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NCT00008151 · ClinicalTrials.gov registry record · Phase 2

Gemtuzumab Ozogamicin, Fludarabine, and Total-body Irradiation Followed by Peripheral Stem Cell or Bone Marrow Transplantation in Treating Patients With Advanced Acute Myeloid Leukemia or Myelodysplastic Syndrome

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

Completed
Registry status
Phase 2
Development phase

NCT00008151: Completed Phase 2 study, sponsored by Fred Hutchinson Cancer Center.

NCT00008151 is a Phase 2 study that has completed, run by Fred Hutchinson Cancer Center. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00008151, a Phase 2 study, has completed, sponsored by Fred Hutchinson Cancer Center.

COMPLETED
Registry status
Phase 2
Development phase

Study Summary

RATIONALE: Monoclonal antibodies such as gemtuzumab ozogamicin can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Peripheral stem cell or bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy and radiation therapy used to kill cancer cells. PURPOSE: Phase II trial to study the effectiveness of gemtuzumab ozogamicin combined with fludarabine and total-body irradiation followed by donor peripheral stem cell or bone marrow transplantation in treating patients who have advanced acute myeloid leukemia or myelodysplastic syndrome.

Interventions

  • DRUG fludarabine phosphate
  • DRUG methotrexate
  • DRUG cyclosporine
  • DRUG mycophenolate mofetil
  • DRUG gemtuzumab ozogamicin

Trial Details

FieldValue
Start Date 2000-10
Est. Completion 2002-07
Phase Phase 2
Fred Hutchinson Cancer Center

483 total trials

What the finished NCT00008151 record still lists

NCT00008151 is an interventional study that assigns participants to a tested intervention. An enrollment target was not published in the registry record, which is common for early-stage or observational entries.

The record links to 0 conditions, and to 5 interventions - of which fludarabine phosphate is the first listed.

NCT00008151 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00008151 about?

NCT00008151 is a clinical study titled "Gemtuzumab Ozogamicin, Fludarabine, and Total-body Irradiation Followed by Peripheral Stem Cell or Bone Marrow Transplantation in Treating Patients With Advanced Acute Myeloid Leukemia or Myelodysplastic Syndrome". RATIONALE: Monoclonal antibodies such as gemtuzumab ozogamicin can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Peripheral stem cell or bone marrow transplantation may be able to replace immune cells that were destroyed by chemot...

What is the current status of trial NCT00008151?

This trial is currently completed. It is a Phase 2 study. The study started on 2000-10. Estimated completion is 2002-07.

What interventions are being tested in trial NCT00008151?

The interventions under investigation include: fludarabine phosphate (DRUG), methotrexate (DRUG), cyclosporine (DRUG), mycophenolate mofetil (DRUG), gemtuzumab ozogamicin (DRUG).

Who is sponsoring clinical trial NCT00008151?

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

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Source: ClinicalTrials.gov NCT00008151, the US trial registry maintained by the National Library of Medicine. NCT00008151 (unsized enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.