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Cytarabine

Generic Name
Cytarabine
Brand Names
Cytosar, Vyxeos
Drug Type
Small Molecule
Chemical Formula
C9H13N3O5
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
-

Azacitidine in Combination With Mitoxantrone, Etoposide Phosphate, and Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

Phase 1
Completed
Conditions
Refractory Acute Myeloid Leukemia
Recurrent Adult Acute Myeloid Leukemia
Interventions
Drug: Azacitidine
Drug: Cytarabine
Drug: Etoposide Phosphate
Other: Laboratory Biomarker Analysis
Drug: Mitoxantrone Hydrochloride
Other: Pharmacological Study
First Posted Date
2010-11-29
Last Posted Date
2017-09-21
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
24
Registration Number
NCT01249430
Locations
🇺🇸

Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States

Lenalidomide and Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

Phase 1
Completed
Conditions
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
Recurrent Adult Acute Myeloid Leukemia
Adult Acute Myeloid Leukemia With Del(5q)
Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
Interventions
First Posted Date
2010-11-23
Last Posted Date
2020-09-24
Lead Sponsor
Roswell Park Cancer Institute
Target Recruit Count
32
Registration Number
NCT01246622
Locations
🇺🇸

Roswell Park Cancer Institute, Buffalo, New York, United States

Study of Low-Dose Cytarabine and Etoposide With or Without All-Trans Retinoic Acid in Older Patients Not Eligible for Intensive Chemotherapy With Acute Myeloid Leukemia and NPM1 Mutation

Phase 3
Completed
Conditions
Acute Myeloid Leukemia (AML)
Interventions
Drug: Cytarabine
Drug: Etoposide
Drug: All-trans retinoic acid (ATRA)
First Posted Date
2010-11-10
Last Posted Date
2018-08-01
Lead Sponsor
University of Ulm
Target Recruit Count
144
Registration Number
NCT01237808
Locations
🇩🇪

Ubbo-Emmius Klinik Aurich, Aurich, Germany

🇩🇪

Charité Universitätsmedizin Berlin, Berlin, Germany

🇩🇪

Medizinische Universitätsklinik, Freiburg, Germany

and more 30 locations

Combination Chemotherapy and Dasatinib in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia

Phase 2
Completed
Conditions
Adult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11
Therapy-Related Acute Myeloid Leukemia
Acute Myeloid Leukemia
Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11
Adult Acute Myeloid Leukemia With t(8;21); (q22; q22.1); RUNX1-RUNX1T1
Core Binding Factor Acute Myeloid Leukemia
Secondary Acute Myeloid Leukemia
Interventions
First Posted Date
2010-11-10
Last Posted Date
2023-03-01
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
61
Registration Number
NCT01238211
Locations
🇺🇸

University of Illinois, Chicago, Illinois, United States

🇺🇸

University of Maryland/Greenebaum Cancer Center, Baltimore, Maryland, United States

🇺🇸

Heartland Cancer Research NCORP, Decatur, Illinois, United States

and more 62 locations

Clofarabine or High-Dose Cytarabine and Pegaspargase in Children with ALL

First Posted Date
2010-10-26
Last Posted Date
2024-12-11
Lead Sponsor
Universitätsklinikum Hamburg-Eppendorf
Target Recruit Count
745
Registration Number
NCT01228331
Locations
🇩🇪

Universitaetsklinikum Duesseldorf, Duesseldorf, Germany

🇩🇪

University Medical Center Hamburg - Eppendorf, Hamburg, Germany

🇩🇪

Johannes Gutenberg University, Mainz, Germany

and more 11 locations

Clofarabine and Low-dose Cytarabine Followed by Consolidation Therapy in AML Patients Age Greater Than or Equal to 60 Years

Phase 2
Terminated
Conditions
Acute Myelogenous Leukemia
Interventions
First Posted Date
2010-09-01
Last Posted Date
2014-04-07
Lead Sponsor
PETHEMA Foundation
Target Recruit Count
75
Registration Number
NCT01193400
Locations
🇪🇸

Hospital de la Santa Creu i Sant Pau., Barcelona, Spain

🇪🇸

Hospital Durán i Reynals (Bellvitge)., Barcelona, Spain

🇪🇸

Hospital General de Alicante., Alicante, Spain

and more 12 locations

Cytarabine (Ara-C) in Children With Acute Promyelocytic Leukemia (APL)

Phase 4
Completed
Conditions
Leukemia
Interventions
First Posted Date
2010-08-31
Last Posted Date
2021-08-10
Lead Sponsor
Xiaofan Zhu
Target Recruit Count
65
Registration Number
NCT01191541
Locations
🇨🇳

Department of Pediatrics, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Tianjin, PR China, Tianjin, China

🇨🇳

Institute of Hematology & Blood Diseases Hospital, Tianjin, Tianjin, China

Risk-Adapted Chemotherapy in Treating Younger Patients With Newly Diagnosed Standard-Risk Acute Lymphoblastic Leukemia or Localized B-Lineage Lymphoblastic Lymphoma

Phase 3
Active, not recruiting
Conditions
Ann Arbor Stage I B Lymphoblastic Lymphoma
Childhood B Acute Lymphoblastic Leukemia
Acute Lymphoblastic Leukemia
Adult B Lymphoblastic Lymphoma
Childhood B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1
Down Syndrome
Hypodiploid B Acute Lymphoblastic Leukemia
Philadelphia Chromosome Positive
Ann Arbor Stage II B Lymphoblastic Lymphoma
Childhood B Lymphoblastic Lymphoma
Interventions
First Posted Date
2010-08-30
Last Posted Date
2024-02-08
Lead Sponsor
Children's Oncology Group
Target Recruit Count
9350
Registration Number
NCT01190930
Locations
🇺🇸

Valley Children's Hospital, Madera, California, United States

🇺🇸

University of Maryland/Greenebaum Cancer Center, Baltimore, Maryland, United States

🇺🇸

UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, California, United States

and more 241 locations
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