Table 3.
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.