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

Risk-adapted Therapy for Adult Acute Myeloid Leukemia.

Phase 2

Completed

Conditions: Leukemia, Myelocytic, Acute

Interventions: Drug: Ara-C
Other: Autologous transplantation
Other: Allogeneic HLA-identical sibling transplantation
Other: CD34+ selection

First Posted Date: 2012-10-30

Last Posted Date: 2012-11-01

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

Target Recruit Count: 354

Registration Number: NCT01716793

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

and more 16 locations

Rituxan + BEAM and Auto Stem Cell Transplant for High Risk Lymphoma or Hodgkin's Disease

Not Applicable

Completed

Conditions: Hodgkin's Disease
Lymphoma

Interventions: Drug: Melphalan
Drug: Ara-C
Drug: VP-16
Drug: BCNU
Drug: Rituxan
Drug: Stem Cells

First Posted Date: 2012-10-10

Last Posted Date: 2018-12-19

Lead Sponsor: Baylor College of Medicine

Target Recruit Count: 75

Registration Number: NCT01702961

Locations: 🇺🇸
The Methodist Hospital, Houston, Texas, United States
🇺🇸
Texas Children's Hospital, Houston, Texas, United States

Expanded Cord Blood Cell Infusion Following Combination Chemotherapy in Younger Patients With Relapsed or Refractory Acute Myeloid Leukemia

Phase 1

Terminated

Conditions: Acute Leukemia of Ambiguous Lineage
Acute Myeloid Leukemia

Interventions: Biological: Ex-Vivo Expanded Cord Blood Progenitor Cell Infusion
Drug: Cytarabine
Drug: Filgrastim
Drug: Fludarabine Phosphate

First Posted Date: 2012-10-05

Last Posted Date: 2019-03-01

Lead Sponsor: Nohla Therapeutics, Inc.

Target Recruit Count: 7

Registration Number: NCT01701323

Locations: 🇺🇸
Emory University/Winship Cancer Institute, Atlanta, Georgia, United States
🇺🇸
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium, Seattle, Washington, United States

Therapy for Pediatric Relapsed or Refractory Precursor B-Cell Acute Lymphoblastic Leukemia and Lymphoma

Phase 2

Completed

Conditions: Recurrent B-Cell Childhood Acute Lymphoblastic Leukemia
Recurrent Childhood B-Lymphoblastic Lymphoma

Interventions: Drug: dexamethasone
Drug: vincristine sulfate
Biological: rituximab
Drug: clofarabine
Drug: cyclophosphamide
Drug: etoposide
Biological: aldesleukin
Drug: pegaspargase
Drug: methotrexate
Drug: mercaptopurine
Drug: cytarabine
Drug: mitoxantrone
Drug: teniposide
Drug: vinblastine
Biological: natural killer cell infusion
Other: laboratory biomarker analysis
Procedure: allogeneic hematopoietic stem cell transplantation
Drug: therapeutic hydrocortisone
Device: CliniMACS

First Posted Date: 2012-10-04

Last Posted Date: 2022-09-28

Lead Sponsor: St. Jude Children's Research Hospital

Target Recruit Count: 80

Registration Number: NCT01700946

Locations: 🇺🇸
Rady Children's Hospital and Health Center, San Diego, California, United States
🇺🇸
St. Jude Children's Research Hospital, Memphis, Tennessee, United States
🇺🇸
Cook Children's Medical Center, Fort Worth, Texas, United States

E7070, Idarubicin and Cytarabine in Relapsed AML and High-Risk Myelodysplastic Syndromes

Phase 2

Completed

Conditions: Leukemia

Interventions: Drug: E7070
Drug: Idarubicin
Drug: Cytarabine
Drug: Dexamethasone

First Posted Date: 2012-09-25

Last Posted Date: 2018-07-03

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 43

Registration Number: NCT01692197

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

Decitabine Combining Modified CAG Followed by HLA Haploidentical Peripheral Blood Mononuclear Cells Infusion for Elderly Patients With Acute Myeloid Leukemia(AML）

Phase 1

Completed

Conditions: MDS
AML

Interventions: Drug: Decitabine
Drug: Cytarabine
Drug: aclacinomycin
Drug: Granulocyte colony-stimulating factor
Other: HLA haploidentical mononuclear cells infusion

First Posted Date: 2012-09-21

Last Posted Date: 2016-02-25

Lead Sponsor: Chinese PLA General Hospital

Target Recruit Count: 29

Registration Number: NCT01690507

Locations: 🇨🇳
Chinese PLA General Hospital, Beijing, China
🇨🇳
Navy General Hospital, Beijing, Beijing, China

Lenalidomide Plus Chemotherapy for AML

Phase 1

Completed

Conditions: Acute Myelogenous Leukemia

Interventions: Drug: Lenalidomide
Drug: Mitoxantrone
Drug: Etoposide
Drug: Cytarabine

First Posted Date: 2012-09-10

Last Posted Date: 2016-03-17

Lead Sponsor: Massachusetts General Hospital

Target Recruit Count: 36

Registration Number: NCT01681537

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

Nilotinib and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia or Blastic Phase Chronic Myelogenous Leukemia

Phase 2

Withdrawn

Conditions: Blastic Phase Chronic Myelogenous Leukemia
Untreated Adult Acute Lymphoblastic Leukemia
B-cell Adult Acute Lymphoblastic Leukemia
Philadelphia Chromosome Positive Adult Precursor Acute Lymphoblastic Leukemia
Chronic Myelogenous Leukemia, BCR-ABL1 Positive

Interventions: Drug: nilotinib
Biological: rituximab
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: vincristine sulfate
Drug: methotrexate
Drug: cytarabine
Drug: prednisone
Drug: mesna
Drug: dexamethasone
Drug: leucovorin calcium

First Posted Date: 2012-08-21

Last Posted Date: 2015-10-30

Lead Sponsor: Mayo Clinic

Registration Number: NCT01670084

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

Rituximab/Bendamustine + Rituximab/Cytarabine for Mantle Cell Lymphoma

Phase 2

Active, not recruiting

Conditions: Mantle Cell Lymphoma

Interventions: Drug: Rituximab
Drug: Bendamustine
Drug: Cytarabine

First Posted Date: 2012-08-10

Last Posted Date: 2024-06-03

Lead Sponsor: Dana-Farber Cancer Institute

Target Recruit Count: 23

Registration Number: NCT01661881

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 Phase II Open-Label Study of High-Dose Cytarabine and Clofarabine in Adult Patients With Refractory or Relapsed Acute Myelogenous Leukemia or Refractory or Relapsed Acute Lymphoblastic Leukemia

Phase 2

Completed

Conditions: Leukemia

Interventions: Drug: clofarabine
Drug: cytarabine

First Posted Date: 2012-08-02

Last Posted Date: 2017-06-20

Lead Sponsor: Wake Forest University Health Sciences

Target Recruit Count: 39

Registration Number: NCT01656031

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

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