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Therapy Name | Decitabine |
Synonyms | |
Therapy Description |
Dacogen (decitabine) is cytidine analog that incorporates into DNA and forms covalent bonds with DNA methyltransferases (DNMTs), resulting in decreased DNMT activity and hypomethylation, and potentially leading to reduced tumor growth (PMID: 28159832, PMID: 25130173). Dacogen (decitabine) is FDA approved for use in patients with myelodysplastic syndromes (FDA.gov). |
Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
---|---|---|---|---|
Decitabine | Dacogen | 5-aza-2-deoxycytidine | DNMT inhibitor (Pan) 5 | Dacogen (decitabine) is cytidine analog that incorporates into DNA and forms covalent bonds with DNA methyltransferases (DNMTs), resulting in decreased DNMT activity and hypomethylation, and potentially leading to reduced tumor growth (PMID: 28159832, PMID: 25130173). Dacogen (decitabine) is FDA approved for use in patients with myelodysplastic syndromes (FDA.gov). |
Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
---|---|---|---|---|---|---|---|
IDH2 mutant | acute myeloid leukemia | sensitive | Decitabine | Guideline | Actionable | Dacogen (decitabine) is included in guidelines for adult patients with acute myeloid leukemia harboring an IDH2 mutation (NCCN.org). | detail... |
TP53 mutant | acute myeloid leukemia | sensitive | Decitabine | Guideline | Actionable | Dacogen (decitabine) is included in guidelines for adult patients with acute myeloid leukemia harboring a TP53 mutation (NCCN.org). | detail... |
RB1 del | prostate adenocarcinoma | sensitive | Decitabine | Preclinical - Cell line xenograft | Actionable | In a preclinical study, Dacogen (decitabine) inhibited viability of castration-resistant prostate adenocarcinoma cells with loss of RB1 via knockout in culture and inhibited tumor growth in cell line xenograft models (PMID: 37967200). | 37967200 |
IDH1 R132H | oligodendroglioma | sensitive | Decitabine | Preclinical - Pdx & cell culture | Actionable | In a preclinical study, Dacogen (decitabine) decreased colony formation and tumor growth in patient derived xenograft (PDX) models of patient derived oligodendroglioma cells with IDH1 R132H mutations and co-deletion of 1p and 19q (PMID: 24077826). | 24077826 |
IDH1 mutant | acute myeloid leukemia | sensitive | Decitabine | Guideline | Actionable | Dacogen (decitabine) is included in guidelines for adult patients with acute myeloid leukemia harboring an IDH1 mutation (NCCN.org). | detail... |
DNMT3A mutant | acute myeloid leukemia | predicted - sensitive | Decitabine | Clinical Study - Cohort | Actionable | In a clinical study, acute myeloid leukemia patients harboring DNMT3A mutations demonstrated a greater complete response rate (60% vs 33%) compared to patients with wild-type DNMT3A when treated with frontline hypomethylating agents such as Dacogen (decitabine) (PMID: 27418649). | 27418649 |
Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
---|---|---|---|---|---|---|
NCT03092674 | Phase II | Cytarabine + Decitabine Azacitidine + Midostaurin Decitabine Azacitidine + Nivolumab Azacitidine | Azacitidine With or Without Nivolumab or Midostaurin, or Decitabine and Cytarabine Alone in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome | Active, not recruiting | USA | 0 |
NCT01786343 | Phase II | Decitabine | Decitabine for Older or Unfit Patients With Acute Myeloid Leukemia (AML) | Completed | USA | 0 |
NCT02348489 | Phase III | Guadecitabine Cytarabine Azacitidine Decitabine | SGI-110 in Adults With Untreated Acute Myeloid Leukemia (AML), Not Considered Candidates for Intensive Remission Induction | Completed | USA | SWE | ROU | POL | NLD | ITA | HUN | GBR | FRA | FIN | ESP | DNK | DEU | CZE | CAN | BGR | BEL | AUT | AUS | 5 |
NCT03926624 | Phase III | Decitabine + Venetoclax Azacitidine + Venetoclax Cytarabine + Filgrastim + Fludarabine + Idarubicin Cytarabine + Venetoclax Cytarabine + Filgrastim + Fludarabine Decitabine Azacitidine Cladribine + Cytarabine + Filgrastim + Mitoxantrone DFP-10917 Cladribine + Cytarabine + Filgrastim + Idarubicin Cytarabine Cytarabine + Etoposide + Mitoxantrone | Trial of DFP-10917 vs Non-Intensive or Intensive Reinduction for AML Patients in 2nd/3rd/4th Salvage | Unknown status | USA | 0 |
