Decitabine and Vaccine Therapy for Patients With Relapsed AML Following Allogeneic Stem Cell Transplantation
Withdrawn before enrolling · Phase 1
Conditions studied: Acute Myelogenous Leukemia
In brief
Patients with Acute Myelogenous Leukemia (AML) who relapse after an allogeneic stem cell transplant cell receive decitabine to up regulate cancer antigen expression, followed by a donor lymphocyte infusion and an autologous dendritic cell (DC). Vaccine Dendritic cells are pulsed with overlapping peptides derived from MAGE-A1, MAGE-A3, and NY-ESO-1.
Key facts
- Study ID
- NCT01483274
- Run by
- University of Louisville
- People needed
- 0
- Starts
- 2015-03-01
- Expected to finish
- 2015-06-01
- Last updated by the study team
- 2017-05-09
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Patient has a history of autoimmune disease, specifically inflammatory bowel disease, systemic lupus erythematosis, or rheumatoid arthritis.
- Patient has a known systemic hypersensitivity to DAC, imiquimod, or any vaccine component.
- Patient has evidence of recurrent leukemia.
- Patient is receiving systemic corticosteroids or other immunosuppression.
- Persistent clinically significant toxicity from prior anticancer therapy that is > Grade 2 (NCI CTCAE v3.0).
- Pregnant or lactating females are excluded.
- Other active systemic malignancy other than leukemia expected to require therapy within 4 months.
- Patients with a systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).
- Any condition which, in the opinion of the investigator, would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results.
- Patients with a positive result for any of the following diagnostic tests: Hep B Ag, Hep B Core Ab, Hep C Ab, HIV-1 Ab, HIV-2 Ab, HTLV-1 Ab, HTLV-2 Ab, RPR.
- Received any investigational new drug within 30 days prior to the first dose of vaccine , or are scheduled to receive an investigational new during the course of the study
Where it is running
- University of Louisville — Louisville, Kentucky, United States
Full record on ClinicalTrials.gov
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