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

A Study of Gilteritinib (ASP2215) Combined With Chemotherapy in Children, Adolescents and Young Adults With FMS-like Tyrosine Kinase 3 (FLT3)/Internal Tandem Duplication (ITD) Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)

Phase 1

Recruiting

Conditions: Acute Myeloid Leukemia (AML)
Acute Myeloid Leukemia With FMS-like Tyrosine Kinase 3 (FLT3) Mutation / Internal Tandem Duplication (ITD)

Interventions: Drug: gilteritinib
Drug: fludarabine
Drug: cytarabine
Drug: granulocyte colony-stimulating factor (G-CSF)

First Posted Date: 2020-01-27

Last Posted Date: 2024-12-19

Lead Sponsor: Astellas Pharma Global Development, Inc.

Target Recruit Count: 97

Registration Number: NCT04240002

Locations: 🇩🇪
Site DE49001, Halle (Saale), Sachsen-Anhalt, Germany
🇮🇹
SIte IT39001, Roma, Italy
🇺🇸
Sarah Cannon Research Institute, Nashville, Tennessee, United States

and more 22 locations

Galinpepimut-S Versus Investigator's Choice of Best Available Therapy for Maintenance in AML CR2/CRp2

Phase 3

Active, not recruiting

Conditions: Acute Myeloid Leukemia

Interventions: Biological: Galinpepimut-S
Drug: Azacitidine
Biological: GM-CSF
Drug: Venetoclax
Other: Montanide
Drug: Decitabine
Drug: Cytarabine
Other: Observation

First Posted Date: 2020-01-18

Last Posted Date: 2024-04-09

Lead Sponsor: Sellas Life Sciences Group

Target Recruit Count: 128

Registration Number: NCT04229979

Locations: 🇺🇸
Mayo Clinic Jacksonville Florida, Jacksonville, Florida, United States
🇫🇷
CHU de Caen, Caen, France
🇬🇷
General Hospital of Athens "Evaggelismos", Athens, Greece

and more 70 locations

A Trial of Treatments to Assess the Effects on Outcome of Adults With AML and MDS Undergoing Allogeneic SCT

Phase 2

Active, not recruiting

Conditions: Acute Myeloid Leukaemia
High-risk Myelodysplastic Syndrome

Interventions: Drug: Fludarabine
Drug: Cytarabine
Drug: Vyxeos
Drug: Busulphan
Drug: Thiotepa

First Posted Date: 2020-01-03

Last Posted Date: 2023-05-10

Lead Sponsor: University of Birmingham

Target Recruit Count: 333

Registration Number: NCT04217278

Locations: 🇬🇧
King's College Hospital, London, United Kingdom
🇬🇧
Nottingham City Hospital, Nottingham, United Kingdom
🇬🇧
Manchester Royal Infirmary, Manchester, United Kingdom

and more 11 locations

Venetoclax, SL-401, and Chemotherapy for the Treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm

Phase 2

Recruiting

Conditions: Blastic Plasmacytoid Dendritic Cell Neoplasm

Interventions: Drug: Cyclophosphamide
Drug: Cytarabine
Drug: Dexamethasone
Drug: Doxorubicin
Drug: Mercaptopurine
Drug: Methotrexate
Drug: Methylprednisolone
Drug: Prednisone
Biological: Rituximab
Biological: Tagraxofusp-erzs
Drug: Venetoclax
Drug: Vincristine

First Posted Date: 2020-01-02

Last Posted Date: 2024-07-03

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 40

Registration Number: NCT04216524

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

BLAST MRD AML-1: BLockade of PD-1 Added to Standard Therapy to Target Measurable Residual Disease in Acute Myeloid Leukemia 1- A Randomized Phase 2 Study of Anti-PD-1 Pembrolizumab in Combination With Intensive Chemotherapy as Frontline Therapy in Patients With Acute Myeloid Leukemia

Phase 2

Active, not recruiting

Conditions: Acute Myeloid Leukemia
Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Acute Myeloid Leukemia Post Cytotoxic Therapy
Secondary Acute Myeloid Leukemia

Interventions: Procedure: Biospecimen Collection
Procedure: Bone Marrow Aspiration
Procedure: Bone Marrow Biopsy
Procedure: Computed Tomography
Drug: Cytarabine
Drug: Daunorubicin Hydrochloride
Procedure: Echocardiography
Procedure: Hematopoietic Cell Transplantation
Drug: Idarubicin Hydrochloride
Procedure: Multigated Acquisition Scan
Biological: Pembrolizumab
Procedure: Punch Biopsy

