Overview of clinical characteristics of patients enrolled in a phase 1 trial of decitabine given in combination with nivolumab in conjunction with vaccination against NY-ESO-1 (ClinicalTrials.govidentifier: NCT03358719)
| Patient . | Age, y . | Pathological diagnosis . | IPSS-R . | Baseline cytogenetics . | EOS cytogenetics . | Baseline BM blasts . | EOS BM blasts . | Study cycles completed . | Best response on study . |
|---|---|---|---|---|---|---|---|---|---|
| 1DVN | 74 | MDS-MLD | Very high (6.5) | Complex; >3 abnormalities | NA | 3 | NA | 2 | PD |
| 2DVN | 71 | AML-MRC | NA | 47, XY, +8 [20] | NA | 25 | NA | 0 | NA |
| 3DVN | 85 | MDS-EB-2 | Int (4) | 45,X,-Y [5] 46,XY [21] | 45,X,-Y [4] 46,XY [16] | 27 | 5 | 4 | CR |
| 4DVN | 56 | t-MDS | Int (3) | Complex; >2 abnormalities | 46,XX [19] | 1 | 1 | 1 | CR |
| 5DVN | 80 | AML-MRC | High (5) | 46,XY [5] | 46,XY [20] | 22 | 9 | 4 | SD |
| 6DVN | 72 | MDS-MLD | Very high (6.5) | Complex; >3 abnormalities, >2 clones | Complex; >3 abnormalities, >2 clones | 2 | 2 | 4 | SD |
| 7DVN | 69 | MDS-SLD | Int (3.5) | 46,XX [20] | NA | 3 | NA | 2 | SD |
| 8DVN | 66 | MDS-EB-2 | Very high (8) | Complex; >3 abnormalities, >2 clones | Complex; >2 abnormalities, >1 clones | 10 | 5 | 4 | SD |
| Patient . | Age, y . | Pathological diagnosis . | IPSS-R . | Baseline cytogenetics . | EOS cytogenetics . | Baseline BM blasts . | EOS BM blasts . | Study cycles completed . | Best response on study . |
|---|---|---|---|---|---|---|---|---|---|
| 1DVN | 74 | MDS-MLD | Very high (6.5) | Complex; >3 abnormalities | NA | 3 | NA | 2 | PD |
| 2DVN | 71 | AML-MRC | NA | 47, XY, +8 [20] | NA | 25 | NA | 0 | NA |
| 3DVN | 85 | MDS-EB-2 | Int (4) | 45,X,-Y [5] 46,XY [21] | 45,X,-Y [4] 46,XY [16] | 27 | 5 | 4 | CR |
| 4DVN | 56 | t-MDS | Int (3) | Complex; >2 abnormalities | 46,XX [19] | 1 | 1 | 1 | CR |
| 5DVN | 80 | AML-MRC | High (5) | 46,XY [5] | 46,XY [20] | 22 | 9 | 4 | SD |
| 6DVN | 72 | MDS-MLD | Very high (6.5) | Complex; >3 abnormalities, >2 clones | Complex; >3 abnormalities, >2 clones | 2 | 2 | 4 | SD |
| 7DVN | 69 | MDS-SLD | Int (3.5) | 46,XX [20] | NA | 3 | NA | 2 | SD |
| 8DVN | 66 | MDS-EB-2 | Very high (8) | Complex; >3 abnormalities, >2 clones | Complex; >2 abnormalities, >1 clones | 10 | 5 | 4 | SD |
Patients are marked by an ID number. Patient 1DVN completed 2 cycles of study before electing to discontinue treatment and there was insufficient material for all correlative assessments. Patient 2DVN received a single NY-ESO-1 vaccination and was evaluated for vaccine toxicity but came off study before receiving any cytotoxic chemotherapy. Immunologic assessments were performed for patients 3-8DVN on study. IPSS-R scores (shown in parentheses) are based on the criteria described in Greenberg et al.38 Best responses were annotated using modified Cheson criteria for MDS.39 A complete description of cytogenetics and long-term clinical follow-up are shown in supplemental Table 2.
BM, bone marrow; CR, complete remission; MDS-EB-2, myelodysplastic syndrome with excess blasts 2; Int, intermediate; IPSS-R, Revised iInternational Prognostic Scoring System; MDS-MLD, myelodysplastic syndrome with multilineage dysplasia; AMLMRC, acute myeloid leukemia with myelodysplasia-related changes; NA, not available; MDS-SLD, myelodysplastic syndrome with single lineage dysplasia; SD, stable disease; t-MDS, therapy-related myelodysplastic syndrome.