Table 5.
Decitabine clinical trials in leukemia children
| Number | Abbreviated title | NCT number | Age | Sponsor |
|---|---|---|---|---|
| 1 | Decitabine + cytarabine in R/R AML | 01853228 | 1 month to 18 years | Jannsen Pharma |
| 2 | Decitabine in R/R AML or ALL | 00042796 | ≤21 years | NCI |
| 3 | Decitabine + genistein in ped R/R malignancies | 02499861 | 2–21 years | St Justine’s Hospital |
| 4 | Epigenetic reprogramming in relapsed AML | 02412475 | ≤25 years | Medical College Wisconsin |
| 5 | Decitabine + vorinostat + CT in relapsed ALL | 1483690 | 1–21 years | TACLC |
| 6 | AR-42 + decitabine in AML | 01798901 | ≥3 years | OSUCCC |
| 7 | Decitabine + vorinostat + CT in R/R ALL or LL | 00882206 | 2–60 years | University of Minnesota |
| 8 | Low-dose decitabine in R/R ALL | 00349596 | ? | MD Anderson Cancer Center |
| 9 | Decitabine + GO in AML and HR MDS | 00882102 | ≥16 years | MD Anderson Cancer Center |
| 10 | Decitabine + valproic acid in R/R leukemia and MDS | 00075010 | ≥2 years | MD Anderson Cancer Center |
| 11 | Imatinib + decitabine in CML | 00054431 | ? | NCI |
| 12 | Decitabine for MDS and AML before allo-HSCT | 01806116 | 8–65 years | Soochow Hospital, People’s Republic of China |
| 13 | Decitabine + PBSCT in relapsed leukemia, MDS, CML after BMT | 00002832 | ≤60 years | MD Anderson Cancer Center |
| 14 | Decitabine with induction CT in AML | 01177540 | 1–16 years | Eisai Pharma |
| 15 | Decitabine with or without valproic acid in MDS and AML | 00414310 | ? | MD Anderson Cancer Center |
| 16 | Decitabine + GO in AML and HR MDS | 00968071 | ≥16 years | MD Anderson Cancer Center |
| 17 | Decitabine in blast-phase CML relapsed to imatinib | 00042003 | ≥2 years | Astex Pharma |
| 18 | Decitabine in CML relapsed to imatinib | 00042016 | ≥2 years | Astex Pharma |
| 19 | Decitabine in CML relapsed to imatinib | 00041990 | ≥2 years | Astex Pharma |
| 20 | Decitabine for maintenance after first CT for AML | 00416598 | 15–59 years | NCI |
| 21 | Decitabine in AML and MDS after allo-HSCT | 02264873 | 1–30 years | University of Florida |
| 22 | Decitabine and two CT regimens in AML | 00943553 | 1–16 years | Eisai Pharma |
| 23 | CT + PBSCT in CML or acute leukemia | 00002831 | 15–55 years | MD Anderson Cancer Center |
| 24 | Phase I, dose-escalation study of decitabine | 00067808 | ? | MD Anderson Cancer Center |
| 25 | Decitabine in MDS after azacytidine failure | 00113321 | 18–85 years | MD Anderson Cancer Center |
| 26 | Decitabine in MDS | 00003361 | ≥15 years | MSKCC |
| 27 | CHG vs decitabine in HR MDS | 01417767 | 16–80 years | Shanghai Hospital, People’s Republic of China |
| 28 | Decitabine + cytarabine in MDS | 01674985 | 10–90 years | CAMMS |
| 29 | Decitabine in MDS | 02060409 | 17–90 years | Samsung Medical Center |
Notes: The search terms “decitabine leukemia children” gave 28 hits; two were in patients ≥60 years and were removed (NCT02085408 and NCT01041703). Studies number 27–29 came up with the search terms “decitabine children”, and as they aim at MDS and include also pediatric patients, they were added.
Abbreviations: NCT, National Clinical Trial; R/R, relapsed or refractory; AML, acute myeloid leukemia; ALL, acute lymphoblastic leukemia; NCI, National Cancer Institute; CT, chemotherapy; TACLC, Therapeutic Advances in Childhood Leukemia Consortium; OSUCCC, Ohio State University Comprehensive Cancer Center; LL, lymphoblastic lymphoma; GO, gemtuzumab ozogamicin; HR, high-risk; MDS, myelodysplastic syndrome; CML, chronic myeloid leukemia; HSCT, hematopoietic stem cell transplantation; PBSCT, peripheral blood stem cell transplantation; BMT, bone marrow transplantation; MSKCC, Memorial Sloan Kettering Cancer Center; CAMMS, Chinese Academy of Military Medical Sciences.