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

International Randomised Phase III Clinical Trial in Children With Acute Myeloid Leukaemia

Phase 3

Recruiting

Conditions: Acute Myeloid Leukaemia

Interventions: Drug: Mitoxantrone
Drug: Liposomal daunorubicin
Drug: Gemtuzumab ozogamicin
Drug: Fludarabine
Drug: Cytarabine
Drug: Busulfan
Drug: Cyclophosphamide

First Posted Date: 2016-03-31

Last Posted Date: 2021-10-08

Lead Sponsor: University of Birmingham

Target Recruit Count: 700

Registration Number: NCT02724163

Locations: 🇦🇺
Monash Children's Hospital, Melbourne, Australia
🇦🇺
Women and Children's Hospital Adelaide, Adelaide, Australia
🇦🇺
Queensland Children's Hospital, Brisbane, Australia

and more 65 locations

Open-label Study of FT-2102 With or Without Azacitidine or Cytarabine in Patients With AML or MDS With an IDH1 Mutation

Phase 1

Completed

Conditions: Acute Myelogenous Leukemia
Myelodysplastic Syndrome
Acute Myeloid Leukemia

Interventions: Drug: FT-2102 (olutasidenib)
Drug: Azacitidine
Drug: Cytarabine

First Posted Date: 2016-03-25

Last Posted Date: 2024-11-05

Lead Sponsor: Forma Therapeutics, Inc.

Target Recruit Count: 336

Registration Number: NCT02719574

Locations: 🇺🇸
UCLA Medical Center, Los Angeles, California, United States
🇺🇸
University of Texas Southwestern Medical Center, Dallas, Texas, United States
🇦🇺
Box Hill Hospital, Monash University and Eastern Health Clinical School, Box Hill, Australia

and more 57 locations

Phase II Study of Fludarabine, Cytarabine (ARA-C) and Erwinase IV in Patients With Relapsed or Refractory Hematologic Malignancies

Phase 2

Withdrawn

Conditions: Hematologic Malignancy

Interventions: Drug: Fludarabine
Drug: Cytarabine
Drug: Erwinase

First Posted Date: 2016-03-24

Last Posted Date: 2018-06-26

Lead Sponsor: M.D. Anderson Cancer Center

Registration Number: NCT02718755

Study of Sensitization of Non-M3 AML Blasts to ATRA by Epigenetic Treatment With Tranylcypromine (TCP)

Phase 1

Conditions: Acute Myeloid Leukemia
Myelodysplastic Syndrome

Interventions: Drug: tranylcypromine
Drug: all-trans retinoic acid
Drug: cytarabine

First Posted Date: 2016-03-24

Last Posted Date: 2018-10-18

Lead Sponsor: Michael Luebbert

Target Recruit Count: 60

Registration Number: NCT02717884

Locations: 🇩🇪
Universitätsklinikum Freiburg, Medical School Freiburg, Freiburg, Germany
🇩🇪
Universitätsklinikum Tübingen, Medical School Tuebingen, Tübingen, Tuebingen, Germany
🇩🇪
Universitätsklinikum Heidelberg, Heidelberg, Baden-Wuerttemberg, Germany

and more 3 locations

Study for Patients With Newly Diagnosed, High-risk Acute Promyelocytic Leukemia

Phase 3

Active, not recruiting

Conditions: Acute Promyelocytic Leukemia

Interventions: Drug: Arsenic trioxide
Drug: Idarubicin
Drug: Cytarabine
Drug: Tretinoin
Drug: Mitoxantrone
Drug: Mercaptopurine
Drug: Methotrexate

First Posted Date: 2016-02-23

Last Posted Date: 2023-11-02

Lead Sponsor: Technische Universität Dresden

Target Recruit Count: 280

Registration Number: NCT02688140

Locations: 🇩🇪
OSHO study group, Multiple Locations, Germany
🇩🇪
SAL study group, Multiple Locations, Germany
🇳🇱
HOVON study group, Multiple Locations, Netherlands

and more 5 locations

Dasatinib in Combination With Chemotherapy for Relapsed or Refractory Core Binding Factor Acute Myeloid Leukemia

