Cytarabine

Generic Name: Cytarabine

Brand Names: Cytosar, Vyxeos

Drug Type: Small Molecule

Chemical Formula: C_₉H_₁₃N_₃O_₅

CAS Number: 147-94-4

Unique Ingredient Identifier: 04079A1RDZ

Background: A pyrimidine nucleoside analog that is used mainly in the treatment of leukemia, especially acute non-lymphoblastic leukemia. Cytarabine is an antimetabolite antineoplastic agent that inhibits the synthesis of DNA. Its actions are specific for the S phase of the cell cycle. It also has antiviral and immunosuppressant properties. (From Martindale, The Extra Pharmacopoeia, 30th ed, p472)

Indication: For the treatment of acute non-lymphocytic leukemia, acute lymphocytic leukemia and blast phase of chronic myelocytic leukemia.

Cytarabine is indicated in combination with daunorubicin for the treatment of newly-diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC) in adults and pediatric patients 1 year and older.

Associated Conditions: Acute Lymphoblastic Leukemia (ALL), Acute Myeloid Leukemia, Acute Myeloid Leukemia With Myelodysplasia-Related Changes, Acute Promyelocytic Leukemia, Meningeal leukemia, Metastatic Malignant Neoplasm to the Leptomeninges, Non-Hodgkin's Lymphoma (NHL), Treatment-Related Acute Myeloid Leukemia, Blast phase Chronic myeloid leukemia

Associated Therapies: -

Clinical Trials

Treatment of Sickle Cell Anemia With Stem Cell Transplant

Not Applicable

Terminated

Conditions: Sickle Cell Anemia
Sickle Cell-hemoglobin C Disease
Sickle Cell-β0-thalassemia

Interventions: Drug: Fludarabine
Drug: Cytarabine
Device: Cellular Infusions
Radiation: Total Body Irradiation
Drug: Cyclophosphamide
Drug: Bortezomib
Drug: Rituximab
Procedure: Plasmapheresis

First Posted Date: 2011-05-09

Last Posted Date: 2016-11-29

Lead Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University

Target Recruit Count: 2

Registration Number: NCT01350232

Locations: 🇺🇸
Thomas Jefferson University, Philadelphia, Pennsylvania, United States

Alvocidib, Cytarabine, and Mitoxantrone Hydrochloride or Cytarabine and Daunorubicin Hydrochloride in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia

Phase 2

Completed

Conditions: Adult Acute Minimally Differentiated Myeloid Leukemia (M0)
Adult Acute Monoblastic Leukemia (M5a)
Adult Erythroleukemia (M6a)
Adult Pure Erythroid Leukemia (M6b)
Secondary Acute Myeloid Leukemia
Untreated Adult Acute Myeloid Leukemia
Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome
Adult Acute Monocytic Leukemia (M5b)
Adult Acute Myeloblastic Leukemia With Maturation (M2)
Adult Acute Myeloblastic Leukemia Without Maturation (M1)

Interventions: Drug: daunorubicin hydrochloride
Drug: alvocidib
Drug: mitoxantrone hydrochloride
Drug: cytarabine

First Posted Date: 2011-05-09

Last Posted Date: 2017-07-31

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 172

Registration Number: NCT01349972

Locations: 🇺🇸
Blood and Marrow Transplant Group of Georgia, Atlanta, Georgia, United States
🇺🇸
Mayo Clinic Scottsdale-Phoenix, Scottsdale, Arizona, United States
🇺🇸
Johns Hopkins University/Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, United States

and more 8 locations

A Randomized Phase III Study of Intensive Consolidation With High Dose Cytosine Arabinoside in Acute Myelogenous Leukemia (AML-8B)

Phase 3

Completed

Conditions: Leukemia

First Posted Date: 2011-03-28

Last Posted Date: 2012-07-16

Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

Target Recruit Count: 160

Registration Number: NCT01324063

A Study Of Panobinostat In Children With Refractory Hematologic Malignancies

Phase 1

Completed

Conditions: Myelogenous Leukemia, Acute, Childhood
Hodgkin's Disease
Non-Hodgkin's Lymphoma
Lymphoblastic Leukemia, Acute, Childhood

