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

Associated Therapies: -

Clinical Trials

Epigenetic Reprogramming in Relapse/Refractory AML

Phase 1

Completed

Conditions: Acute Myelogenous Leukemia

Interventions: Drug: Decitabine
Drug: Vorinostat
Drug: Filgrastim (G-CSF)
Drug: Fludarabine
Drug: Cytarabine

First Posted Date: 2017-08-28

Last Posted Date: 2022-06-24

Lead Sponsor: Therapeutic Advances in Childhood Leukemia Consortium

Target Recruit Count: 37

Registration Number: NCT03263936

Locations: 🇺🇸
National Cancer Institute, Pediatric Oncology Branch, Bethesda, Maryland, United States
🇺🇸
Children's Hospital Orange County, Orange, California, United States
🇺🇸
UCSF School of Medicine, San Francisco, California, United States

and more 30 locations

Decitabine Combining Dexamethasone Versus Dexamethasone in Management of ITP

Phase 3

Conditions: Purpura, Thrombocytopenic, Idiopathic
Immune Thrombocytopenia

Interventions: Drug: Decitabine
Drug: Dexamethasone

First Posted Date: 2017-08-17

Last Posted Date: 2018-08-15

Lead Sponsor: Shandong University

Target Recruit Count: 200

Registration Number: NCT03252457

Locations: 🇨🇳
Qilu hospital, Shandong University, Jinan, Shandong, China

SHR-1210 Alone or in Combination With Decitabine in Relapsed or Refractory Hodgkin Lymphoma

Phase 2

Recruiting

Conditions: Hodgkin Lymphoma

Interventions: Drug: SHR-1210
Drug: Decitabine

First Posted Date: 2017-08-16

Last Posted Date: 2019-04-01

Lead Sponsor: Chinese PLA General Hospital

Target Recruit Count: 280

Registration Number: NCT03250962

Locations: 🇨🇳
Biotherapeutic Department of Chinese PLA General Hospital, Beijing, Beijing, China

Study of Pembrolizumab Combined With Decitabine and Pralatrexate in PTCL and CTCL

Phase 1

Recruiting

Conditions: CTCL
PTCL

Interventions: Drug: Pembrolizumab
Drug: Pralatrexate
Drug: Decitabine

First Posted Date: 2017-08-07

Last Posted Date: 2024-05-20

Lead Sponsor: University of Virginia

Target Recruit Count: 37

Registration Number: NCT03240211

Locations: 🇺🇸
University of Virginia, Charlottesville, Virginia, United States
🇺🇸
Allegheny Health Network, Pittsburgh, Pennsylvania, United States

Geriatric Assessment & Genetic Profiling to Personalize Therapy in Older Adults With Acute Myeloid Leukemia

Phase 2

Completed

Conditions: Adult Acute Myeloid Leukemia
Secondary Acute Myeloid Leukemia
Therapy-Related Acute Myeloid Leukemia

Interventions: Drug: Cytarabine
Drug: Decitabine
Drug: Idarubicin
Other: Laboratory Biomarker Analysis
Drug: Liposome-encapsulated Daunorubicin-Cytarabine
Other: Quality-of-Life Assessment
Drug: Azacitidine
Other: Questionnaire Administration
Drug: Venetoclax
Drug: glasdegib

First Posted Date: 2017-07-21

Last Posted Date: 2024-12-16

Lead Sponsor: University of Nebraska

Target Recruit Count: 75

Registration Number: NCT03226418

Locations: 🇺🇸
University of Nebraska Medical Center, Omaha, Nebraska, United States

Research for Human Umbilical Cord Mesenchymal Stem Cells (19#iSCLife®-MDS) in the Treatment of Myelodysplastic Syndrome (MDS)

Phase 1

Suspended

Conditions: Myelodysplastic Syndromes

Interventions: Biological: Allogeneic umbilical cord mesenchymal stem cells
Drug: Decitabine

First Posted Date: 2017-06-14

Last Posted Date: 2024-04-19

Lead Sponsor: Sclnow Biotechnology Co., Ltd.

Target Recruit Count: 40

Registration Number: NCT03184935

Locations: 🇨🇳
Inner Mongolia International Mongolian Hospital, Hohhot, Inner Mongolia, China

A Trial of Epigenetic Priming in Patients With Newly Diagnosed Acute Myeloid Leukemia

Phase 2

Active, not recruiting

Conditions: Acute Myeloid Leukemia
Myelodysplastic Syndromes

Interventions: Drug: Azacitidine
Drug: Decitabine
Drug: Cytarabine
Drug: Daunorubicin
Drug: Etoposide
Combination Product: ITMHA
Drug: Idarubicin
Drug: Fludarabine
Drug: Mitoxantrone
Drug: Sorafenib
Drug: Erwinia asparaginase
Drug: G-CSF
Drug: Dexrazoxane
Drug: Asparaginase Erwinia Chrysanthemi, Recombinant-Rywn
Biological: Stem Cell Transplant

First Posted Date: 2017-05-23

Last Posted Date: 2024-05-29

Lead Sponsor: St. Jude Children's Research Hospital

Target Recruit Count: 206

Registration Number: NCT03164057

Locations: 🇺🇸
Rady Children's Hospital and Health Center, San Diego, California, United States
🇺🇸
Children's Hospital of Central California, Madera, California, United States
🇺🇸
Children's Hospital of Orange County, Orange, California, United States

and more 7 locations