Therapy Detail

Therapy Name Decitabine
Synonym
Therapy Description

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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
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
ASXL1 wild-type TET2 mutant myelodysplastic/myeloproliferative neoplasm sensitive Decitabine Clinical Study - Cohort Actionable In a clinical study, myelodysplastic syndrome patients carrying TET2 mutations and wild-type ASXL1 demonstrated an increased response to treatment with the DNA hypomethylating agents Dacogen (decitabine) or Vidaza (azacitidine) compared to patients with other mutational profiles (65% vs. 44%; OR 2.37, P=0.49) (PMID: 25224413). 25224413
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
Unknown unknown colon cancer not applicable Decitabine Preclinical Actionable In a preclinical study, Decitabine, an DNA methyltransferase inhibitor, inhibited cell growth in colon cancer cell lines (PMID: 24874286). 24874286
Unknown unknown myelodysplastic syndrome not applicable Decitabine FDA approved Actionable In a Phase III trial that supported FDA approval, Dacogen (decitabine) treatment resulted in an overall response rate of 17% (15/89), with complete responses in 9% (8/89) and partial responses in 8% (7/9) of patients with myelodysplastic syndromes (PMID: 16532500). 16532500
Clinical Trial Phase Therapies Title Recruitment Status
NCT03661307 Phase Ib/II Decitabine Quizartinib and Decitabine in Treating Participants With Untreated or Relapsed FLT3-ITD Mutated Acute Myeloid Leukemia or Myelodysplastic Syndrome Recruiting
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
NCT03946670 Phase II Decitabine + MBG453 Azacitidine Azacitidine + MBG453 Decitabine A Study of MBG453 in Combination With Hypomethylating Agents in Subjects With IPSS-R Intermediate, High or Very High Risk Myelodysplastic Syndrome (MDS). Recruiting
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
NCT02332889 Phase Ib/II Decitabine Poly ICLC Phase I/II Decitabine/Vaccine Therapy in Relapsed/Refractory Pediatric High Grade Gliomas/Medulloblastomas/CNS PNETs Terminated
NCT01593670 Phase II Decitabine Aldesleukin Vorinostat Decitabine and Vorinostat Conditioning Followed by CD3-/CD19- NK Cells Infusion for High Risk Myelodysplastic Syndromes Terminated
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 Recruiting
NCT03063203 Phase II Decitabine Single Agent Decitabine in TP53 Mutated Relapsed/Refractory Acute Myeloid Leukemia Recruiting
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) Recruiting
NCT01786343 Phase II Decitabine Decitabine for Older or Unfit Patients With Acute Myeloid Leukemia (AML) Completed
NCT01794702 Phase Ib/II Idarubicin Clofarabine Cytarabine Decitabine Decitabine Followed by Clofarabine, Idarubicin, and Cytarabine in Acute Leukemia Completed
NCT01483690 Phase Ib/II Pegaspargase Methotrexate Dexamethasone Vincristine Decitabine Mitoxantrone A Pilot Study of Decitabine and Vorinostat With Chemotherapy for Relapsed ALL Terminated
NCT01720225 Phase II Decitabine Azacitidine Decitabine Versus Azacitidine in Myelodysplastic Syndrome Patients With Low and Intermediate-1 Risk Active, not recruiting
NCT02088541 Phase II Cytarabine Azacitidine Decitabine Selinexor Hydroxyurea Selinexor (KPT-330) in Older Patients With Relapsed AML Completed
NCT02073838 Phase II Decitabine Ribavirin + Vismodegib Ribavirin and Hedgehog Inhibitor With or Without Decitabine in AML Unknown status
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
NCT02920008 Phase III Decitabine Azacitidine Cytarabine Guadecitabine Phase 3 Randomized, Open-Label Study of Guadecitabine vs Treatment Choice in Previously Treated Acute Myeloid Leukemia Active, not recruiting
NCT01303796 Phase III Decitabine + sapacitabine Decitabine A Study of Oral Sapacitabine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia (SEAMLESS) Completed
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 Dasatinib Mitoxantrone Vinblastine Cytarabine Tretinoin Clofarabine Teniposide Docetaxel Pazopanib Oxaliplatin Streptozocin Paclitaxel Bendamustine Mechlorethamine Mitotane Genomic Based Assignment of Therapy in Advanced Urothelial Carcinoma Recruiting
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 Recruiting
NCT02343939 Phase Ib/II Decitabine Cytarabine + Daunorubicin Entospletinib Entospletinib Monotherapy and in Combination With Chemotherapy in Adults With Acute Myeloid Leukemia (AML) Terminated
NCT03263936 Phase I Vorinostat Decitabine Cytarabine Fludarabine Filgrastim Epigenetic Reprogramming in Relapse/Refractory AML Recruiting
NCT01687400 Phase II Decitabine Genomic Predictors of Decitabine Response in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndromes Completed
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
NCT02412475 Phase I Cytarabine Sorafenib Vorinostat Filgrastim Daunorubicin Fludarabine Decitabine Epigenetic Reprogramming in Relapse AML Terminated
NCT02802267 Phase II Decitabine + Inecalcitol Decitabine Efficacy Study of Inecalcitol With Decitabine in Acute Myeloid Leukemia Patients Unfit for Standard Chemotherapy Recruiting
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
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
NCT02469415 Phase II Decitabine Azacitidine Pacritinib Pacritinib for Patients With Lower-Risk Myelodysplastic Syndromes (MDS) Terminated
NCT01241162 Phase I Decitabine Decitabine Followed by a Cancer Antigen Vaccine for Patients With Neuroblastoma and Sarcoma Completed
NCT01483274 Phase I Decitabine Decitabine and Vaccine Therapy for Patients With Relapsed AML Following Allogeneic Stem Cell Transplantation Withdrawn
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