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NCT00363649 · ClinicalTrials.gov registry record · Phase 2

Interferon and GM-CSF Compared With Imatinib Mesylate and Vaccine Therapy in Patients With Chronic Phase CML on a TKI

A Phase 2 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

Completed
Registry status
Phase 2
Development phase
36
Enrollment target

NCT00363649 is a Phase 2 study that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 36 participants.

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The verdict

NCT00363649, a Phase 2 study, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

COMPLETED
Registry status
Phase 2
Development phase
36 participants
Enrollment target

Study Summary

RATIONALE: Tyrosine kinase inhibitors may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Interferon alfa may interfere with the growth of cancer cells. GM-CSF may help cells that are involved in the body's immune response work better. Vaccines made from a person's cancer cells may help the body build an effective immune response to kill cancer cells. PURPOSE: This randomized phase II trial is studying tyrosine kinase inhibitors, interferon alfa, and GM-CSF to see how well they work compared to tyrosine kinase inhibitors and vaccine therapy in treating patients with chronic phase chronic myelogenous leukemia.

Interventions

  • BIOLOGICAL Sargramostim
  • BIOLOGICAL GM-K562 cell vaccine
  • BIOLOGICAL Interferon alfa

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2006-09
Est. Completion 2017-09
Phase Phase 2

What the Registry Record Tells You About NCT00363649

The ClinicalTrials.gov registry entry for NCT00363649 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which Sargramostim is the first listed.

NCT00363649 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00363649 about?

NCT00363649 is a clinical study titled "Interferon and GM-CSF Compared With Imatinib Mesylate and Vaccine Therapy in Patients With Chronic Phase CML on a TKI". RATIONALE: Tyrosine kinase inhibitors may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Interferon alfa may interfere with the growth of cancer cells. GM-CSF may help cells that are involved in the body's immune response work better. Vaccines made from a per...

What is the current status of trial NCT00363649?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2006-09. Estimated completion is 2017-09.

What interventions are being tested in trial NCT00363649?

The interventions under investigation include: Sargramostim (BIOLOGICAL), GM-K562 cell vaccine (BIOLOGICAL), Interferon alfa (BIOLOGICAL).

Who is sponsoring clinical trial NCT00363649?

This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 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.