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

Ascorbic Acid and Chemotherapy for the Treatment of Relapsed or Refractory Lymphoma, CCUS, and Chronic Myelomonocytic Leukemia

Phase 2

Recruiting

Conditions: Clonal Cytopenia of Undetermined Significance
High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements
Recurrent Diffuse Large B-Cell Lymphoma
Recurrent Hodgkin Lymphoma
Recurrent Lymphoma
Refractory Diffuse Large B-Cell Lymphoma
Refractory Lymphoma
Chronic Myelomonocytic Leukemia

First Posted Date: 2018-02-01

Last Posted Date: 2024-08-05

Lead Sponsor: Mayo Clinic

Target Recruit Count: 80

Registration Number: NCT03418038

Locations: 🇺🇸
Mayo Clinic Health System-Eau Claire Clinic, Eau Claire, Wisconsin, United States
🇺🇸
Mayo Clinic Health Systems-Mankato, Mankato, Minnesota, United States
🇺🇸
Mayo Clinic Health System-Franciscan Healthcare, La Crosse, Wisconsin, United States

and more 1 locations

Venetoclax and Decitabine in Treating Participants With Relapsed/Refractory Acute Myeloid Leukemia or Relapsed High-Risk Myelodysplastic Syndrome

Phase 2

Active, not recruiting

Conditions: Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Recurrent Chronic Myelomonocytic Leukemia
Refractory Blastic Plasmacytoid Dendritic Cell Neoplasm
Acute Myeloid Leukemia
Blastic Plasmacytoid Dendritic Cell Neoplasm
Chronic Myelomonocytic Leukemia
Mixed Phenotype Acute Leukemia
Recurrent Blastic Plasmacytoid Dendritic Cell Neoplasm
Recurrent Mixed Phenotype Acute Leukemia
Refractory Acute Myeloid Leukemia

Interventions: Drug: Decitabine
Other: Laboratory Biomarker Analysis
Drug: Venetoclax

First Posted Date: 2018-01-19

Last Posted Date: 2024-06-20

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 235

Registration Number: NCT03404193

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

Decitabine,Cytarabine and Arsenic Trioxide for Acute Myeloid Leukemia With p53 Mutations

Phase 2

Conditions: Acute Myeloid Leukemia
P53 Mutation

Interventions: Drug: Decitabine
Drug: Arsenic Trioxide
Drug: Cytarabine

First Posted Date: 2017-12-22

Last Posted Date: 2018-01-04

Lead Sponsor: Li Junmin

Target Recruit Count: 100

Registration Number: NCT03381781

Locations: 🇨🇳
Shanghai Institute of Hematology, Shanghai, China
🇨🇳
Ruijin Hospital North, Shanghai, China
🇨🇳
Ruijin Hospital, Shanghai, China

Decitabine and Arsenic Trioxide for Myelodysplastic Syndrome(MDS)

Phase 3

Withdrawn

Conditions: Myelodysplastic Syndromes
P53 Mutation

Interventions: Drug: Decitabine
Drug: Arsenic Trioxide

First Posted Date: 2017-12-19

Last Posted Date: 2023-08-16

Lead Sponsor: Li Junmin

Registration Number: NCT03377725

Locations: 🇨🇳
Ruijin Hospital North, Shanghai, China
🇨🇳
Ruijin Hospital, Shanghai, China
🇨🇳
Shanghai Institute of Hematology, Shanghai, China

DEC-205/NY-ESO-1 Fusion Protein CDX-1401, Poly ICLC, Decitabine, and Nivolumab in Treating Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia

Phase 1

Completed

Conditions: Acute Myeloid Leukemia
Blasts 30 Percent or Less of Bone Marrow Nucleated Cells
Chronic Myelomonocytic Leukemia
High Risk Myelodysplastic Syndrome
Myelodysplastic Syndrome
Refractory Anemia

Interventions: Biological: DEC-205/NY-ESO-1 Fusion Protein CDX-1401
Drug: Decitabine
Other: Laboratory Biomarker Analysis
Biological: Nivolumab
Drug: Poly ICLC

First Posted Date: 2017-12-02

Last Posted Date: 2021-10-05

Lead Sponsor: Roswell Park Cancer Institute

Target Recruit Count: 8

Registration Number: NCT03358719

Locations: 🇺🇸
Roswell Park Cancer Institute, Buffalo, New York, United States

DLAAG in the Treatment of Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome With Blast Excess

Phase 2

Conditions: Acute Myeloid Leukemia
Myelodysplastic Syndrome

Interventions: Drug: Decitabine
Drug: Cytarabine
Drug: All-transretinoic acid
Drug: G-CSF

First Posted Date: 2017-11-29

Last Posted Date: 2017-11-29

Lead Sponsor: Shanghai Tong Ren Hospital

Target Recruit Count: 50

Registration Number: NCT03356080

Locations: 🇨🇳
The center hospital of Shanghai Fengxian District, Shanghai, China
🇨🇳
Fujian Medical University Union Hospital, Fuzhou, China
🇨🇳
First Affiliated Hospital of Zhengzhou University., Zhengzhou, China

and more 3 locations

Two Stage Study of Combination of Chemotherapy, SHR-1210 and/or Decitabine for Relapsed/Refractory PMBCLs

Phase 1

Conditions: Primary Mediastinal Large B-cell Lymphoma

Interventions: Drug: Decitabine
Drug: GVD chemotherapy
Drug: SHR-1210

First Posted Date: 2017-11-17

Last Posted Date: 2018-12-03

Lead Sponsor: Chinese PLA General Hospital

Target Recruit Count: 30

Registration Number: NCT03346642

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

Onvansertib in Combination With Either Low-dose Cytarabine or Decitabine in Adult Patients With Acute Myeloid Leukemia (AML)

Phase 1

Completed

Conditions: Acute Myeloid Leukemia

Interventions: Drug: Onvansertib
Drug: Cytarabine
Drug: Decitabine

First Posted Date: 2017-10-06

Last Posted Date: 2023-02-27

Lead Sponsor: Cardiff Oncology

Target Recruit Count: 72

Registration Number: NCT03303339

Locations: 🇺🇸
Virginia Cancer Specialists - Fairfax Office, Fairfax, Virginia, United States
🇺🇸
University of Kansas Cancer Center, Westwood, Kansas, United States
🇺🇸
University of California Los Angeles, Los Angeles, California, United States

and more 6 locations