Phase 1

Withdrawn

Conditions: Acute Myeloid Leukemia

Interventions: Drug: Dasatinib
Drug: Fludarabine
Drug: Cytarabine
Drug: Idarubicin
Drug: Intrathecal (IT) cytarabine

First Posted Date: 2016-02-12

Last Posted Date: 2018-04-19

Lead Sponsor: Emory University

Registration Number: NCT02680951

Panobinostat With Fludarabine and Cytarabine for Treatment of Children With Acute Myeloid Leukemia or Myelodysplastic Syndrome

Phase 1

Terminated

Conditions: Myelodysplastic Syndrome
Acute Myeloid Leukemia

Interventions: Drug: Panobinostat
Drug: Fludarabine
Drug: Cytarabine
Drug: Intrathecal Triples
Drug: Leucovorin

First Posted Date: 2016-02-08

Last Posted Date: 2018-11-14

Lead Sponsor: St. Jude Children's Research Hospital

Target Recruit Count: 19

Registration Number: NCT02676323

Locations: 🇺🇸
Lucile Packard Children's Hospital Stanford University, Palo Alto, California, United States
🇺🇸
Rady Children's Hospital and Health Center, San Diego, California, United States
🇺🇸
Cook Children's Medical Center, Fort Worth, Texas, United States

and more 4 locations

Vinblastine/Prednisone Versus Single Therapy With Cytarabine for Langerhans Cell Histiocytosis (LCH)

Phase 3

Recruiting

Conditions: Langerhans Cell Histiocytosis

Interventions: Drug: Cytarabine
Drug: Vinblastine/prednisone

First Posted Date: 2016-02-02

Last Posted Date: 2024-08-05

Lead Sponsor: Baylor College of Medicine

Target Recruit Count: 124

Registration Number: NCT02670707

Locations: 🇺🇸
Cook Children's Health Care System, Fort Worth, Texas, United States
🇺🇸
Vannie Cook Children's Clinic, McAllen, Texas, United States
🇺🇸
Stanford Children's Hospital, Lucile Packard Children's Hospital, Palo Alto, California, United States

and more 8 locations

WEE1 Inhibitor AZD1775 With or Without Cytarabine in Treating Patients With Advanced Acute Myeloid Leukemia or Myelodysplastic Syndrome

Phase 2

Completed

Conditions: Chronic Myelomonocytic Leukemia
Recurrent Adult Acute Myeloid Leukemia
Myelodysplastic Syndrome With Isolated Del(5q)
Untreated Adult Acute Myeloid Leukemia
Myelodysplastic/Myeloproliferative Neoplasm
Previously Treated Myelodysplastic Syndrome

Interventions: Other: Laboratory Biomarker Analysis
Drug: Cytarabine
Other: Pharmacological Study
Other: Quality-of-Life Assessment
Drug: WEE1 Inhibitor AZD1775
Other: Questionnaire Administration

First Posted Date: 2016-01-28

Last Posted Date: 2019-09-06

Lead Sponsor: Mayo Clinic

Target Recruit Count: 3

Registration Number: NCT02666950

Locations: 🇺🇸
Mayo Clinic in Arizona, Scottsdale, Arizona, United States

Modified MRCUKALLⅫ/ECOGE2993 Regimen for ALL

Phase 2

Conditions: Leukaemia,Lymphoblastic

Interventions: Drug: Vincristine
Drug: Daunorubicin
Drug: Pegaspargase
Drug: Prednisone
Drug: Intrathecal Methotrexate
Drug: Cyclophosphamide
Drug: Cytarabine
Drug: 6-Mercaptopurine
Drug: Methotrexate
Drug: Etoposide
Drug: dexamethasone
Drug: thioguanine
Drug: intrathecal cytarabine

First Posted Date: 2016-01-21

Last Posted Date: 2017-06-19

Lead Sponsor: Sun Yat-sen University

Target Recruit Count: 100

Registration Number: NCT02660762

Locations: 🇨🇳
Sun Yat-sen University Cancer Center, GuangZhou, Guangdong, China

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