NCT03306264 | Phase III | Decitabine Decitabine and Cedazuridine | Study of ASTX727 vs IV Decitabine in MDS, CMML, and AML | Completed | USA | ITA | HUN | GBR | FRA | ESP | DEU | CZE | CAN | AUT | 0 |
NCT01794702 | Phase Ib/II | Idarubicin Clofarabine Cytarabine Decitabine | Decitabine Followed by Clofarabine, Idarubicin, and Cytarabine in Acute Leukemia | Completed | USA | 0 |
NCT02802267 | Phase II | Decitabine + Inecalcitol Decitabine | Efficacy Study of Inecalcitol With Decitabine in Acute Myeloid Leukemia Patients Unfit for Standard Chemotherapy | Unknown status | USA | FRA | 0 |
NCT02412475 | Phase I | Cytarabine Sorafenib Vorinostat Filgrastim Daunorubicin Fludarabine Decitabine | Epigenetic Reprogramming in Relapse AML | Terminated | USA | 0 |
NCT03263936 | Phase I | Vorinostat Decitabine Cytarabine Fludarabine Filgrastim | Epigenetic Reprogramming in Relapse/Refractory AML | Completed | USA | CAN | AUS | 0 |
NCT01303796 | Phase III | Decitabine + Sapacitabine Decitabine | A Study of Oral Sapacitabine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia (SEAMLESS) | Completed | USA | SWE | POL | ITA | HUN | GBR | FRA | ESP | DEU | CHE | BEL | AUT | 0 |
NCT01515527 | Phase II | Cytarabine Cladribine Decitabine | Cladribine Plus Low Dose Cytarabine (LDAC) Alternating With Decitabine in Patients With Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndrome (MDS) | Recruiting | USA | 0 |
NCT01483690 | Phase Ib/II | Pegaspargase Methotrexate Dexamethasone Vincristine Sulfate Decitabine Mitoxantrone | A Pilot Study of Decitabine and Vorinostat With Chemotherapy for Relapsed ALL | Terminated | USA | AUS | 0 |
NCT01483274 | Phase I | Decitabine | Decitabine and Vaccine Therapy for Patients With Relapsed AML Following Allogeneic Stem Cell Transplantation | Withdrawn | USA | 0 |
NCT02469415 | Phase II | Decitabine Azacitidine Pacritinib | Pacritinib for Patients With Lower-Risk Myelodysplastic Syndromes (MDS) | Terminated | USA | 0 |
NCT04229979 | Phase III | Galinpepimut-S Cytarabine Decitabine Venetoclax Azacitidine | Galinpepimut-S Versus Investigator's Choice of Best Available Therapy for Maintenance in AML CR2/CRp2 (REGAL) | Active, not recruiting | USA | POL | HUN | GRC | FRA | ESP | DEU | 3 |
NCT02551718 | Phase I | Bosutinib Irinotecan Romidepsin Busulfan Melphalan Nilotinib Crizotinib Cytarabine Mitoxantrone Dasatinib Pazopanib Paclitaxel Clofarabine Hydroxyurea Tretinoin Carfilzomib Nelarabine Bexarotene Pentostatin Everolimus Cabozantinib Mercaptopurine Methotrexate Cladribine Thioguanine Daunorubicin Ponatinib Etoposide Afatinib Gefitinib Gemcitabine Regorafenib Arsenic trioxide Trametinib Imatinib Erlotinib Dabrafenib Decitabine Axitinib Azacitidine Ruxolitinib Fludarabine Lapatinib Ceritinib Sirolimus Sorafenib Lomustine Sunitinib Cabazitaxel Temsirolimus Topotecan Bortezomib Pralatrexate | High Throughput Drug Sensitivity Assay and Genomics- Guided Treatment of Patients With Relapsed or Refractory Acute Leukemia | Completed | USA | 0 |
NCT02920008 | Phase III | Decitabine Azacitidine Cytarabine Guadecitabine | Phase 3 Randomized, Open-Label Study of Guadecitabine vs Treatment Choice in Previously Treated Acute Myeloid Leukemia | Completed | USA | SWE | POL | ITA | HUN | GBR | FRA | ESP | DNK | DEU | CAN | BEL | 3 |
NCT01593670 | Phase II | Decitabine Aldesleukin Vorinostat | Decitabine and Vorinostat Conditioning Followed by CD3-/CD19- NK Cells Infusion for High Risk Myelodysplastic Syndromes | Completed | USA | 0 |
NCT01707004 | Phase I | Cyclophosphamide Decitabine Filgrastim Fludarabine Busulfan | Decitabine and Total-Body Irradiation Followed By Donor Bone Marrow Transplant and Cyclophosphamide in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia | Completed | USA | 0 |
NCT01546038 | Phase Ib/II | Glasdegib Cytarabine Decitabine Cytarabine + Daunorubicin | A Study To Evaluate PF-04449913 With Chemotherapy In Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome | Completed | USA | POL | ITA | ESP | DEU | CAN | 0 |
