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NCT00809250 · ClinicalTrials.gov registry record · Phase 1

Vaccination With GM-K562 Cells in Patients With Advanced Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML) After Allogeneic Hematopoetic Stem Cell Transplantation

A Phase 1 study, sponsored by Dana-Farber Cancer Institute.

Completed
Registry status
Phase 1
Development phase
33
Enrollment target

NCT00809250 is a Phase 1 study that has completed, run by Dana-Farber Cancer Institute. The registered enrollment target is 33 participants.

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The verdict

NCT00809250, a Phase 1 study, has completed, sponsored by Dana-Farber Cancer Institute.

COMPLETED
Registry status
Phase 1
Development phase
33 participants
Enrollment target

Study Summary

The purpose of this research study is to determine if the GM-K562/leukemia cell vaccine can be safely given soon after allogeneic marrow or blood stem cell transplant. The GM-K562/leukemia cell vaccine is composed of a cultured cell line that has been genetically modified to secrete GM-CSF, a naturally occuring substance in the body that stimulates the immune system. The vaccine is a mixture of the GM-K562 cells (radiated to prevent them from growing in the participants body) with the participant's previously frozen and killed leukemia cells. By mixing the GM-K562 with the leukemia cells, we would like to study whether this vaccine combination will stimulate the participant's new immune system to recognize and fight against their MDS/AML cancer cells.

Interventions

  • BIOLOGICAL GM-K562/leukemia cell vaccine

Trial Details

FieldValue
Enrollment Target 33 participants
Start Date 2008-11
Est. Completion 2020-01
Phase Phase 1

Sponsor

Dana-Farber Cancer Institute

781 total trials

What the Registry Record Tells You About NCT00809250

The ClinicalTrials.gov registry entry for NCT00809250 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 33 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Dana-Farber Cancer Institute, which has 781 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which GM-K562/leukemia cell vaccine is the first listed.

NCT00809250 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00809250 about?

NCT00809250 is a clinical study titled "Vaccination With GM-K562 Cells in Patients With Advanced Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML) After Allogeneic Hematopoetic Stem Cell Transplantation". The purpose of this research study is to determine if the GM-K562/leukemia cell vaccine can be safely given soon after allogeneic marrow or blood stem cell transplant. The GM-K562/leukemia cell vaccine is composed of a cultured cell line that has been genetically modified to secrete GM-CSF, a natura...

What is the current status of trial NCT00809250?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 33 participants. The study started on 2008-11. Estimated completion is 2020-01.

What interventions are being tested in trial NCT00809250?

The interventions under investigation include: GM-K562/leukemia cell vaccine (BIOLOGICAL).

Who is sponsoring clinical trial NCT00809250?

This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.

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

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.