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Peptide Vaccination in Combination With Azacitidine for Patients With MDS and AML (AZACTA)

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ClinicalTrials.gov Identifier: NCT02750995
Recruitment Status : Recruiting
First Posted : April 26, 2016
Last Update Posted : September 1, 2017
Sponsor:
Collaborator:
Technical University of Denmark
Information provided by (Responsible Party):
Inge Høgh Dufva, Herlev Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Myelodysplastic Syndrome Acute Myeloid Leukemia Biological: NPMW-peptide vaccine Drug: Azacitidine Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Peptide Vaccination in Combination With Azacitidine for Patients With Myelodysplastic Syndrome and Acute Myeloid Leukemia - A Phase I Study
Actual Study Start Date : April 2016
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : September 2020


Arm Intervention/treatment
Experimental: Vaccination
Azacitidine + NPMW-peptide vaccine
Biological: NPMW-peptide vaccine
Peptide vaccine against long peptide sequences from NY-ESO-1, PRAME, MAGE-A3, WT-1.

Drug: Azacitidine
Standard therapy. All participants receive azacitidine 6 months prior to inclusion, which continues during the study period.
Other Name: Vidaza




Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: Through study completion, up to 24 months. ]
    The safety of combining azacitidine treatment with this peptide vaccine will be judged on basis of the reported adverse events during the study period.


Secondary Outcome Measures :
  1. Immunological evaluation [ Time Frame: weeks: 0, 1, 9, 21. Thereafter months: 12, 18, 24 ]
    Measurements of specific T-cell reactivity against the vaccine components. The immunological response observed before, during and after treatment will be evaluated and compared. Analyses will be performed both on blood and bone marrow samples.


Other Outcome Measures:
  1. Clinical efficacy [ Time Frame: Months: 6, 12, 18, 24 ]
    The clinical efficacy of the treatment will be judged by the objective response rate according to the IWG modified response criteria, transfusion requirements and time to progression and survival.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02750995


Contacts
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Contact: Jytte Kock, Nurse +45 38682129 jytte.kock@regionh.dk
Contact: Staffan Holmberg, MD +45 60744083 staffan.holmberg@regionh.dk

Locations
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Denmark
Dept of Hematology, Herlev Hospital Recruiting
Herlev, Denmark, 2730
Contact: Jytte Kock, Nurse    +45 38682129    jytte.kock@regionh.dk   
Contact: Staffan Holmberg, MD    +45 60744083    staffan.holmberg@regionh.dk   
Principal Investigator: Inge Høgh Dufva, Lector         
Sub-Investigator: Staffan Holmberg, MD         
Sub-Investigator: Anne Ortved Gang, MD         
Sponsors and Collaborators
Inge Høgh Dufva
Technical University of Denmark
Investigators
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Principal Investigator: Inge Høgh Dufva, Lector Herlev Hospital

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Responsible Party: Inge Høgh Dufva, Clinical Associate Professor, Herlev Hospital
ClinicalTrials.gov Identifier: NCT02750995     History of Changes
Other Study ID Numbers: AZACTA
First Posted: April 26, 2016    Key Record Dates
Last Update Posted: September 1, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified participant data for primary, secondary and tertiary outcome measurements will be made available within 6 months of study completion.

Keywords provided by Inge Høgh Dufva, Herlev Hospital:
myelodysplastic syndrome
acute myeloid leukemia
azacitidine
peptide vaccine
cancer testis antigen
cancer vaccine
immunotherapy
combination therapy
NY-ESO-1
PRAME
MAGE-A3
WT-1
vaccine

Additional relevant MeSH terms:
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Syndrome
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Preleukemia
Disease
Pathologic Processes
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Vaccines
Azacitidine
Immunologic Factors
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors