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NCT00038415 · ClinicalTrials.gov registry record · Phase 1

A Phase I/II Trial of Idiotypic Vaccination for Chronic Lymphocytic Leukemia Using a Genetic Approach

A Phase 1 study, sponsored by M.D. Anderson Cancer Center.

Terminated
Registry status
Phase 1
Development phase
2
Enrollment target

NCT00038415: Clinical Trial Phase 1 study, sponsored by M.D. Anderson Cancer Center.

NCT00038415 is a Phase 1 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 2 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00038415, a Phase 1 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.

TERMINATED
Registry status
Phase 1
Development phase
2 participants
Enrollment target

Study Summary

The goal of this clinical research study is learn if a vaccine that contains the patient's own cancer cell immunoglobulin can shrink or slow the growth of Chronic Lymphocytic Leukemia (CLL). This clinical trial is a dose escalation study in which the safety of this vaccine will be studied. This is a dose escalation study in which each patient will receive vaccine at one dose level. Patients will be injected with a fragment of Deoxyribonucleic acid (DNA) containing the sequence of their own immunoglobulin gene. Patients will be required to have their diagnosis of CLL and stage confirmed prior to initiating vaccination. After vaccination patients will receive clinical and immunologic evaluation, including both humoral and cellular responses. The investigator will be assessing the patient's immune response or whether the patient's body recognizes the DNA vaccine. In addition, side effects and reactions to the vaccine will be evaluated.

Interventions

  • BIOLOGICAL CLL vaccine using DNA plasmid vector

Trial Details

FieldValue
Enrollment Target 2 participants
Start Date 2001-12
Est. Completion 2005-01
Phase Phase 1

Sponsor

M.D. Anderson Cancer Center

2,692 total trials

What the Registry Record Tells You About NCT00038415

The ClinicalTrials.gov registry entry for NCT00038415 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which CLL vaccine using DNA plasmid vector is the first listed.

NCT00038415 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00038415 about?

NCT00038415 is a clinical study titled "A Phase I/II Trial of Idiotypic Vaccination for Chronic Lymphocytic Leukemia Using a Genetic Approach". The goal of this clinical research study is learn if a vaccine that contains the patient's own cancer cell immunoglobulin can shrink or slow the growth of Chronic Lymphocytic Leukemia (CLL). This clinical trial is a dose escalation study in which the safety of this vaccine will be studied. This is a...

What is the current status of trial NCT00038415?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2001-12. Estimated completion is 2005-01.

What interventions are being tested in trial NCT00038415?

The interventions under investigation include: CLL vaccine using DNA plasmid vector (BIOLOGICAL).

Who is sponsoring clinical trial NCT00038415?

This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 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, the data changelog, or report a data error.