Peptide Vaccination in Combination With Azacitidine for Patients With MDS and AML

• Status: Completed
• Trial end date: 2019-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this phase I study is to investigate the combination of hypomethylating agents with experimental peptide vaccination against four selected tumor antigens, known to be upregulated in response to hypomethylating agents, in patients with high risk myelodysplastic syndrome and acute myeloid leukemia.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daniel El Fassi; Inge Høgh Dufva
• Collaborator: Technical University of Denmark
• Treatments: Azacitidine; Vaccines

Criteria

Inclusion Criteria:

1. Participants must have received 6 courses of azacitidine and been evaluated with response to treatment.

2. Histologically confirmed high-risk MDS or AML (<30% blasts) and a normo- or hypercellular marrow after 6 courses of azacitidine.

3. Indication for continued treatment with azacitidine.

4. Age >18 years.

5. Signed consent form after receiving both written and oral information.

6. The patients must be willing to follow the scheduled treatment and sampling.

Exclusion Criteria:

1. Hypocellular bone marrow after 6 courses of azacitidine.

2. Additional active cancer disease. Participants treated for a second malignancy may be included if the patient is without evidence of disease at least 2 years after completion of treatment.

3. Participants with a known hypersensitivity to any of the active substances or to any of the excipients.

4. Participants with secondary MDS or AML

5. Severe allergies or previous anaphylactic reactions.

6. Active autoimmune disease, for example autoimmune neutropenia/ thrombocytopenia or hemolytic anemia, systemic lupus erythematosus, Sjögren's syndrome, scleroderma, myasthenia gravis, Goodpasture's syndrome, Addison's disease, Hashimoto's thyroiditis, Grave's disease.

7. Concomitant treatment with systemic immunosuppressive medications (including prednisone, methotrexate etc.). Participants are allowed to receive up to 10 mg prednisone at the days of azacitidine injection.

8. Concomitant treatment with other experimental drugs.

9. Concomitant treatment with other systemic anti-cancer therapy.

10. Pregnant or breastfeeding females.