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

Cord Blood Natural Killer (NK) Cells in Leukemia/Lymphoma

Phase 1

Completed

Conditions: Leukemia

Interventions: Drug: Lenalidomide
Drug: Rituximab
Drug: Fludarabine
Drug: Cyclophosphamide
Drug: Cytarabine
Procedure: NK Cells

First Posted Date: 2014-10-31

Last Posted Date: 2023-06-07

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 8

Registration Number: NCT02280525

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

Azacytidine Plus FLAG for Relapsed or Refractory AML

Phase 2

Conditions: Acute Myeloid Leukemia

Interventions: Drug: Azacytidine
Drug: Fludarabine
Drug: Cytarabine
Drug: Filgrastim

First Posted Date: 2014-10-27

Last Posted Date: 2015-01-06

Lead Sponsor: King Fahad Medical City

Target Recruit Count: 37

Registration Number: NCT02275663

Locations: 🇸🇦
King Fahad Medical City, Riyadh, Saudi Arabia

Lenalidomide in Combination With Microtransplantation as Post-remission Therapy in AML

Phase 1

Terminated

Conditions: Acute Myeloid Leukemia (AML)
Acute Myelocytic Leukemia
Acute Non-Lymphocytic Leukemia
Acute Myelogenous Leukemia
Acute Granulocytic Leukemia

Interventions: Drug: Lenalidomide
Genetic: HLA-mismatched stem-cell Microtransplantation
Drug: Cytarabine

First Posted Date: 2014-10-02

Last Posted Date: 2017-08-18

Lead Sponsor: Massachusetts General Hospital

Target Recruit Count: 8

Registration Number: NCT02255162

Locations: 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States

A Phase II Study of Selinexor Plus Cytarabine and Idarubicin in Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML)

Phase 2

Completed

Conditions: Acute Myeloid Leukemia (Relapsed/Refractory)

Interventions: Drug: Selinexor
Drug: Idarubicin
Drug: Cytarabine

First Posted Date: 2014-09-25

Last Posted Date: 2021-08-25

Lead Sponsor: GSO Global Clinical Research BV

Target Recruit Count: 42

Registration Number: NCT02249091

Locations: 🇩🇪
Universitätsklinikum Frankfurt, Frankfurt am Main, Hessen, Germany
🇩🇪
Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany
🇩🇪
Medizinische Hochschule Hannover, Hannover, Niedersachsen, Germany

A Study of ASP2215 in Combination With Induction and Consolidation Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia

Phase 1

Completed

Conditions: Acute Myeloid Leukemia

Interventions: Drug: Gilteritinib
Drug: Idarubicin
Drug: Cytarabine
Drug: Daunorubicin

First Posted Date: 2014-09-10

Last Posted Date: 2024-11-05

Lead Sponsor: Astellas Pharma Global Development, Inc.

Target Recruit Count: 80

Registration Number: NCT02236013

Locations: 🇺🇸
Site US10003, Los Angeles, California, United States
🇺🇸
Site US10013, New Haven, Connecticut, United States
🇺🇸
Site US10004, Chicago, Illinois, United States

and more 7 locations

Randomised Controlled Phase-2 Trial to Determine the Efficacy of Adoptive Immunotherapy With NK Cells in High-risk AML

Phase 2

Terminated

Conditions: Acute Myeloid Leukemia

Interventions: Biological: NK cells
Drug: Cytarabine

First Posted Date: 2014-09-01

Last Posted Date: 2021-08-16

Lead Sponsor: Technische Universität Dresden

Target Recruit Count: 1

Registration Number: NCT02229266

Locations: 🇩🇪
Universitätsklinikum Dresden, Dresden, Germany
🇩🇪
Klinikum Bayreuth, Bayreuth, Germany
🇩🇪
Klinikum Chemnitz, Chemnitz, Germany

Phase I Study of MLN 9708 in Addition to Chemotherapy for the Treatment of Acute Lymphoblastic Leukemia in Older Adults

Phase 1

Completed

Conditions: Acute Lymphoblastic Leukemia
Lymphoblastic Lymphoma
B-cell Adult Acute Lymphoblastic Leukemia
T-cell Adult Acute Lymphoblastic Leukemia

Interventions: Drug: MLN 9708
Drug: Vincristine
Drug: Cytarabine
Drug: Doxorubicin
Drug: Mercaptopurine
Drug: Cyclophosphamide
Drug: Methotrexate

First Posted Date: 2014-08-29

Last Posted Date: 2019-11-26

Lead Sponsor: Massachusetts General Hospital

Target Recruit Count: 19

Registration Number: NCT02228772

Locations: 🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

Selinexor With Fludarabine and Cytarabine for Treatment of Refractory or Relapsed Leukemia or Myelodysplastic Syndrome

Phase 1

Completed

Conditions: Acute Myeloid Leukemia (AML)
Acute Lymphoblastic Leukemia (ALL)
Myelodysplastic Syndrome (MDS)
Mixed Phenotype Acute Leukemia (MPAL)

Interventions: Drug: Selinexor
Drug: Fludarabine
Drug: Cytarabine
Drug: methotrexate/hydrocortisone/cytarabine

First Posted Date: 2014-08-08

Last Posted Date: 2020-03-26

Lead Sponsor: St. Jude Children's Research Hospital

Target Recruit Count: 19

Registration Number: NCT02212561

Locations: 🇺🇸
St. Jude Children's Research Hospital, Memphis, Tennessee, United States
🇺🇸
Cook Children's Medical Center, Fort Worth, Texas, United States
🇺🇸
Phoenix Children's Hospital, Phoenix, Arizona, United States

and more 3 locations

LCH-IV, International Collaborative Treatment Protocol for Children and Adolescents With Langerhans Cell Histiocytosis

Phase 2

Recruiting

Conditions: Langerhans Cell Histiocytosis

Interventions: Procedure: hematopoietic stem cell transplantation (RIC-HSCT)
Drug: Prednisone
Drug: 2-chlorodeoxyadenosine
Drug: Vinblastine
Biological: Intravenous immunoglobulin
Drug: mercaptopurine
Drug: INDOMETHACIN
Drug: Methotrexate
Drug: Cytosine Arabinoside

First Posted Date: 2014-07-31

Last Posted Date: 2023-03-23

Lead Sponsor: North American Consortium for Histiocytosis

Target Recruit Count: 1400

Registration Number: NCT02205762

Locations: 🇺🇸
Children's Medical Center Dallas, UT Southwestern, Dallas, Texas, United States
🇺🇸
Children's Hospital of Los Angeles, Los Angeles, California, United States
🇺🇸
Hackensack University Medical Center, Hackensack, New Jersey, United States

and more 35 locations

Phase 1 Study of Ibrutinib and Immuno-Chemotherapy Using Temozolomide, Etoposide, Doxil, Dexamethasone, Ibrutinib,Rituximab (TEDDI-R) in Primary CNS Lymphoma

Phase 1

Recruiting

Conditions: Primary Central Nervous System Lymphoma

Interventions: Drug: Isavuconazole
Drug: TEDDI
Biological: Rituximab
Drug: Cytarabine
Drug: TEDD
Drug: Ibrutinib (Arms 2, 3 and 4)
Drug: Methotrexate
Drug: Ibrutinib (Arm 1 - Closed with Amendment G)
Drug: Ibrutinib (Arm 4)

First Posted Date: 2014-07-30

Last Posted Date: 2025-01-07

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 93

Registration Number: NCT02203526

Locations: 🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States

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