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

Decitabine Augments for Post Allogeneic Stem Cell Transplantation in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome

Phase 2

Conditions: Acute Myelocytic Leukemia
Myelodysplastic Syndromes

Interventions: Drug: decitabine

First Posted Date: 2013-03-12

Last Posted Date: 2013-03-12

Lead Sponsor: The First Affiliated Hospital of Soochow University

Target Recruit Count: 15

Registration Number: NCT01809392

Locations: 🇨🇳
First Affiliated Hospital, Soochow University, Suzhou, Jiangsu, China

Decitabine for Myelodysplastic Syndromes and Acute Myeloid Leukemia Before Allogeneic Hematopoietic Cell Transplantation

Phase 4

Conditions: Higher-risk Myelodysplastic Syndrome
Relapsed /Refractory Acute Myeloid Leukemia

Interventions: Drug: decitabine

First Posted Date: 2013-03-07

Last Posted Date: 2013-03-12

Lead Sponsor: The First Affiliated Hospital of Soochow University

Target Recruit Count: 30

Registration Number: NCT01806116

Lower Dose Decitabine Based Therapy in Patients With Refractory and/or Chemotherapy Resistant Solid Tumors or B Cell Lymphomas

Phase 1

Conditions: Solid Tumors
B Cell Lymphoma

Interventions: Drug: Decitabine
Biological: cytokine-induced killer cell

First Posted Date: 2013-02-26

Last Posted Date: 2016-01-28

Lead Sponsor: Han weidong

Target Recruit Count: 100

Registration Number: NCT01799083

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

AR-42 and Decitabine in Treating Patients With Acute Myeloid Leukemia

Phase 1

Completed

Conditions: Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Recurrent Adult Acute Myeloid Leukemia
Untreated Adult Acute Myeloid Leukemia
Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
Secondary Acute Myeloid Leukemia
Adult Acute Myeloid Leukemia With Del(5q)
Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
Recurrent Childhood Acute Myeloid Leukemia
Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)

Interventions: Drug: HDAC inhibitor AR-42
Drug: decitabine
Other: laboratory biomarker analysis
Other: pharmacological study

First Posted Date: 2013-02-26

Last Posted Date: 2018-03-14

Lead Sponsor: Alison Walker

Target Recruit Count: 13

Registration Number: NCT01798901

Locations: 🇺🇸
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center, Columbus, Ohio, United States
🇺🇸
Nationwide Children's Hospital, Columbus, Ohio, United States
🇺🇸
Cincinnati Children's Hospital, Cincinnati, Ohio, United States

Decitabine Followed by Clofarabine, Idarubicin, and Cytarabine in Acute Leukemia

Phase 1

Completed

Conditions: Leukemia

Interventions: Drug: Decitabine
Drug: Idarubicin
Drug: Cytarabine
Drug: Clofarabine

First Posted Date: 2013-02-20

Last Posted Date: 2019-05-30

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 65

Registration Number: NCT01794702

Locations: 🇺🇸
University of Texas MD Anderson Cancer Center, Houston, Texas, United States

Decitabine for Older or Unfit Patients With Acute Myeloid Leukemia (AML)

Phase 2

Completed

Conditions: Leukemia

Interventions: Drug: Decitabine

First Posted Date: 2013-02-07

Last Posted Date: 2020-04-15

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 74

Registration Number: NCT01786343

Locations: 🇺🇸
University of Texas MD Anderson Cancer Center, Houston, Texas, United States

Decitabine Followed by Mitoxantrone Hydrochloride, Etoposide, and Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndromes

Phase 1

Completed

Conditions: Recurrent Adult Acute Myeloid Leukemia
Previously Treated Myelodysplastic Syndrome

Interventions: Drug: Cytarabine
Drug: Decitabine
Drug: Etoposide
Other: Laboratory Biomarker Analysis
Drug: Mitoxantrone Hydrochloride

First Posted Date: 2012-11-20

Last Posted Date: 2019-02-07

Lead Sponsor: Fred Hutchinson Cancer Center

Target Recruit Count: 52

Registration Number: NCT01729845

Locations: 🇺🇸
Kadlec Clinic Hematology and Oncology, Kennewick, Washington, United States
🇺🇸
Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, United States
🇺🇸
EvergreenHealth Medical Center, Kirkland, Washington, United States