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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
-

Pethema LAL-RI/2008: Treatment for Patients With Standard Risk Acute Lymphoblastic Leukemia

Phase 4
Completed
Conditions
Acute Lymphobkastic Leukemia
Interventions
Drug: Vincristine
Drug: Daunorubicin
Drug: Prednisone
Drug: L-asparaginase
Drug: Ciclophosphamide
Drug: Metotrexate
Drug: ARA-C
Drug: Hidrocortisone
Drug: Mercaptopurine
Drug: VP-16
Drug: Dexametasone
First Posted Date
2014-01-15
Last Posted Date
2020-03-05
Lead Sponsor
PETHEMA Foundation
Target Recruit Count
107
Registration Number
NCT02036489
Locations
🇪🇸

Hospital Germans Trias i Pujol, Barcelona, Spain

Pomalidomide After Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome

Phase 1
Completed
Conditions
Chronic Myelomonocytic Leukemia-2
Acute Myeloid Leukemia
High Risk Myelodysplastic Syndrome
Myeloproliferative Neoplasm
Interventions
First Posted Date
2014-01-08
Last Posted Date
2020-10-14
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
50
Registration Number
NCT02029950
Locations
🇺🇸

Yale University, New Haven, Connecticut, United States

🇺🇸

UNC Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, United States

🇺🇸

Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, Maryland, United States

Omacetaxine Mepesuccinate, Cytarabine, and Decitabine in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia

Phase 2
Terminated
Conditions
Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome
Untreated Adult Acute Myeloid Leukemia
Adult Acute Megakaryoblastic Leukemia (M7)
Adult Acute Minimally Differentiated Myeloid Leukemia (M0)
Adult Acute Monoblastic Leukemia (M5a)
Adult Acute Monocytic Leukemia (M5b)
Adult Acute Myeloblastic Leukemia With Maturation (M2)
Adult Acute Myeloblastic Leukemia Without Maturation (M1)
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Adult Acute Myeloid Leukemia With Del(5q)
Interventions
First Posted Date
2014-01-07
Last Posted Date
2016-05-09
Lead Sponsor
Roswell Park Cancer Institute
Target Recruit Count
2
Registration Number
NCT02029417
Locations
🇺🇸

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

AML1-ETO Acute Myeloid Leukemia With Fludarabine and Cytarabine Chemotherapy

Phase 4
Conditions
Acute Myeloid Leukemia
AML1-ETO Fusion Protein Expression
Interventions
First Posted Date
2013-12-31
Last Posted Date
2013-12-31
Lead Sponsor
Changhai Hospital
Target Recruit Count
62
Registration Number
NCT02024308
Locations
🇨🇳

Department of Hematology, Changhai Hospital, Shanghai, China

Randomized Phase III Study of Intensive Chemotherapy With or Without Dasatinib (Sprycel™)

Phase 3
Completed
Conditions
Acute Myeloid Leukemia (AML)
Interventions
First Posted Date
2013-12-17
Last Posted Date
2024-02-23
Lead Sponsor
University of Ulm
Target Recruit Count
204
Registration Number
NCT02013648
Locations
🇦🇹

Hanuschkrankenhaus, Wien, Austria

🇦🇹

Krankenhaus der Barmherzigen Schwestern, Linz, Austria

🇦🇹

Universitätsklinik der PMU, Salzburg, Austria

and more 51 locations

Combination Chemotherapy With or Without Blinatumomab in Treating Patients With Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic Leukemia

Phase 3
Active, not recruiting
Conditions
Acute Lymphoblastic Leukemia
B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative
Interventions
Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
Procedure: Biospecimen Collection
Biological: Blinatumomab
Procedure: Bone Marrow Aspiration
Procedure: Bone Marrow Biopsy
Drug: Cyclophosphamide
Drug: Cytarabine
Drug: Daunorubicin
Drug: Daunorubicin Hydrochloride
Drug: Dexamethasone
Drug: Etoposide
Drug: Leucovorin Calcium
Procedure: Lumbar Puncture
Drug: Mercaptopurine
Drug: Methotrexate
Drug: Pegaspargase
Drug: Prednisone
Biological: Rituximab
Drug: Vincristine
Drug: Vincristine Sulfate
Procedure: X-Ray Imaging
First Posted Date
2013-12-06
Last Posted Date
2024-12-05
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
488
Registration Number
NCT02003222
Locations
🇺🇸

Banner North Colorado Medical Center, Greeley, Colorado, United States

🇺🇸

Good Samaritan Hospital - Cancer Centers of Colorado, Lafayette, Colorado, United States

🇺🇸

Banner McKee Medical Center, Loveland, Colorado, United States

and more 545 locations

Pilot Study Efficacy and Tolerance Fish Oil Emulsion Daunorubicin and Cytarabine Treatment of AML Younger Patients

Phase 2
Completed
Conditions
Acute Myeloid Leukemia (AML)
Interventions
First Posted Date
2013-12-03
Last Posted Date
2018-04-27
Lead Sponsor
French Innovative Leukemia Organisation
Target Recruit Count
30
Registration Number
NCT01999413
Locations
🇫🇷

Emmanuel GYAN, Tours, France

Brentuximab Vedotin or Crizotinib and Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage II-IV Anaplastic Large Cell Lymphoma

Phase 2
Completed
Conditions
Anaplastic Large Cell Lymphoma, ALK-Positive
Ann Arbor Stage III Noncutaneous Childhood Anaplastic Large Cell Lymphoma
Ann Arbor Stage II Noncutaneous Childhood Anaplastic Large Cell Lymphoma
Ann Arbor Stage IV Noncutaneous Childhood Anaplastic Large Cell Lymphoma
Interventions
First Posted Date
2013-11-08
Last Posted Date
2024-04-30
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
137
Registration Number
NCT01979536
Locations
🇺🇸

Nationwide Children's Hospital, Columbus, Ohio, United States

🇺🇸

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

🇺🇸

Naval Medical Center - Portsmouth, Portsmouth, Virginia, United States

and more 151 locations

Study of Melphalan HCl for Injection (Propylene Glycol-free), Carmustine, Etoposide, Cytarabine (BEAM Regimen) and Autologous Stem Cell Transplantation for Lymphoma

Phase 2
Completed
Conditions
Hodgkin Disease
Lymphoma, Non-Hodgkin
Interventions
First Posted Date
2013-10-25
Last Posted Date
2018-02-13
Lead Sponsor
Washington University School of Medicine
Target Recruit Count
50
Registration Number
NCT01969435
Locations
🇺🇸

Washington University School of Medicine, Saint Louis, Missouri, United States

Phase II Clofarabine and Cytarabine for Newly Diagnosed Acute Myeloid Leukemia

Phase 2
Terminated
Conditions
Acute Myeloid Leukemia
Interventions
First Posted Date
2013-10-10
Last Posted Date
2016-08-02
Lead Sponsor
University of Pittsburgh
Target Recruit Count
2
Registration Number
NCT01960387
Locations
🇺🇸

UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, United States

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