Peptide Vaccination in Combination With Azacitidine for Patients With MDS and AML (AZACTA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02750995|
Recruitment Status : Recruiting
First Posted : April 26, 2016
Last Update Posted : September 1, 2017
|Condition or disease||Intervention/treatment||Phase|
|Myelodysplastic Syndrome Acute Myeloid Leukemia||Biological: NPMW-peptide vaccine Drug: Azacitidine||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Azacitidine + NPMW-peptide vaccine
Biological: NPMW-peptide vaccine
Peptide vaccine against long peptide sequences from NY-ESO-1, PRAME, MAGE-A3, WT-1.
Standard therapy. All participants receive azacitidine 6 months prior to inclusion, which continues during the study period.
Other Name: Vidaza
- 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.
- 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.
- 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.
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
|Contact: Jytte Kock, Nurse||+45 email@example.com|
|Contact: Staffan Holmberg, MD||+45 firstname.lastname@example.org|
|Dept of Hematology, Herlev Hospital||Recruiting|
|Herlev, Denmark, 2730|
|Contact: Jytte Kock, Nurse +45 38682129 email@example.com|
|Contact: Staffan Holmberg, MD +45 60744083 firstname.lastname@example.org|
|Principal Investigator: Inge Høgh Dufva, Lector|
|Sub-Investigator: Staffan Holmberg, MD|
|Sub-Investigator: Anne Ortved Gang, MD|
|Principal Investigator:||Inge Høgh Dufva, Lector||Herlev Hospital|