Decitabine

Generic Name
Decitabine
Brand Names
Dacogen, Inqovi 5 Tablet Pack
Drug Type
Small Molecule
Chemical Formula
C8H12N4O4
CAS Number
2353-33-5
Unique Ingredient Identifier
776B62CQ27
Background

Myelodysplastic syndromes (MDS) are a heterogeneous group of hematopoietic neoplasms with variable underlying etiology and presentation, including neutropenia and thrombocytopenia. Further mutations leading to increased proliferation of cancerous cells can eventually lead to secondary acute myeloid leukemia, which has a poor prognosis. Among treatment options, nucleoside analogues such as decitabine and azacitidine integrate into cellular DNA and inhibit the action of DNA methyltransferases, leading to global hypomethylation and related downstream therapeutic benefits.

Decitabine was developed by MGI Pharma/SuperGen Inc. and was approved by the FDA for the treatment of MDS on February 5, 2006. It was first marketed under the name Dacogen®. It is also available as an oral combination product together with the cytidine deaminase inhibitor cedazuridine.

Indication

Decitabine is indicated for the treatment of patients with myelodysplastic syndromes (MDS) including all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia), as well as for MDS scored as belonging to the intermediate-1, intermediate-2, or high-risk group in the International Prognostic Scoring System.

Associated Conditions
Chronic Myelomonocytic Leukemia, Myelodysplastic Syndrome
Associated Therapies
-

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

First Posted Date
2017-03-28
Last Posted Date
2024-12-17
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
78
Registration Number
NCT03092674
Locations
🇺🇸

Cancer Hematology Centers - Flint, Flint, Michigan, United States

🇺🇸

Anchorage Associates in Radiation Medicine, Anchorage, Alaska, United States

🇺🇸

Alaska Breast Care and Surgery LLC, Anchorage, Alaska, United States

and more 503 locations

The Use of Decitabine as Induction Therapy for Acute Myeloid Leukemia With Complex and/or Monosomal Karyotype

First Posted Date
2017-03-15
Last Posted Date
2021-04-28
Lead Sponsor
The University of Hong Kong
Target Recruit Count
20
Registration Number
NCT03080766
Locations
🇭🇰

The University of Hong Kong, Hong Kong, Hong Kong

Study of PDR001 and/or MBG453 in Combination With Decitabine in Patients With AML or High Risk MDS

First Posted Date
2017-02-28
Last Posted Date
2024-08-29
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
241
Registration Number
NCT03066648
Locations
🇺🇸

MD Anderson Cancer Center, Houston, Texas, United States

🇺🇸

Oregon Health Sciences University Main Center, Portland, Oregon, United States

🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

and more 1 locations

Single Agent Decitabine in TP53 Mutated Relapsed/Refractory Acute Myeloid Leukemia

First Posted Date
2017-02-24
Last Posted Date
2022-06-02
Lead Sponsor
Washington University School of Medicine
Target Recruit Count
17
Registration Number
NCT03063203
Locations
🇺🇸

Washington University School of Medicine, Saint Louis, Missouri, United States

Efficacy and Safety of Ultra Small Dose Decitabine for the Lower Risk MDS Patients With Transfusion Dependent

Phase 2
Conditions
Interventions
First Posted Date
2017-02-07
Last Posted Date
2017-02-07
Lead Sponsor
Shandong University
Target Recruit Count
50
Registration Number
NCT03045510
Locations
🇨🇳

Qilu hospital, Shandong University, Jinan, Shandong, China

🇨🇳

Shandong University Qilu Hospital, Jinan, Shandong, China

Testing a New Chemotherapy Drug, KRT-232 (AMG-232) in Combination With Decitabine and Venetoclax in Patients With Acute Myeloid Leukemia

First Posted Date
2017-02-03
Last Posted Date
2024-08-26
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
58
Registration Number
NCT03041688
Locations
🇺🇸

USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States

🇺🇸

Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States

🇺🇸

Los Angeles General Medical Center, Los Angeles, California, United States

and more 10 locations

Decitabine Versus Conventional Chemotherapy for Maintenance Therapy of Acute Myeloid Leukemia With t(8;21)

First Posted Date
2017-01-20
Last Posted Date
2017-01-20
Lead Sponsor
The First Hospital of Jilin University
Target Recruit Count
180
Registration Number
NCT03026842
Locations
🇨🇳

First Hospital of Jilin University, Changchun, Jilin, China

Efficacy of Decitabine in Clearance of MRD

Phase 1
Suspended
Conditions
Interventions
First Posted Date
2017-01-13
Last Posted Date
2019-03-22
Lead Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Target Recruit Count
300
Registration Number
NCT03021395
Locations
🇨🇳

Institute of Hematology & Blood Diseases Hospital, Tianjin, Tianjin, China

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