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

Decitabine, Vorinostat, and Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome

Phase 1

Completed

Conditions: Recurrent Adult Acute Myeloid Leukemia
Secondary Acute Myeloid Leukemia
Untreated Adult Acute Myeloid Leukemia
Previously Treated Myelodysplastic Syndrome
Refractory Acute Myeloid Leukemia
Therapy-Related Acute Myeloid Leukemia

Interventions: Drug: Cytarabine
Drug: Decitabine
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study
Drug: Vorinostat

First Posted Date: 2010-05-26

Last Posted Date: 2017-08-02

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 17

Registration Number: NCT01130506

Locations: 🇺🇸
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

Bortezomib, Mitoxantrone, Etoposide, and Cytarabine in Relapsed or Refractory Acute Myeloid Leukemia

Phase 1

Completed

Conditions: Adult Acute Minimally Differentiated Myeloid Leukemia (M0)
Adult Acute Megakaryoblastic Leukemia (M7)
Adult Acute Monoblastic Leukemia (M5a)
Adult Acute Monocytic Leukemia (M5b)
Adult Acute Myelomonocytic Leukemia (M4)
Adult Pure Erythroid Leukemia (M6b)
Adult Acute Myeloblastic Leukemia Without Maturation (M1)
Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
Recurrent Adult Acute Myeloid Leukemia

Interventions: Drug: bortezomib
Drug: mitoxantrone hydrochloride
Drug: etoposide
Drug: cytarabine
Other: flow cytometry

First Posted Date: 2010-05-20

Last Posted Date: 2015-08-13

Lead Sponsor: Case Comprehensive Cancer Center

Target Recruit Count: 3

Registration Number: NCT01127009

Locations: 🇺🇸
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center, Cleveland, Ohio, United States

International Collaborative Treatment Protocol For Children And Adolescents With Acute Lymphoblastic Leukemia

Phase 3

Completed

Conditions: Leukemia

Interventions: Drug: PEG-L-asparaginase
Drug: cyclophosphamide
Drug: cytarabine
Drug: daunorubicin hydrochloride
Drug: dexamethasone
Drug: doxorubicin hydrochloride
Drug: etoposide
Drug: mercaptopurine
Drug: ifosfamide
Drug: methotrexate
Drug: vincristine sulfate
Drug: prednisone
Radiation: Radiation Therapy
Drug: thioguanine
Drug: vindesine
Drug: daunoxome
Drug: fludarabine

First Posted Date: 2010-05-05

Last Posted Date: 2022-05-24

Lead Sponsor: University Hospital Schleswig-Holstein

Target Recruit Count: 6136

Registration Number: NCT01117441

Locations: 🇦🇹
A.oe. Landeskrankenhaus Klagenfurt, Abt. für Kinder- und Jugendheilkunde, Klagenfurt, Austria
🇨🇿
University Hospital Brno, Department of Pediatric Oncology, Brno, Czechia
🇩🇪
Klinikum Berlin-Buch II. Kinderklinik, Bereich Onkologie/Allg. Pädiatrie, Berlin, Germany

and more 134 locations

Clofarabine, Cytarabine, and Filgrastim in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia, Advanced Myelodysplastic Syndrome, and/or Advanced Myeloproliferative Neoplasm

Phase 2

Completed

Conditions: Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Adult Acute Myeloid Leukemia With Del(5q)
Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
Chronic Myelomonocytic Leukemia
de Novo Myelodysplastic Syndromes
Refractory Anemia With Excess Blasts
Untreated Adult Acute Myeloid Leukemia

Interventions: Biological: filgrastim
Drug: clofarabine
Drug: cytarabine

First Posted Date: 2010-04-12

Last Posted Date: 2017-10-19

Lead Sponsor: University of Washington

Target Recruit Count: 50

Registration Number: NCT01101880

Locations: 🇺🇸
City of Hope Medical Center, Duarte, California, United States
🇺🇸
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium, Seattle, Washington, United States
🇺🇸
Stanford University, Stanford, California, United States

Standard Chemotherapy With or Without Nelarabine or Rituximab in Treating Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

