Status:
COMPLETED
GM-CSF Vaccinations After Allogeneic Blood Stem Cell Transplantation in Patients With Advanced Myeloid Malignancies
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Brigham and Women's Hospital
Conditions:
Myelodysplastic Syndrome RAEB-I or RAEB-II
Refractory Acute Myeloid Leukemia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to investigate whether the addition of a vaccine after participants reduced intensity transplant will be safe and beneficial. The vaccine used in this trial, called GVAX, ...
Detailed Description
* This trial can be divided into three phases: 1) Pre-transplant phase; 2) Reduced intensity transplant phase; 3) Vaccination phase. * Pre-transplant phase: Once a suitable donor has been identified, ...
Eligibility Criteria
Inclusion
- AML, MDS-RAEB or RAEB-T, CML, myeloid blast crisis not in remission or CML accelerated phase. Subjects must have \> 5% blasts in bone marrow or peripheral blood prior to admission for transplant.
- HLA 6/6 matched related or unrelated donor available
- ECOG Performance Statue 0-2
- 18 years of age or older
Exclusion
- Uncontrolled infection
- Leukemia with active CNS involvement
- Serum creatinine greater than 2.0 mg/dl
- ALT or AST greater than 3 x ULN
- Total bilirubin greater than 2.0 mg/dl
- Positive HIV or HTLV-1 serology
- Prior allogeneic stem cell transplant
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00426205
Start Date
June 1 2004
End Date
September 1 2009
Last Update
February 11 2022
Active Locations (1)
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1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115