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 Followed by Clofarabine, Idarubicin, and Cytarabine in Acute Leukemia

Phase 1

Completed

Conditions: Leukemia

Interventions: Drug: Decitabine
Drug: Idarubicin
Drug: Cytarabine
Drug: Clofarabine

First Posted Date: 2013-02-20

Last Posted Date: 2019-05-30

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 65

Registration Number: NCT01794702

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

Donor Natural Killer Cells in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

Phase 1

Completed

Conditions: Refractory Acute Myeloid Leukemia
Recurrent Adult Acute Myeloid Leukemia

Interventions: Drug: Cytarabine
Biological: Filgrastim
Biological: Filgrastim-sndz
Drug: Fludarabine Phosphate
Other: Laboratory Biomarker Analysis
Biological: Membrane-bound Interleukin-21-Expanded Haploidentical Natural Killer Cells

First Posted Date: 2013-02-08

Last Posted Date: 2021-06-21

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 30

Registration Number: NCT01787474

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

Alisertib for Acute Myeloid Leukemia

Phase 1

Completed

Conditions: Acute Myelogenous Leukemia

Interventions: Drug: Cytarabine
Drug: Idarubicin
Drug: Alisertib

First Posted Date: 2013-01-30

Last Posted Date: 2017-02-17

Lead Sponsor: Massachusetts General Hospital

Target Recruit Count: 22

Registration Number: NCT01779843

Locations: 🇺🇸
Brigham and Women's Hospital, Boston, Massachusetts, United States
🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States

A Study of RO5503781 as a Single Agent or in Combination With Cytarabine in Participants With Acute Myelogenous Leukemia

Phase 1

Completed

Conditions: Myelogenous Leukemia, Acute

Interventions: Drug: RO5503781 MBP
Drug: RO5503781 SDP
Drug: Idarubicin
Drug: Daunorubicin
Drug: Cytarabine

First Posted Date: 2013-01-23

Last Posted Date: 2017-01-25

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 122

Registration Number: NCT01773408

Locations: 🇺🇸
USC Norris Cancer Center, Los Angeles, California, United States
🇺🇸
Cancer Therapy & Research Ctr; Dept Institute for Drug Development, San Antonio, Texas, United States
🇨🇦
McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology, Montreal, Quebec, Canada

and more 9 locations

Genetically Modified Peripheral Blood Stem Cell Transplant in Treating Patients With HIV-Associated Non-Hodgkin or Hodgkin Lymphoma

Not Applicable

Withdrawn

Conditions: HIV-associated Hodgkin Lymphoma
Recurrent Adult Hodgkin Lymphoma
Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
Recurrent Mycosis Fungoides/Sezary Syndrome
Splenic Marginal Zone Lymphoma
Stage IV AIDS-related Lymphoma
AIDS-related Diffuse Small Cleaved Cell Lymphoma
AIDS-related Peripheral/Systemic Lymphoma
Hepatosplenic T-cell Lymphoma
Peripheral T-cell Lymphoma

Interventions: Drug: carmustine
Drug: cytarabine
Drug: melphalan
Drug: etoposide
Drug: O6-benzylguanine
Procedure: autologous hematopoietic stem cell transplantation
Procedure: peripheral blood stem cell transplantation
Other: laboratory biomarker analysis

First Posted Date: 2013-01-17

Last Posted Date: 2015-05-07

Lead Sponsor: Fred Hutchinson Cancer Center

Registration Number: NCT01769911

Locations: 🇺🇸
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium, Seattle, Washington, United States

CPI-613, Cytarabine, and Mitoxantrone Hydrochloride in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

Phase 1

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)
Recurrent Adult Acute Myeloid Leukemia

Interventions: Drug: CPI-613
Drug: cytarabine
Drug: mitoxantrone hydrochloride
Other: laboratory biomarker analysis
Other: pharmacological study

First Posted Date: 2013-01-16

Last Posted Date: 2018-07-03

Lead Sponsor: Wake Forest University Health Sciences

Target Recruit Count: 67

Registration Number: NCT01768897

Locations: 🇺🇸
Comprehensive Cancer Center of Wake Forest University, Winston-Salem, North Carolina, United States

Bortezomib and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia

Phase 2

Completed

Conditions: Recurrent Adult Acute Lymphoblastic Leukemia (ALL)
Ph-positive Adult Acute Lymphoblastic Leukemia (ALL)
B-cell Adult Acute Lymphoblastic Leukemia (ALL)
T-cell Adult Acute Lymphoblastic Leukemia (ALL)

Interventions: Drug: Bortezomib
Drug: Doxorubicin hydrochloride (HCl)
Drug: PEG-Asparaginase
Drug: Vincristine sulfate
Drug: Dexamethasone
Drug: Cytarabine
Drug: Methotrexate

First Posted Date: 2013-01-16

Last Posted Date: 2018-11-14

Lead Sponsor: Stanford University

Target Recruit Count: 18

Registration Number: NCT01769209

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

Decitabine Followed by Mitoxantrone Hydrochloride, Etoposide, and Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndromes

Phase 1

Completed

Conditions: Recurrent Adult Acute Myeloid Leukemia
Previously Treated Myelodysplastic Syndrome

Interventions: Drug: Cytarabine
Drug: Decitabine
Drug: Etoposide
Other: Laboratory Biomarker Analysis
Drug: Mitoxantrone Hydrochloride

First Posted Date: 2012-11-20

Last Posted Date: 2019-02-07

Lead Sponsor: Fred Hutchinson Cancer Center

Target Recruit Count: 52

Registration Number: NCT01729845

Locations: 🇺🇸
Kadlec Clinic Hematology and Oncology, Kennewick, Washington, United States
🇺🇸
Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, United States
🇺🇸
EvergreenHealth Medical Center, Kirkland, Washington, United States

Risk Adapted Treatment for Primary Acute Myeloid Leukemia (AML)

Phase 2

Completed

Conditions: Leukemia, Myelocytic, Acute

Interventions: Drug: Ara-C
Other: Autologous peripheral blood stem cell transplantation.
Other: Allogeneic matched related or unrelated donor transplant.
Drug: G-CSF
Other: CD34+ selection.
Other: Mylotarg purging before autologous PBSC transplantation

First Posted Date: 2012-11-08

Last Posted Date: 2012-11-08

Lead Sponsor: Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias

Target Recruit Count: 862

Registration Number: NCT01723657

Locations: 🇪🇸
ICO Hospital Universitari de Bellvitge, L'Hospitalet del Llobregat, Barcelona, Spain
🇪🇸
Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, Spain
🇪🇸
Hospital A Coruña, A Coruña, Coruña, Spain

and more 18 locations

Volasertib in Combination With Low-dose Cytarabine in Patients Aged 65 Years and Above With Previously Untreated Acute Myeloid Leukaemia, Who Are Ineligible for Intensive Remission Induction Therapy (POLO-AML-2)

Phase 3

Completed

Conditions: Leukemia, Myeloid, Acute

Interventions: Drug: Placebo
Drug: Volasertib
Drug: Cytarabine

First Posted Date: 2012-11-06

Last Posted Date: 2023-02-08

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 666

Registration Number: NCT01721876

Locations: 🇨🇦
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
🇫🇷
HOP Côte de Nacre, Caen, France
🇫🇷
HOP Haut-Lévêque, Pessac, France

and more 119 locations

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