Phase 3

Active, not recruiting

Conditions: Leukemia
Oral Complications
Mucositis

Interventions: Biological: rituximab
Biological: palifermin
Drug: cyclophosphamide
Procedure: allogeneic hematopoietic stem cell transplantation
Drug: cytarabine
Drug: daunorubicin hydrochloride
Radiation: total-body irradiation
Drug: etoposide
Drug: fludarabine phosphate
Drug: imatinib mesylate
Drug: melphalan
Drug: mercaptopurine
Drug: methotrexate
Drug: nelarabine
Drug: pegaspargase
Drug: vincristine sulfate

First Posted Date: 2010-03-12

Last Posted Date: 2024-05-10

Lead Sponsor: University College, London

Target Recruit Count: 1033

Registration Number: NCT01085617

ALFA-0703 Study in Older Patients With Acute Myeloblastic Leukemia (AML)

Phase 3

Withdrawn

Conditions: Acute Myeloid Leukemia

Interventions: Drug: Vesanoid (ATRA)
Drug: AZACITIDINE (VIDAZA)
Drug: CYTARABINE

First Posted Date: 2010-02-11

Last Posted Date: 2015-12-30

Lead Sponsor: Acute Leukemia French Association

Registration Number: NCT01067274

Locations: 🇫🇷
CHU, Rouen, France
🇫🇷
Hopital Percy, Clamart, France
🇫🇷
Centre Antoine Lacassagne, Nice, France

and more 15 locations

Lenalidomide Therapy After Chemotherapy & Stem Cell Transplant in Treating Chemotherapy Resistan Non-Hodgkin Lymphoma

Phase 1

Completed

Conditions: Recurrent Non-Hodgkin Lymphoma
Anaplastic Large Cell Lymphoma, ALK-Negative
Recurrent Anaplastic Large Cell Lymphoma
Recurrent Transformed Non-Hodgkin Lymphoma
Recurrent Mantle Cell Lymphoma
Recurrent Mature T- and NK-Cell Non-Hodgkin Lymphoma

Interventions: Procedure: Autologous Hematopoietic Stem Cell Transplantation
Drug: Carmustine
Drug: Cytarabine
Drug: Etoposide
Drug: Lenalidomide
Drug: Melphalan
Biological: Rituximab

First Posted Date: 2009-12-18

Last Posted Date: 2023-10-10

Lead Sponsor: University of Nebraska

Target Recruit Count: 74

Registration Number: NCT01035463

Locations: 🇺🇸
University of Kansas Hospital-Westwood Cancer Center, Westwood, Kansas, United States
🇺🇸
University of Nebraska Medical Center, Omaha, Nebraska, United States
🇺🇸
Seidman Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center, Cleveland, Ohio, United States

A Study of AS1411 Combined With Cytarabine in the Treatment of Patients With Primary Refractory or Relapsed Acute Myeloid Leukemia

Phase 2

Terminated

Conditions: Acute Myeloid Leukemia

Interventions: Drug: AS1411
Drug: Cytarabine

First Posted Date: 2009-12-17

Last Posted Date: 2011-02-02

Lead Sponsor: Antisoma Research

Target Recruit Count: 90

Registration Number: NCT01034410

Locations: 🇨🇳
National Taiwan University Hospital, Taipei, Taiwan
🇦🇺
Westmead Hospital, Westmead, New South Wales, Australia
🇺🇸
Medical University of South Carolina, Charleston, South Carolina, United States

and more 11 locations

Clofarabine, Cytarabine, and Filgrastim Followed by Infusion of Non-HLA Matched Ex Vivo Expanded Cord Blood Progenitors in Treating Patients With Acute Myeloid Leukemia

Phase 1

Completed

Conditions: Adult Acute Minimally Differentiated Myeloid Leukemia (M0)
Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
Adult Acute Monoblastic Leukemia (M5a)
Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
Recurrent Adult Acute Myeloid Leukemia
Adult Acute Megakaryoblastic Leukemia (M7)
Adult Acute Monocytic Leukemia (M5b)
Adult Acute Myeloblastic Leukemia With Maturation (M2)
Adult Acute Myeloblastic Leukemia Without Maturation (M1)

Interventions: Drug: cytarabine
Drug: clofarabine
Drug: filgrastim
Biological: Ex-vivo expanded cord blood progenitor cell infusion
Other: laboratory biomarker analysis