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

Vosaroxin and Infusional Cytarabine in Treating Patients With Untreated Acute Myeloid Leukemia

Phase 2

Active, not recruiting

Conditions: Acute Myeloid Leukemia With Multilineage Dysplasia
Acute Myeloid Leukemia
Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Therapy-Related Acute Myeloid Leukemia
Therapy-Related Myelodysplastic Syndrome
Myeloid Sarcoma
Secondary Acute Myeloid Leukemia

Interventions: Drug: Cytarabine
Drug: Vosaroxin

First Posted Date: 2016-01-18

Last Posted Date: 2024-05-03

Lead Sponsor: Vanderbilt-Ingram Cancer Center

Target Recruit Count: 42

Registration Number: NCT02658487

Locations: 🇺🇸
Yale University, New Haven, Connecticut, United States
🇺🇸
Medical University of South Carolina Hollings Cancer Center, Charleston, South Carolina, United States
🇺🇸
Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States

LY2510924, Idarubicin and Cytarabine in Patients With Relapsed or Refractory Acute Myeloid Leukemia

Phase 1

Completed

Conditions: Leukemia

Interventions: Drug: LY2510924
Drug: Idarubicin
Drug: Cytarabine

First Posted Date: 2016-01-12

Last Posted Date: 2019-11-15

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 36

Registration Number: NCT02652871

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

Prexasertib (LY2606368), Cytarabine, and Fludarabine in Patients With Relapsed or Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome

Phase 1

Completed

Conditions: Chronic Myelomonocytic Leukemia
Recurrent Acute Myeloid Leukemia
Recurrent High Risk Myelodysplastic Syndrome
Refractory High Risk Myelodysplastic Syndrome
Refractory Acute Myeloid Leukemia

Interventions: Drug: Cytarabine
Drug: Fludarabine Phosphate
Other: Laboratory Biomarker Analysis
Drug: Prexasertib

First Posted Date: 2016-01-07

Last Posted Date: 2023-10-04

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 15

Registration Number: NCT02649764

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

Liposome-encapsulated Daunorubicin-Cytarabine, Fludarabine Phosphate, Cytarabine, and Filgrastim in Treating Younger Patients With Relapsed or Refractory Acute Myeloid Leukemia

Phase 1

Completed

Conditions: Acute Myeloid Leukemia Post Cytotoxic Therapy
Secondary Acute Myeloid Leukemia
Recurrent Childhood Acute Myeloid Leukemia

Interventions: Drug: Cytarabine
Biological: Filgrastim
Drug: Fludarabine Phosphate
Other: Laboratory Biomarker Analysis
Drug: Liposome-encapsulated Daunorubicin-Cytarabine
Other: Pharmacological Study

First Posted Date: 2015-12-30

Last Posted Date: 2023-09-08

Lead Sponsor: Children's Oncology Group

Target Recruit Count: 38

Registration Number: NCT02642965

Locations: 🇺🇸
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
🇺🇸
Maine Children's Cancer Program, Scarborough, Maine, United States
🇨🇦
Kingston Health Sciences Centre, Kingston, Ontario, Canada

and more 70 locations

Genomics-Based Target Therapy for Children With Relapsed or Refractory Malignancy

Phase 2

Conditions: Relapsed Pediatric Solid Tumor
Refractory Pediatric Solid Tumor
Relapsed Pediatric AML
Refractory Pediatric AML

Interventions: Procedure: CancerSCAN™
Drug: Ifosfamide
Drug: Carboplatin
Drug: Etoposide
Drug: Fludarabine
Drug: Cytarabine
Drug: Pazopanib
Drug: Sorafenib
Drug: Axitinib
Drug: Crizotinib
Drug: Dasatinib
Drug: Erlotinib
Drug: Everolimus
Drug: Imatinib
Drug: Ruxolitinib
Drug: Vandetanib
Drug: Vemurafenib
Drug: Trastuzumab

