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NCT00488592 · ClinicalTrials.gov registry record · Phase 2
Peptide Vaccinations to Treat Patients With Low-Risk Myeloid Cancers
A Phase 2 study of Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS), sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Completed
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT00488592 is a Phase 2 study of Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 10 participants, below the 145-participant average among 29 other Acute Myeloid Leukemia (AML) trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00488592, a Phase 2 study of Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS), has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will test the safety and effectiveness of two vaccines on slowing disease progression, improving blood counts, reducing the need for transfusions of blood and platelets, or achieving remission in patients with myelodysplastic syndrome (MDS, also known as myelodysplasia), acute myeloid leukemia (AML) or chronic myeloid leukemia (CML). The vaccines consist of peptides (parts of proteins) found in MDS, AML and CML stem cells, combined with a substance called "MontanideTM". They are administered with granulocyte- macrophage colony- stimulating factor (GM-CSF). The Montanide and the GM-CSF help the immune system respond to the vaccines. People 18 years of age or older with MDS, AML or CML may be eligible for this study. Participants receive six injections of the vaccines, one dose every other week for a total of 10 weeks. The injections are given in the upper arm, upper leg, or abdomen. A separate injection of GM-CSF is given in the same area as the vaccine injections. Subjects are observed for 2 hours after the first vaccination and at least 30 minutes after each subsequent vaccination for allergic reactions. In addition to the vaccination, subjects undergo the following: * History and physical exam, chest x-ray, blood tests and bone marrow aspirate and biopsy before starting the vaccinations. * Safety monitoring during vaccine administration (every other week for 10 weeks) with blood tests and check of vital signs. * Follow-up safety monitoring (weeks 12 and 16) with blood tests every visit, chest x-ray at week 12 and bone marrow biopsy visit 16.
Conditions Studied
Interventions
- DRUG GM-CSF (Sargramostim)
- BIOLOGICAL WT1:126-134
- BIOLOGICAL PR1:169-177 Peptide
- BIOLOGICAL Montanide adjuvant
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2007-06 |
| Est. Completion | 2010-04 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00488592
The ClinicalTrials.gov registry entry for NCT00488592 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 145-participant average among 29 other Acute Myeloid Leukemia (AML) trials with a reported enrollment target (93% lower). The listed sponsor is National Heart, Lung, and Blood Institute (NHLBI), which has 501 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Acute Myeloid Leukemia (AML) appearing as the primary indexed condition, and to 4 interventions - of which GM-CSF (Sargramostim) is the first listed.
NCT00488592 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00488592 about?
NCT00488592 is a clinical study titled "Peptide Vaccinations to Treat Patients With Low-Risk Myeloid Cancers". This study will test the safety and effectiveness of two vaccines on slowing disease progression, improving blood counts, reducing the need for transfusions of blood and platelets, or achieving remission in patients with myelodysplastic syndrome (MDS, also known as myelodysplasia), acute myeloid leu...
What is the current status of trial NCT00488592?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2007-06. Estimated completion is 2010-04.
What conditions does trial NCT00488592 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS), Chronic Myeloid Leukemia (CML).
What interventions are being tested in trial NCT00488592?
The interventions under investigation include: GM-CSF (Sargramostim) (DRUG), WT1:126-134 (BIOLOGICAL), PR1:169-177 Peptide (BIOLOGICAL), Montanide adjuvant (BIOLOGICAL).
Who is sponsoring clinical trial NCT00488592?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00488592 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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