Interventions: Drug: Panobinostat
Drug: Cytarabine

First Posted Date: 2011-03-23

Last Posted Date: 2015-11-24

Lead Sponsor: Therapeutic Advances in Childhood Leukemia Consortium

Target Recruit Count: 30

Registration Number: NCT01321346

Locations: 🇺🇸
UCSF School of Medicine, San Francisco, California, United States
🇺🇸
Childrens Hospital Los Angeles, Los Angeles, California, United States
🇺🇸
University of Miami Cancer Center, Miami, Florida, United States

and more 17 locations

Hyper-CVAD With Liposomal Vincristine in Acute Lymphoblastic Leukemia

Phase 2

Completed

Conditions: Leukemia

Interventions: Drug: Rituximab
Drug: Imatinib
Drug: VSLI
Drug: Cyclophosphamide
Drug: Doxorubicin
Drug: Solu-Medrol
Drug: Mesna
Drug: Methotrexate
Drug: Ara-C
Drug: G-CSF
Drug: Pegfilgrastim
Drug: Dexamethasone

First Posted Date: 2011-03-22

Last Posted Date: 2022-09-27

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 31

Registration Number: NCT01319981

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

PETHEMA-LMA10: Treatment of Acute Myeloblastic Leukemia (AML) in Patients Less Than or Equal to 65 Years

Not Applicable

Conditions: Acute Myeloblastic Leukemia

First Posted Date: 2011-02-15

Last Posted Date: 2021-03-23

Lead Sponsor: PETHEMA Foundation

Target Recruit Count: 200

Registration Number: NCT01296178

Locations: 🇪🇸
Hospital La Fe, Valencia, Spain

Clofarabine, Idarubicin, and Cytarabine (CIA) Versus Fludarabine, Idarubicin, and Cytarabine (FLAI) in Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome

Phase 1

Completed

Conditions: Leukemia

Interventions: Drug: Clofarabine
Drug: Idarubicin
Drug: Cytarabine
Drug: Fludarabine

First Posted Date: 2011-02-03

Last Posted Date: 2020-02-24

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 282

Registration Number: NCT01289457

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

Omacetaxine and Low Dose Cytarabine in Older Patients With Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome (MDS)

Phase 2

Completed

Conditions: Leukemia

Interventions: Drug: Omacetaxine
Drug: Cytarabine

First Posted Date: 2011-01-07

Last Posted Date: 2018-05-30

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 36

Registration Number: NCT01272245

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

Dasatinib Followed by Stem Cell Transplant in Treating Older Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

Phase 2

Completed

Conditions: Acute Lymphoblastic Leukemia
Adult B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1

Interventions: Biological: Alemtuzumab
Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
Procedure: Autologous Hematopoietic Stem Cell Transplantation
Drug: Cyclophosphamide
Drug: Cytarabine
Drug: Dasatinib
Drug: Daunorubicin Hydrochloride
Drug: Dexamethasone
Drug: Etoposide Phosphate
Biological: Filgrastim
Drug: Fludarabine Phosphate
Procedure: In Vitro-Treated Peripheral Blood Stem Cell Transplantation
Other: Laboratory Biomarker Analysis
Drug: Leucovorin Calcium
Drug: Melphalan
Drug: Mercaptopurine
Drug: Methotrexate
Biological: Pegfilgrastim
Other: Pharmacological Study
Drug: Tacrolimus
Drug: Vincristine Sulfate

First Posted Date: 2010-12-08

Last Posted Date: 2023-04-04

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 66

Registration Number: NCT01256398

Locations: 🇺🇸
Rocky Mountain Cancer Centers-Longmont, Longmont, Colorado, United States
🇺🇸
Fort Wayne Medical Oncology and Hematology Inc-Parkview, Fort Wayne, Indiana, United States
🇺🇸
Longmont United Hospital, Longmont, Colorado, United States

and more 98 locations

Sorafenib Tosylate and Chemotherapy in Treating Older Patients With Acute Myeloid Leukemia

Phase 2

Completed

Conditions: Acute Myeloid Leukemia With Inv(16)(p13.1q22) or t(16;16)(p13.1;q22); CBFB-MYH11
Acute Promyelocytic Leukemia With PML-RARA
Acute Myeloid Leukemia With t(8;21); (q22; q22.1); RUNX1-RUNX1T1
Therapy-Related Acute Myeloid Leukemia
Acute Myeloid Leukemia With FLT3/ITD Mutation
FLT3 Gene Mutation

Interventions: Procedure: Biopsy
Procedure: Bone Marrow Aspiration
Drug: Cytarabine
Drug: Daunorubicin Hydrochloride
Other: Laboratory Biomarker Analysis
Other: Quality-of-Life Assessment
Other: Questionnaire Administration
Drug: Sorafenib Tosylate

First Posted Date: 2010-12-03

Last Posted Date: 2022-08-04

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 54

Registration Number: NCT01253070

Locations: 🇺🇸
Cooper Hospital University Medical Center, Camden, New Jersey, United States
🇺🇸
University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States
🇺🇸
Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States

and more 40 locations

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