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

Tosedostat in Combination With Cytarabine or Decitabine in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome

Phase 2

Completed

Conditions: Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
Secondary Myelodysplastic Syndromes
Acute Myeloid Leukemia With Multilineage Dysplasia
Secondary Acute Myeloid Leukemia
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Adult Acute Myeloid Leukemia With Del(5q)
Previously Treated Myelodysplastic Syndromes
Untreated Adult Acute Myeloid Leukemia
de Novo Myelodysplastic Syndromes

Interventions: Drug: tosedostat
Drug: decitabine
Drug: cytarabine

First Posted Date: 2012-03-30

Last Posted Date: 2017-02-15

Lead Sponsor: Fred Hutchinson Cancer Center

Target Recruit Count: 34

Registration Number: NCT01567059

Locations: 🇺🇸
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium, Seattle, Washington, United States

A Study To Evaluate PF-04449913 With Chemotherapy In Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome

Phase 2

Completed

Conditions: Acute Myeloid Leukemia

Interventions: Drug: PF-04449913
Drug: Low dose ARA-C (LDAC)
Drug: Daunorubicin
Drug: Decitabine
Drug: Cytarabine

First Posted Date: 2012-03-07

Last Posted Date: 2020-03-03

Lead Sponsor: Pfizer

Target Recruit Count: 255

Registration Number: NCT01546038

Locations: 🇺🇸
Keck Hospital of USC, Los Angeles, California, United States
🇺🇸
University of Kansas Cancer Center and Medical Pavilion, Westwood, Kansas, United States
🇺🇸
LAC & USC Medical Center, Los Angeles, California, United States

and more 75 locations

Cladribine Plus Low Dose Cytarabine (LDAC) Alternating With Decitabine in Patients With Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndrome (MDS)

Phase 2

Recruiting

Conditions: Leukemia

Interventions: Drug: Cladribine
Drug: Cytarabine
Drug: Decitabine

First Posted Date: 2012-01-24

Last Posted Date: 2024-06-27

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 160

Registration Number: NCT01515527

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

An Open-Label, Phase I/II Study of Two Different Schedules of Dasatinib (Sprycel) and Decitabine (Dacogen) Used in Combination for Patients With Accelerated or Blastic Phase Chronic Myelogenous Leukemia (Protocol CA180357)

Phase 1

Terminated

Conditions: Leukemia

Interventions: Drug: Dasatinib
Drug: Decitabine

First Posted Date: 2011-12-23

Last Posted Date: 2020-10-22

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 32

Registration Number: NCT01498445

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

A Pilot Study of Decitabine and Vorinostat With Chemotherapy for Relapsed ALL

Phase 1

Terminated

Conditions: Acute Lymphoblastic Leukemia
Precursor B-Cell Lymphoblastic Leukemia
Precursor T-Cell Lymphoblastic Leukemia

Interventions: Drug: Decitabine
Drug: Vorinostat
Drug: Vincristine
Drug: Dexamethasone
Drug: Mitoxantrone
Drug: Pegaspargase
Drug: Methotrexate

First Posted Date: 2011-12-01

Last Posted Date: 2020-10-27

Lead Sponsor: Therapeutic Advances in Childhood Leukemia Consortium

Target Recruit Count: 23

Registration Number: NCT01483690

Locations: 🇺🇸
Seattle Children's Hospital, Seattle, Washington, United States
🇦🇺
Children's Hospital at Westmead, Westmead, New South Wales, Australia
🇦🇺
Sydney Children's Hospital, Sydney, Australia

and more 25 locations

Decitabine With or Without Bortezomib in Treating Older Patients With Acute Myeloid Leukemia

Phase 2

Completed

Conditions: Acute Myeloid Leukemia
Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Therapy-Related Acute Myeloid Leukemia

Interventions: Drug: Decitabine
Drug: Bortezomib
Other: Pharmacological Study
Other: Laboratory Biomarker Analysis
Other: Quality-of-Life Assessment
Other: Questionnaire Administration

First Posted Date: 2011-08-22

Last Posted Date: 2023-02-28

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 165

Registration Number: NCT01420926

Locations: 🇺🇸
NorthShore University HealthSystem-Evanston Hospital, Evanston, Illinois, United States
🇺🇸
East Carolina University, Greenville, North Carolina, United States
🇺🇸
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States

and more 50 locations

Decitabine for High-Risk Sickle Cell Disease

Phase 2

Completed

Conditions: Neutropenia
Sickle Cell Disease

Interventions: Drug: Decitabine

First Posted Date: 2011-06-17

Last Posted Date: 2017-03-01

Lead Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Target Recruit Count: 10

Registration Number: NCT01375608

Locations: 🇺🇸
National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

Decitabine and Plerixafor in Elderly Acute Myeloid Leukemia (AML)

Phase 1

Completed

Conditions: Acute Myeloid Leukemia

Interventions: Drug: plerixafor
Drug: decitabine

First Posted Date: 2011-05-12

Last Posted Date: 2018-07-02

Lead Sponsor: Weill Medical College of Cornell University

Target Recruit Count: 71

Registration Number: NCT01352650

Locations: 🇺🇸
Weill Cornell Medical College, New York, New York, United States

Study of Decitabine Induction Prior to Allogeneic Hematopoietic Cell Transplant in Newly Diagnosed MDS Patients

Phase 2

Terminated

Conditions: Myelodysplastic Syndrome

Interventions: Drug: Decitabine

First Posted Date: 2011-04-12

Last Posted Date: 2014-06-17

Lead Sponsor: Singapore General Hospital

Target Recruit Count: 6

Registration Number: NCT01333449

Locations: 🇸🇬
Singapore General Hospital, Singapore, Singapore

A Study of Oral Sapacitabine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia

Phase 3

Completed

Conditions: Acute Myeloid Leukemia

Interventions: Drug: Sapacitabine
Drug: Decitabine

First Posted Date: 2011-02-25

Last Posted Date: 2022-06-22

Lead Sponsor: Cyclacel Pharmaceuticals, Inc.

Target Recruit Count: 482

Registration Number: NCT01303796

Locations: 🇺🇸
Rush University Medical Center, Chicago, Illinois, United States
🇺🇸
The University of Chicago Medical Center, Chicago, Illinois, United States
🇺🇸
St. Francis Medical Group Oncology and Hematology Specialists, Indianapolis, Indiana, United States

and more 114 locations

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