Decitabine and Vaccine Therapy for Patients With Relapsed AML Following Allogeneic Stem Cell Transplantation

Phase 1

Withdrawn

• Conditions: Acute Myelogenous Leukemia
• Interventions: Biological: Vaccine

• Registration Number: NCT01483274
• Lead Sponsor: University of Louisville

Brief Summary

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.

Detailed Description

For vaccine production, mature DC will be pulsed with overlapping peptides mixes derived from full-length NY-ESO-1, MAGE-A1, and MAGE-A3.

Study Timeline

• Study First Submitted: 2011-11-03
• Study First Submitted QC: 2011-11-30
• Study First Posted: 2011-12-01
• Study Start: 2015-03
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-08
• Last Update Posted: 2017-05-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Safety	Vaccine	Decitabine and donor lymphocyte infused dendritic cell (DC).
Vaccine	Vaccine	Decitabine and Dendritic cell (DC) pulsed with MAGE-A1, MAGE-A3, NY-ESO-1 Peptides

Primary Outcome Measures

Name	Time	Method
Tolerance of study treatment	4 years	Tolerance to DAC, at least 50% dosing, and 3 of the 4 planned vaccinations during the first two cycles

Secondary Outcome Measures

Name	Time	Method
Immune Response	4 years	Assessment of post-vaccination T cell responses to MAGE-A1, MAGE-A3, and NY-ESO-1 by immunoassay
Disease Response	4 years	Assessment of Bone Marrow aspiration to check for complete or partial remission, stable disease, and disease progression by bone marrow draws at week 6 and week 12.

Trial Locations

Locations (1)

University of Louisville; 🇺🇸 Louisville, Kentucky, United States