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. 2020 Jun 26;9(6):1559. doi: 10.3390/cells9061559

Table 3.

Selected Clinical Trials investigating tumor vaccination in myeloid malignancies.

Trial Treatment Diagnosis Outcome Measures Status,
Response,
Comments
NCT03566446
(Phase I)
CALRLong36 peptide (Ex 9 mut) vaccine CALR-mutant MPN (ET, PMF, MPN unclassifiable) Primary: AE;
Secondary: Immune response (T-cell cytokine release), mutation status, ORR
Active;
No trial results posted yet; CALRLong36 peptide did show prompt responses in vitro
NCT01266083
(Phase II)
WT1 peptide vaccine AML, ALL; patients being in CR; patients with WT1+ disease Primary: AE, OS;
Secondary: DFS, Immunol. ogic response, effects on MRD, OS
Completed;
Vaccine was well tolerated; AEs: injection site reaction, fatigue, skin induration; vaccine-stimulated specific immune response
NCT02750995
(Phase I)
NPMW-peptide vaccine (against long peptide sequences from NY-ESO-1, PRAME, MAGE-A3, WT-1);
Azacitidine
High-risk MDS, AML (<30% blasts) Primary: AE;
Secondary: specific T-cell reactivity, ORR
Recruiting
NCT03358719
(Phase I)
DEC-205/NY-ESO-1 Fusion Protein CDX-1401;
Decitabine;
Nivolumab
AML (<30% blasts), MDS, high-risk MDS, CMML, refractory anemia Primary: AE;
Secondary: immune profile, PB and BM response, CRR, PRR
Active; final data collection for primary outcome measure

AE: adverse events; AML: Acute myeloid leukemia; ALL: Acute lymphoblastic leukemia; BM: bone marrow; CMML: chronic myelomonocytic leukemia; CR: complete remission; CRR: complete response rate; DFS: disease-free survival; MDS: Myelodysplastic Syndrome; MPN: myeloproliferative neoplasm; ORR: overall response rate; OS: overall survival; PB: peripheral blood; PMF: primary myelofibrosis; PRR: partial remission rate.