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NCT00433745 · ClinicalTrials.gov registry record · Phase 2
Wilm's Tumor 1 (WT1) Peptide Vaccine for High Risk Hematologic Malignancy
A Phase 2 study of Myelodysplastic Syndrome and Acute Myeloid Leukemia (AML), sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Completed
- Registry status
- Phase 2
- Development phase
- 4
- Enrollment target
- 1
- Study location
NCT00433745 is a Phase 2 study of Myelodysplastic Syndrome and Acute Myeloid Leukemia (AML) that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 4 participants, below the 207-participant average among 134 other Myelodysplastic Syndrome trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00433745, a Phase 2 study of Myelodysplastic Syndrome and Acute Myeloid Leukemia (AML), has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 4 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will determine the safety and effectiveness of an experimental vaccine in controlling the abnormal growth of cells in patients with myelodysplastic syndrome (MDS, also known as myelodysplasia), acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), and chronic myeloid leukemia (CML). It will test whether the vaccine can increase the number of immune cells responding to the cancer and thereby slow progression of the illness, improve blood counts, reduce the need for transfusions of blood and platelets, or even achieve a disease remission. The vaccine contains part of a protein that is produced in large amounts by cells of patients with these cancers and an added substance called Montanide that helps the immune system respond to the vaccine. Sargramostim, another substances that boosts the immune response, is also given. Patients 18 to 85 years of age with MDS, AML, ALL or CML may be eligible for this study. Candidates are screened with a medical history, physical examination, blood tests, chest x-ray and bone marrow biopsy. Women of childbearing age also have a pregnancy test. Participants undergo the following: * Chemotherapy entering the study. * Leukapheresis to collect large amounts of white blood cells for infusion before vaccine administration. * Participants may need placement of a central line (plastic tube, or catheter) in the upper part of the chest to be used for giving chemotherapy, blood or platelet transfusions, antibiotics and white blood cells, and for collecting blood samples. * Weekly vaccine injections for nine weeks, given in the upper arm, upper leg or abdomen. * Sargramostim injections following each vaccination. * Standard of care treatment for MDS, AML, ALL or CML, which may include blood or platelet transfusions, growth factors, and drugs to control underlying disease and potential side effects of the vaccine. * Weekly safety monitoring, including vital signs check, brief health assessment, blood tests and observation
Conditions Studied
Interventions
- DRUG WT1 Peptide Vaccine
Study Locations (1)
Maryland
- National Cancer Institute (NCI), 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2007-02 |
| Est. Completion | 2009-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00433745
The ClinicalTrials.gov registry entry for NCT00433745 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 207-participant average among 134 other Myelodysplastic Syndrome trials with a reported enrollment target (98% 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 Myelodysplastic Syndrome appearing as the primary indexed condition, and to 1 intervention - of which WT1 Peptide Vaccine is the first listed.
NCT00433745 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00433745 about?
NCT00433745 is a clinical study titled "Wilm's Tumor 1 (WT1) Peptide Vaccine for High Risk Hematologic Malignancy". This study will determine the safety and effectiveness of an experimental vaccine in controlling the abnormal growth of cells in patients with myelodysplastic syndrome (MDS, also known as myelodysplasia), acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), and chronic myeloid leukemia ...
What is the current status of trial NCT00433745?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 4 participants. The study started on 2007-02. Estimated completion is 2009-11.
What conditions does trial NCT00433745 study?
This clinical trial studies the following conditions: Myelodysplastic Syndrome, Acute Myeloid Leukemia (AML), Chronic Myeloid Leukemia (CML).
What interventions are being tested in trial NCT00433745?
The interventions under investigation include: WT1 Peptide Vaccine (DRUG).
Who is sponsoring clinical trial NCT00433745?
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 NCT00433745 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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