Azacitidine

Generic Name: Azacitidine

Brand Names: Onureg, Vidaza, Azacitidine Accord, Azacitidine betapharm, Azacitidine Mylan, Azacitidine Kabi

Drug Type: Small Molecule

Chemical Formula: C_₈H_₁₂N_₄O_₅

CAS Number: 320-67-2

Unique Ingredient Identifier: M801H13NRU

Background: Azacitidine is a pyrimidine nucleoside analogue with anti-neoplastic activity. It differs from cytosine by the presence of nitrogen in the C5-position, key in its hypomethylating activity. Two main mechanisms of action have been proposed for azacitidine. One of them is the induction of cytotoxicity. As an analogue of cytidine, it is able to incorporate into ...

Indication: Azacitidine (for subcutaneous or intravenous use) is indicated for the treatment of adult patients with the following French-American-British (FAB) myelodysplastic syndrome (MDS) subtypes: refractory anemia (RA) or refractory anemia with ringed sideroblasts (RARS) (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemi...

Associated Conditions: Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia, Refractory Anemia, Refractory Anemia With Excess Blasts in Transformation, Refractory Anemia With Excess of Blasts (RAEB), Refractory Anemia With Ringed Sideroblasts, Newly diagnosed Juvenile Myelomonocytic Leukaemias (JMML)

Associated Therapies: -

Clinical Trials

VIDAZA-DLI Pre-emptive Azacitidine and Donor Lymphocyte Infusions Following Allogeneic Hematopoietic Stem Cell Transplantation for High Risk Acute Myeloid Leukemia and Myelodysplastic Syndrome

Phase 2

Completed

Conditions: Myelodysplastic Syndrome
Acute Myeloid Leukemia

First Posted Date: 2012-02-29

Last Posted Date: 2016-03-18

Lead Sponsor: Nantes University Hospital

Target Recruit Count: 30

Registration Number: NCT01541280

Locations: 🇫🇷
University Hospital of Nantes, Nantes, France

Azacitidine With or Without Lenalidomide or Vorinostat in Treating Patients With Higher-Risk Myelodysplastic Syndromes or Chronic Myelomonocytic Leukemia

Phase 2

Active, not recruiting

Conditions: Chronic Myelomonocytic Leukemia
Chronic Myelomonocytic Leukemia-1
Chronic Myelomonocytic Leukemia-2
Myelodysplastic Syndrome With Excess Blasts-1
Myelodysplastic Syndrome
Myelodysplastic Syndrome With Excess Blasts
Myelodysplastic Syndrome/Acute Myeloid Leukemia

Interventions: Drug: Azacitidine
Other: Laboratory Biomarker Analysis
Drug: Vorinostat
Drug: Lenalidomide

First Posted Date: 2012-02-01

Last Posted Date: 2024-11-13

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 282

Registration Number: NCT01522976

Locations: 🇺🇸
Rose Medical Center, Denver, Colorado, United States
🇺🇸
Western States Cancer Research NCORP, Denver, Colorado, United States
🇺🇸
Mercy Medical Center, Durango, Colorado, United States

and more 291 locations

Treatment of Patients With Myelodysplastic Syndrome or Acute Myelocytic Leukemia With an Impending Hematological Relapse With Azacitidine (Vidaza)

Phase 2

Completed

Conditions: Myelodysplastic Syndrome
Acute Myelocytic Leukemia

Interventions: Drug: Azacitidine

First Posted Date: 2011-10-31

Last Posted Date: 2021-11-15

Lead Sponsor: Technische Universität Dresden

Target Recruit Count: 93

Registration Number: NCT01462578

Locations: 🇩🇪
Klinikum Chemnitz (Küchwald), Chemnitz, Germany
🇩🇪
Universitätsklinikum Bonn, Bonn, Germany
🇩🇪
Universitätsklinikum Heidelberg, Medizinische Klinik, Abt. Innere Medizin V, Heidelberg, Germany

and more 8 locations

Azacitidine (AZA) in Minimal Residual Disease (MRD) Chronic Myeloid Leukemia (CML)

Phase 1

Completed

Conditions: Leukemia

Interventions: Drug: Azacitidine (AZA)
Drug: Tyrosine kinase inhibitor (TKI)
Drug: Azacitidine