First Posted Date: 2020-01-02

Last Posted Date: 2024-12-04

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 50

Registration Number: NCT04214249

Locations: 🇺🇸
University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, United States
🇺🇸
UC Irvine Health/Chao Family Comprehensive Cancer Center, Orange, California, United States
🇺🇸
Wake Forest Baptist Health - Wilkes Medical Center, Wilkesboro, North Carolina, United States

and more 7 locations

CPX-351 or CLAG-M Regimen for the Treatment of Acute Myeloid Leukemia or Other High-Grade Myeloid Neoplasms in Medically Less-Fit Patients

Phase 2

Recruiting

Conditions: Myeloid Neoplasm
Acute Myeloid Leukemia

Interventions: Drug: Liposome-encapsulated Daunorubicin-Cytarabine
Drug: Cladribine
Other: Questionnaire Administration
Drug: Cytarabine
Biological: Recombinant Granulocyte Colony-Stimulating Factor
Drug: Mitoxantrone
Other: Quality-of-Life Assessment

First Posted Date: 2019-12-12

Last Posted Date: 2024-03-20

Lead Sponsor: Fred Hutchinson Cancer Center

Target Recruit Count: 60

Registration Number: NCT04195945

Locations: 🇺🇸
Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, United States

Continuous Infusion Chemotherapy (CI-CLAM) for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia or Other High-Grade Myeloid Neoplasms

Phase 1

Terminated

Conditions: Refractory Acute Myeloid Leukemia
Myeloid Neoplasm
Recurrent Acute Myeloid Leukemia

Interventions: Drug: Cladribine
Drug: Cytarabine
Biological: Recombinant Granulocyte Colony-Stimulating Factor
Drug: Mitoxantrone

First Posted Date: 2019-12-12

Last Posted Date: 2023-12-28

Lead Sponsor: University of Washington

Target Recruit Count: 13

Registration Number: NCT04196010

Locations: 🇺🇸
Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, United States

Testing the Addition of an Anti-cancer Drug, Navtemadlin, to the Usual Treatments (Cytarabine and Idarubicin) in Patients With Acute Myeloid Leukemia

Phase 1

Active, not recruiting

Conditions: Acute Myeloid Leukemia
Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome

Interventions: Drug: Cytarabine
Drug: Idarubicin Hydrochloride
Drug: Navtemadlin

First Posted Date: 2019-12-09

Last Posted Date: 2024-12-06

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 24

Registration Number: NCT04190550

Locations: 🇺🇸
Los Angeles General Medical Center, Los Angeles, California, United States
🇺🇸
USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States
🇺🇸
Northwestern University, Chicago, Illinois, United States

and more 3 locations

AML Patients Bearing FLT3 Mutations Based on Peripheral Blast Clearance

Phase 3

Recruiting

Conditions: Acute Myeloid Leukemia With FLT3/ITD Mutation

Interventions: Drug: Cytarabine
Drug: Daunorubicin
Drug: Midostaurin
Drug: Cytarabine HD

First Posted Date: 2019-11-22

Last Posted Date: 2022-03-02

Lead Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto

Target Recruit Count: 172

Registration Number: NCT04174612

Locations: 🇮🇹
Aou San Luigi Gonzaga - Orbassano - Scdu Ematologia Generale E Oncoematologia, Orbassano, Italy
🇮🇹
Aulss 3 Serenissima, Ospedale Dell'Angelo - Mestre - Uo Ematologia, Mestre, Italy
🇮🇹
Aou Policlinico P. Giaccone - Palermo - Uo Ematologia, Palermo, Italy

and more 17 locations

Flotetuzumab for the Treatment of Pediatric Recurrent or Refractory Acute Myeloid Leukemia

Phase 1

Active, not recruiting

Conditions: Recurrent Acute Myeloid Leukemia
Refractory Acute Myeloid Leukemia

Interventions: Drug: Cytarabine
Biological: Flotetuzumab

First Posted Date: 2019-11-12

Last Posted Date: 2025-01-09

Lead Sponsor: Children's Oncology Group

Target Recruit Count: 16

Registration Number: NCT04158739

Locations: 🇺🇸
Children's Healthcare of Atlanta - Arthur M Blank Hospital, Atlanta, Georgia, United States
🇺🇸
Children's Hospital of Alabama, Birmingham, Alabama, United States
🇺🇸
Children's Hospital Los Angeles, Los Angeles, California, United States

and more 16 locations

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