NCT02632721 | Phase II | BI 836858 + Decitabine Decitabine | A Study to Find and Investigate a Safe Dose of BI 836858 in Combination With Decitabine for Patients With Acute Myeloid Leukemia (AML) | Completed | USA | ITA | ESP | DEU | 0 |
NCT01993641 | Phase II | Pracinostat Azacitidine Decitabine | Phase 2 Study Adding Pracinostat to a Hypomethylating Agent (HMA) in Patients With MDS Who Failed to Respond to Single Agent HMA | Completed | USA | 0 |
NCT01729845 | Phase Ib/II | Cytarabine + Etoposide + Mitoxantrone Decitabine | Decitabine Followed By Mitoxantrone Hydrochloride, Etoposide, and Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndromes | Completed | USA | 0 |
NCT02332889 | Phase Ib/II | Decitabine Poly ICLC | Phase I/II Decitabine/Vaccine Therapy in Relapsed/Refractory Pediatric High Grade Gliomas/Medulloblastomas/CNS PNETs | Terminated | USA | 0 |
NCT02088541 | Phase II | Cytarabine Azacitidine Decitabine Selinexor Hydroxyurea | Selinexor (KPT-330) in Older Patients With Relapsed AML | Completed | USA | POL | NLD | ITA | ISR | GBR | FRA | ESP | DNK | DEU | CAN | 0 |
NCT02073838 | Phase II | Decitabine Ribavirin + Vismodegib | Ribavirin and Hedgehog Inhibitor With or Without Decitabine in AML | Completed | CAN | 0 |
NCT03946670 | Phase II | Decitabine + Sabatolimab Azacitidine Azacitidine + Sabatolimab Decitabine | A Study of MBG453 in Combination With Hypomethylating Agents in Subjects With IPSS-R Intermediate, High or Very High Risk Myelodysplastic Syndrome (MDS). | Completed | USA | TUR | ITA | HUN | GRC | GBR | FRA | ESP | DEU | CZE | CAN | BEL | AUT | 4 |
NCT02788201 | Phase II | Erlotinib Thiotepa Imatinib Dacarbazine Arsenic trioxide Idarubicin Mitomycin C Thioguanine Mercaptopurine Methotrexate Cladribine Epirubicin Gemcitabine Doxorubicin Bleomycin Etoposide Gefitinib Daunorubicin Lomustine Sorafenib Sunitinib Ifosfamide Asparaginase Ixabepilone Abiraterone Azacitidine Ruxolitinib Decitabine Axitinib Estramustine Floxuridine Lapatinib Carmustine Fludarabine Nilotinib Cisplatin Vismodegib Vandetanib Melphalan Busulfan Carboplatin Toremifene Crizotinib Dactinomycin Temsirolimus Vorinostat Romidepsin Fluorouracil Irinotecan Bortezomib Tamoxifen Topotecan Chlorambucil Pentostatin Eribulin Carfilzomib Vemurafenib Hydroxyurea Exemestane Vincristine Sulfate Dasatinib Mitoxantrone Vinblastine Cytarabine Tretinoin Clofarabine Teniposide Docetaxel Pazopanib Oxaliplatin Streptozocin Paclitaxel Bendamustine Mechlorethamine Mitotane | Genomic Based Assignment of Therapy in Advanced Urothelial Carcinoma | Completed | USA | 0 |
NCT02472145 | Phase III | Decitabine Decitabine + Talacotuzumab | An Efficacy and Safety Study of Decitabine (DACOGEN) Plus Talacotuzumab (JNJ-56022473; Anti CD123) Versus Decitabine (DACOGEN) Alone in Participants With Acute Myeloid Leukemia (AML) Ineligible for Intensive Chemotherapy | Completed | USA | TUR | SWE | POL | ISR | GBR | FRA | ESP | DEU | BEL | AUS | 3 |
NCT01241162 | Phase I | Decitabine | Decitabine Followed by a Cancer Antigen Vaccine for Patients With Neuroblastoma and Sarcoma | Completed | USA | 0 |
NCT03063203 | Phase II | Decitabine | Single Agent Decitabine in TP53 Mutated Relapsed/Refractory Acute Myeloid Leukemia | Terminated | USA | 0 |
NCT02343939 | Phase Ib/II | Decitabine Cytarabine + Daunorubicin Entospletinib | Entospletinib Monotherapy and in Combination With Chemotherapy in Adults With Acute Myeloid Leukemia (AML) | Terminated | USA | DEU | CAN | 0 |
NCT01720225 | Phase II | Decitabine Azacitidine | Decitabine Versus Azacitidine in Myelodysplastic Syndrome Patients With Low and Intermediate-1 Risk | Completed | USA | 0 |
NCT03164057 | Phase II | Etoposide Filgrastim Dexrazoxane Daunorubicin Idarubicin Fludarabine Asparaginase Cytarabine Sorafenib Mitoxantrone Decitabine Azacitidine | A Trial of Epigenetic Priming in Patients With Newly Diagnosed Acute Myeloid Leukemia | Active, not recruiting | USA | 0 |
NCT01687400 | Phase II | Decitabine | Genomic Predictors of Decitabine Response in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndromes | Completed | USA | 0 |