First Posted Date: 2011-10-27

Last Posted Date: 2020-03-05

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 3

Registration Number: NCT01460498

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

Azacitidine + Lenalidomide Combo in the Elderly With Previously Treated AML & High-Risk MDS

Phase 2

Terminated

Conditions: Acute Myeloid Leukemia (AML)
Leukemia
Myelodysplastic Syndromes (MDS)

Interventions: Drug: Azacitidine
Drug: Lenalidomide

First Posted Date: 2011-09-28

Last Posted Date: 2018-01-03

Lead Sponsor: Stanford University

Target Recruit Count: 33

Registration Number: NCT01442714

Locations: 🇺🇸
Stanford University School of Medicine, Stanford, California, United States

Azacitidine After Chemotherapy and Donor Lymphocyte Infusion in Patients With Relapsed Acute Myeloid Leukemia or Myelodysplastic Syndrome Previously Treated With Donor Stem Cell Transplant

Phase 1

Completed

Conditions: Myelodysplastic Syndromes
Leukemia, Myeloid, Acute

Interventions: Drug: Pre-DLI Salvage Chemotherapy
Drug: Azacitidine
Biological: Donor Leukocyte Infusion (DLI)

First Posted Date: 2011-07-11

Last Posted Date: 2015-04-27

Lead Sponsor: Washington University School of Medicine

Target Recruit Count: 14

Registration Number: NCT01390311

Locations: 🇺🇸
Washington University School of Medicine, Saint Louis, Missouri, United States

Epigenetic Priming Using Azacitidine With Neoadjuvant Chemotherapy for Resectable Esophageal Cancer

Phase 1

Completed

Conditions: Esophageal Cancer
Malignant Neoplasm of Cardio-esophageal Junction of Stomach

Interventions: Drug: Azacitidine
Drug: Oxaliplatin
Drug: Epirubicin
Drug: Capecitabine

First Posted Date: 2011-07-01

Last Posted Date: 2018-12-12

Lead Sponsor: Weill Medical College of Cornell University

Target Recruit Count: 12

Registration Number: NCT01386346

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

A Study Being Conducted at Multiple Locations to Compare Safety and Efficacy of Three Different Regimens; (1) High-Dose Lenalidomide; (2) Lenalidomide + Azacitidine; or (3) Azacitidine in Subjects ≥ 65 Years With Newly-Diagnosed Acute Myeloid Leukemia

Phase 2

Completed

Conditions: Acute Myeloid Leukemia
Acute Myelogenous Leukemia

Interventions: Drug: Azacitidine
Other: Best Supportive Care (BSC)
Drug: Lenalidomide

First Posted Date: 2011-05-24

Last Posted Date: 2019-06-25

Lead Sponsor: Celgene

Target Recruit Count: 88

Registration Number: NCT01358734

Locations: 🇺🇸
(240) Cedars-Sinai Medical Center, Los Angeles, California, United States
🇺🇸
(160) The Western Pennsylvania Hospital- Cancer Institute, Pittsburgh, Pennsylvania, United States
🇺🇸
(200) Coastal Integrative Cancer Care, San Luis Obispo, California, United States

and more 27 locations

Azacitidine and Entinostat in Treating Patients With Advanced Breast Cancer

Phase 2

Active, not recruiting

Conditions: Recurrent Breast Carcinoma
Stage IIIC Breast Cancer AJCC v7
Triple-Negative Breast Carcinoma
Male Breast Carcinoma
Stage IV Breast Cancer AJCC v6 and v7

Interventions: Drug: Azacitidine
Drug: Entinostat
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study

First Posted Date: 2011-05-09

Last Posted Date: 2024-07-23

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 58

Registration Number: NCT01349959

Locations: 🇺🇸
Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, Maryland, United States
🇺🇸
Metro Minnesota Community Oncology Research Consortium, Saint Louis Park, Minnesota, United States
🇺🇸
USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States

and more 4 locations

Best Promising Drug Association With Azacitidine in Higher Risk Myelodysplastic Syndromes

Phase 2

Conditions: MDS

Interventions: Drug: Azacitidine associated with Lenalidomide
Drug: Azacitidine associated with Valproic acid
Drug: Azacitidine associated with Idarubicine
Drug: Azacitidine

First Posted Date: 2011-04-27

Last Posted Date: 2019-02-19

Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Target Recruit Count: 320

Registration Number: NCT01342692

Locations: 🇫🇷
Avicenne hospital, Bobigny, France

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