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NCT00301093 · ClinicalTrials.gov registry record · Phase 1

Vaccine Therapy and Imatinib Mesylate in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia

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

Completed
Registry status
Phase 1
Development phase
3
Enrollment target
1
Study location

NCT00301093: Completed Phase 1 study of Leukemia, sponsored by Dana-Farber Cancer Institute.

NCT00301093 is a Phase 1 study of Leukemia that has completed, run by Dana-Farber Cancer Institute. The registered enrollment target is 3 participants, below the 487-participant average among 233 other Leukemia trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00301093, a Phase 1 study of Leukemia, has completed, sponsored by Dana-Farber Cancer Institute.

COMPLETED
Registry status
Phase 1
Development phase
3 participants
Enrollment target
1
Study location

Study Summary

RATIONALE: Vaccines made from gene-modified cancer cells may help the body build an effective immune response to kill cancer cells. Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving vaccine therapy together with imatinib mesylate may be an effective treatment for chronic myelogenous leukemia. PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy when given together with imatinib mesylate in treating patients with chronic phase chronic myelogenous leukemia.

Primary Outcome

To assess the safety and toxicity of GM-K462 vaccination in CP CML patients who have acheived a complete hematologic response to imatinib.

Conditions Studied

Interventions

  • DRUG imatinib mesylate
  • BIOLOGICAL GM-K562 cell vaccine

Study Locations (1)

Massachusetts

  • Dana Farber Cancer Institute - Boston

Trial Details

FieldValue
Enrollment Target 3 participants
Start Date 2005-09
Est. Completion 2020-09-10
Phase Phase 1
Dana-Farber Cancer Institute

781 total trials

What the finished NCT00301093 record still lists

NCT00301093 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 487-participant average among 233 other Leukemia trials with a reported enrollment target (99% lower).

The record links to 1 condition, with Leukemia appearing as the primary indexed condition, and to 2 interventions - of which imatinib mesylate is the first listed.

NCT00301093 reports a single indexed study location in Massachusetts.

Frequently Asked Questions

What is clinical trial NCT00301093 about?

NCT00301093 is a clinical study titled "Vaccine Therapy and Imatinib Mesylate in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia". RATIONALE: Vaccines made from gene-modified cancer cells may help the body build an effective immune response to kill cancer cells. Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving vaccine therapy together with imatinib mesylate may...

What is the current status of trial NCT00301093?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2005-09. Estimated completion is 2020-09-10.

What conditions does trial NCT00301093 study?

This clinical trial studies the following conditions: Leukemia.

What interventions are being tested in trial NCT00301093?

The interventions under investigation include: imatinib mesylate (DRUG), GM-K562 cell vaccine (BIOLOGICAL).

Who is sponsoring clinical trial NCT00301093?

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

Where is trial NCT00301093 being conducted?

This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Leukemia

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00301093's enrollment target sits among peer trials

3 230th of 233 higher than 3 of 233 other Leukemia trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Leukemia 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 NCT00301093, the US trial registry maintained by the National Library of Medicine. NCT00301093 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.