Decitabine

Generic Name: Decitabine

Brand Names: Dacogen, Inqovi 5 Tablet Pack

Drug Type: Small Molecule

Chemical Formula: C_₈H_₁₂N_₄O_₄

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

Clinical Trials

Decitabine and Umbilical Cord Blood for Poor Graft Function Post Allo-HSCT

Phase 3

Not yet recruiting

Conditions: Poor Graft Function

Interventions: Drug: decitabine
Biological: umbilical cord blood
Drug: Granulocyte-colony stimulating factor
Drug: Recombinant human thrombopoietin / thrombopoietin receptor agonist
Drug: Recombinant human erythropoietin

First Posted Date: 2022-12-30

Last Posted Date: 2023-06-09

Lead Sponsor: The First Affiliated Hospital of Soochow University

Target Recruit Count: 100

Registration Number: NCT05669079

Low Dose Decitabine in Combination With Tirelizumab Comparison of Tirelizumab in the First-line Treatment of Advanced Esophageal Squamous Cell Carcinoma

Phase 2

Not yet recruiting

Conditions: PFS

Interventions: Drug: tirelizumab
Drug: Decitabine Injection

First Posted Date: 2022-12-06

Last Posted Date: 2022-12-06

Lead Sponsor: Fudan University

Target Recruit Count: 60

Registration Number: NCT05638984

Venetoclax in Combination With ASTX727 for the Treatment of Chronic Myelomonocytic Leukemia and Other Myelodysplastic Syndrome/Myeloproliferative Neoplasm

Phase 2

Recruiting

Conditions: Chronic Myelomonocytic Leukemia
Myelodysplastic Syndrome
Myelodysplastic Syndrome With Excess Blasts
Myelodysplastic/Myeloproliferative Neoplasm
Myeloproliferative Neoplasm

Interventions: Procedure: Biospecimen Collection
Procedure: Bone Marrow Aspiration
Procedure: Bone Marrow Biopsy
Drug: Decitabine and Cedazuridine
Drug: Venetoclax

First Posted Date: 2022-11-01

Last Posted Date: 2025-04-24

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 132

Registration Number: NCT05600894

Locations: 🇺🇸
University of Maryland/Greenebaum Cancer Center, Baltimore, Maryland, United States
🇺🇸
NYP/Weill Cornell Medical Center, New York, New York, United States
🇺🇸
Mayo Clinic Hospital in Arizona, Phoenix, Arizona, United States

and more 31 locations

HEC73543 Versus Salvage Chemotherapy in R/R FLT3-ITD AML

Phase 3

Recruiting

Conditions: Leukemia, Acute Myeloid (AML)

Interventions: Drug: Clifutinib
Drug: LoDAC
Drug: Azacitidine
Drug: Decitabine
Drug: Ara-C±IDA
Drug: FLAG-IDA

First Posted Date: 2022-10-19

Last Posted Date: 2025-04-09

Lead Sponsor: Sunshine Lake Pharma Co., Ltd.

Target Recruit Count: 324

Registration Number: NCT05586074

Locations: 🇨🇳
the First Affiliated Hospital,College of Medicine,Zhejiang University, Hanzhou, China

Navitoclax in Relapsed or Refractory High-Risk Myelodysplastic Syndrome

Phase 1

Active, not recruiting

Conditions: Myelodysplastic Syndrome
Recurrent Myelodysplastic Syndrome
Refractory Myelodysplastic Syndrome

Interventions: Biological: Navitoclax
Drug: Venetoclax
Drug: Decitabine
Procedure: Bone Marrow Biopsy
Procedure: Biospecimen Collection
Other: Laboratory Biomarker Analysis
Other: Quality-of-Life Assessment

First Posted Date: 2022-10-03

Last Posted Date: 2025-02-11

Lead Sponsor: Thomas Jefferson University

Target Recruit Count: 6

Registration Number: NCT05564650

Locations: 🇺🇸
Sidney Kimmel Cancer Center at Thomas Jefferson University, Philadelphia, Pennsylvania, United States

MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial)

Phase 2

Recruiting

Conditions: Myelodysplastic Syndrome
Acute Myeloid Leukemia

Interventions: Procedure: Biospecimen Collection
Drug: Azacitidine
Other: Best Practice
Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
Procedure: Bone Marrow Aspiration
Procedure: Biopsy Procedure
Drug: Cytarabine
Procedure: Mutation Carrier Screening
Drug: Decitabine and Cedazuridine
Procedure: Bone Marrow Biopsy
Procedure: Echocardiography Test
Drug: Enasidenib
Drug: Venetoclax
Drug: Gilteritinib
Procedure: Multigated Acquisition Scan
Drug: Daunorubicin Hydrochloride
Drug: Liposome-encapsulated Daunorubicin-Cytarabine
Drug: Busulfan
Procedure: Chest Radiography
Procedure: Computed Tomography
Drug: Fludarabine
Drug: Gemtuzumab Ozogamicin
Drug: Melphalan
Procedure: Positron Emission Tomography
Drug: Placebo Administration
Radiation: Total-Body Irradiation

First Posted Date: 2022-10-03

Last Posted Date: 2025-05-21

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 2000

Registration Number: NCT05564390

Locations: 🇺🇸
Washington University School of Medicine, Saint Louis, Missouri, United States
🇺🇸
Mercy Hospital South, Saint Louis, Missouri, United States
🇺🇸
Siteman Cancer Center-South County, Saint Louis, Missouri, United States

and more 275 locations

Combination of Fedratinib and Decitabine for Myeloproliferative Neoplasms (MPN)- Accelerated Phase (AP)/Blast Phase (BP)

Phase 1

Terminated

Conditions: Myeloproliferative Neoplasm

Interventions: Drug: Fedratinib Oral Capsule 300 mg
Drug: Decitabine 20 mg/m2
Drug: Fedratinib Oral Capsule 400 mg

First Posted Date: 2022-09-01

Last Posted Date: 2024-04-23

Lead Sponsor: Joseph Jurcic

Target Recruit Count: 2

Registration Number: NCT05524857

Locations: 🇺🇸
New York Presbyterian Hospital/Columbia University Irving Medical Center, New York, New York, United States

Combination Navitoclax, Venetoclax and Decitabine for Advanced Myeloid Neoplasms

Phase 1

Active, not recruiting

Conditions: Myeloid Malignancy
Myelodysplastic Syndromes
Myelofibrosis
Acute Myeloid Leukemia
Myeloproliferative Neoplasm

Interventions: Drug: Navitoclax
Drug: Venetoclax
Drug: Decitabine

First Posted Date: 2022-07-13

Last Posted Date: 2025-01-29

Lead Sponsor: Jacqueline Garcia, MD

Target Recruit Count: 16

Registration Number: NCT05455294

Locations: 🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
🇺🇸
Brigham and Women's Hospital, Boston, Massachusetts, United States

A Study of Bisantrene Combined With Cytarabine or With Decitabine for Adult Subjects With Extramedullary AML and MDS

Phase 1

Withdrawn

Conditions: Acute Myeloid Leukemia
Recurrent Acute Myeloid Leukemia
Refractory Acute Myeloid Leukemia
Higher Risk Myelodysplastic Syndrome
Chronic Myelomonocytic Leukemia