First Posted Date: 2015-12-23

Last Posted Date: 2020-03-19

Lead Sponsor: Samsung Medical Center

Target Recruit Count: 90

Registration Number: NCT02638428

Locations: 🇰🇷
Samsung Medical Center, Seoul, Korea, Republic of

Ibrutinib, Idarubicin and Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

Phase 1

Terminated

Conditions: Recurrent Adult Acute Myeloid Leukemia

Interventions: Drug: Cytarabine
Drug: Ibrutinib
Drug: Idarubicin

First Posted Date: 2015-12-18

Last Posted Date: 2018-05-14

Lead Sponsor: Steven E. Coutre

Target Recruit Count: 2

Registration Number: NCT02635074

Locations: 🇺🇸
Stanford University, School of Medicine, Palo Alto, California, United States

Safety Study of AG-120 or AG-221 in Combination With Induction and Consolidation Therapy in Participants With Newly Diagnosed Acute Myeloid Leukemia (AML) With an IDH1 and/or IDH2 Mutation

Phase 1

Active, not recruiting

Conditions: Newly Diagnosed Acute Myeloid Leukemia (AML)
AML Arising After Exposure to Genotoxic Injury
Untreated AML
AML Arising From Myelodysplastic Syndrome (MDS)
AML Arising From Antecedent Hematologic Disorder (AHD)

Interventions: Drug: AG-120
Drug: AG-221
Drug: cytarabine
Drug: idarubicin
Drug: daunorubicin
Drug: mitoxantrone
Drug: etoposide

First Posted Date: 2015-12-17

Last Posted Date: 2024-07-25

Lead Sponsor: Institut de Recherches Internationales Servier

Target Recruit Count: 153

Registration Number: NCT02632708

Locations: 🇺🇸
UCLA Medical Center, Los Angeles, California, United States
🇺🇸
Hackensack University Medical Center, Hackensack, New Jersey, United States
🇺🇸
Johns Hopkins University, Baltimore, Maryland, United States

and more 14 locations

Pilot Study of Crenolanib Combined With Standard Salvage Chemotherapy in Subjects With R/R AML

Phase 1

Completed

Conditions: Relapsed/Refractory Acute Myeloid Leukemia (AML)

Interventions: Drug: Crenolanib
Drug: Mitoxantrone
Drug: Cytarabine
Drug: Fludarabine
Drug: Etoposide
Drug: G-CSF
Drug: Idarubicin

First Posted Date: 2015-12-10

Last Posted Date: 2023-12-20

Lead Sponsor: Arog Pharmaceuticals, Inc.

Target Recruit Count: 16

Registration Number: NCT02626338

Locations: 🇺🇸
City of Hope Medical Center, Duarte, California, United States
🇺🇸
Houston Methodist, Houston, Texas, United States
🇺🇸
University of Arkansas, Little Rock, Arkansas, United States

and more 1 locations

Donor Cellular Therapy After Cytarabine in Treating Patients With Intermediate-Risk Acute Myeloid Leukemia in Remission

Phase 2

Withdrawn

Conditions: Adult Acute Myeloid Leukemia in Remission
Childhood Acute Myeloid Leukemia in Remission

Interventions: Drug: Cytarabine
Other: Laboratory Biomarker Analysis
Procedure: Peripheral Blood Stem Cell Transplantation
Biological: Therapeutic Allogeneic Lymphocytes
Biological: G-CSF mobilized peripheral blood cells

First Posted Date: 2015-10-27

Last Posted Date: 2018-11-09

Lead Sponsor: University of Southern California

Registration Number: NCT02587871

Locations: 🇺🇸
USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States

Biomarkers in Predicting Treatment Response to Sirolimus and Chemotherapy in Patients With High-Risk Acute Myeloid Leukemia

Phase 2

Completed

Conditions: Recurrent Adult Acute Myeloid Leukemia
Secondary Acute Myeloid Leukemia
Untreated Adult Acute Myeloid Leukemia

Interventions: Drug: Sirolimus
Drug: Mitoxantrone
Drug: Etoposide
Drug: Cytarabine

First Posted Date: 2015-10-22

Last Posted Date: 2023-10-10

Lead Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University

Target Recruit Count: 39

Registration Number: NCT02583893

Locations: 🇺🇸
Thomas Jefferson University, Philadelphia, Pennsylvania, United States

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