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

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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Number of patients alive and without disease progression or relapse

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 finished NCT00363649 record still lists

NCT00363649 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower).

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

NCT00363649 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00363649's enrollment target sits among peer trials

36 1496th of 2000 higher than 477 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00363649, the US trial registry maintained by the National Library of Medicine. NCT00363649 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.