Status:
COMPLETED
Safety of Peptide Vaccination for Patients With Myelodysplastic Syndrome
Lead Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Myelodysplastic Syndrome (MDS)
Eligibility:
All Genders
18-85 years
Phase:
PHASE1
Brief Summary
This study will test whether certain patients with myelodysplastic syndrome (MDS), acute myeloid leukemia (AML) or chronic myeloid leukemia (CML) can safely be vaccinated with two peptide vaccines der...
Detailed Description
Myeloid malignancies including acute myeloid leukemia and the related disorders myelodysplastic syndrome (MDS) and myeloproliferative diseases represent a wide group of bone marrow stem cell malignanc...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Diagnosed with FAB subtypes RA, RARS MDS (Low Risk)
- OR
- Diagnosed with AML and in complete remission within 5 years of treatment with less than 5 percent marrow blasts
- OR
- Diagnosed with CML In chronic phase
- OR
- Diagnosed with MDS, AML or CML and are between 6 months-3 years following allogeneic SCT who fulfill the following criteria:
- 100 percent donor engraftment,
- less than 5 percent blasts in marrow
- normal marrow cellularity
- HLA-A0201 positive at one allele
- Ages 18 - 85 years old
- EXCLUSION CRITERIA:
- Hypoplastic MDS
- Relapsed AML
- CML in accelerated phase or blast crisis
- Relapsed MDS, AML or CML following hematopoietic stem cell transplantation
- Hb less than 9 g/dl, neutrophil count less than 1 times 10(9)/1, and/ or platelet count less than 75 times 10(9)/1
- Hypocellular bone marrow
- History of Wegener's granulomatosis
- Serologic antibody against proteinase-3 (ANCA positive)
- Previous allergic reaction to montanide adjuvant
- Positive test for HIV
- Treatment with systemic corticosteroids within 14 days prior to study entry
- Co-morbidity of such severity that it would preclude the subject's ability to tolerate protocol therapy
- Predicted survival less than 28 days
- Pregnant or breast feeding (All female subjects must have a urine pregnancy test within 1 week prior to vaccine administration)
- Enrolled in another drug or vaccine clinical trial during the study period
- Inability to comprehend the investigational nature of the study and provide informed consent
Exclusion
Key Trial Info
Start Date :
December 22 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 26 2007
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00270452
Start Date
December 22 2005
End Date
October 26 2007
Last Update
July 2 2017
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892