponsored by Fred Hutchinson Cancer Center.

Completed
Registry status
Phase 1
Development phase
17
Enrollment target

NCT00988715 is a Phase 1 study that has completed, run by Fred Hutchinson Cancer Center. The registered enrollment target is 17 participants.

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The verdict

NCT00988715, a Phase 1 study, has completed, sponsored by Fred Hutchinson Cancer Center.

COMPLETED
Registry status
Phase 1
Development phase
17 participants
Enrollment target

Study Summary

This phase I trial studies pretargeted radioimmunotherapy and donor peripheral blood stem cell transplant employing fludarabine phosphate and total-body irradiation (TBI) to treat patients with high-risk acute myeloid leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome. Giving chemotherapy drugs, such as fludarabine phosphate, and TBI before a donor peripheral blood stem cell transplant helps stop the patient's immune system from rejecting the donor's stem cells. Radiolabeled monoclonal antibodies can be combined with fludarabine phosphate and TBI to find cancer cells and kill them without harming normal cells. Pretargeted radioimmunotherapy (PRIT) allows for further improved targeting of tumor cells over standard directly labeled antibodies.

Interventions

  • RADIATION Total-Body Irradiation
  • DRUG Mycophenolate Mofetil
  • DRUG Cyclosporine
  • PROCEDURE Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation
  • BIOLOGICAL Pretargeted Radioimmunotherapy

Trial Details

FieldValue
Enrollment Target 17 participants
Start Date 2010-04-21
Phase Phase 1

Sponsor

Fred Hutchinson Cancer Center

483 total trials

What the Registry Record Tells You About NCT00988715

The ClinicalTrials.gov registry entry for NCT00988715 describes a study currently listed as completed, categorized as Phase 1. 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 Total-Body Irradiation is the first listed.

NCT00988715 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00988715 about?

NCT00988715 is a clinical study titled "Donor Peripheral Blood Stem Cell Transplant and Pretargeted Radioimmunotherapy in Treating Patients With High-Risk Advanced Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, or Myelodysplastic Syndrome". This phase I trial studies pretargeted radioimmunotherapy and donor peripheral blood stem cell transplant employing fludarabine phosphate and total-body irradiation (TBI) to treat patients with high-risk acute myeloid leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome. Giving chemot...

What is the current status of trial NCT00988715?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2010-04-21.

What interventions are being tested in trial NCT00988715?

The interventions under investigation include: Total-Body Irradiation (RADIATION), Mycophenolate Mofetil (DRUG), Cyclosporine (DRUG), Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation (PROCEDURE), Pretargeted Radioimmunotherapy (BIOLOGICAL).

Who is sponsoring clinical trial NCT00988715?

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.