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

Zevalin/BEAM/Rituximab vs BEAM/Rituximab With or Without Rituximab in Autologous Stem Cell Transplantation

Phase 2

Completed

Conditions: Lymphoma
Diffuse Large Cell Lymphoma

Interventions: Drug: Zevalin
Drug: Carmustine
Drug: Etoposide
Drug: Cytarabine
Drug: Melphalan
Drug: Rituximab
Procedure: Stem Cell Transplant

First Posted Date: 2008-01-11

Last Posted Date: 2021-02-02

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 30

Registration Number: NCT00591630

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

Dose Escalation Phase I/II Study of Lovastatin With High-Dose Cytarabine for Refractory or Relapsed AML

Phase 1

Terminated

Conditions: Acute Myeloid Leukemia

Interventions: Drug: Cytarabine
Drug: Lovastatin

First Posted Date: 2007-12-31

Last Posted Date: 2018-01-05

Lead Sponsor: University of Iowa

Target Recruit Count: 23

Registration Number: NCT00583102

Locations: 🇺🇸
Holden Comprehensive Cancer Center, Iowa City, Iowa, United States

Chemotherapy With Monoclonal Antibody and Radioimmunotherapy for High-Risk B-Cell Non-Hodgkins Lymphoma

Phase 2

Completed

Conditions: Lymphoma, B-Cell

Interventions: Drug: cyclophosphamide
Drug: etoposide
Drug: rituximab
Drug: cytarabine
Drug: doxorubicin
Drug: tositumomab

First Posted Date: 2007-12-20

Last Posted Date: 2017-05-30

Lead Sponsor: Duke University

Target Recruit Count: 39

Registration Number: NCT00577629

Locations: 🇺🇸
Duke University Medical Center, Durham, North Carolina, United States

Fludarabine, Mitoxantrone, and Dexamethasone (FND) Plus Rituximab for Lymphoma Patients

Phase 3

Completed

Conditions: Lymphoma

Interventions: Drug: Fludarabine
Drug: Novantrone
Drug: Decadron
Drug: Interferon
Drug: Rituximab
Drug: Doxorubicin
Drug: Vincristine
Drug: Bleomycin
Drug: Cyclophosphamide
Drug: Etoposide
Drug: Cisplatin
Drug: Ara-C
Drug: Methyl-Prednisolone
Drug: Procarbazine
Drug: Prednisone

First Posted Date: 2007-12-20

Last Posted Date: 2020-11-16

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 210

Registration Number: NCT00577993

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

Pilot Trial of Arsenic + Cytarabine in Patients With Myelofibrosis

Early Phase 1

Completed

Conditions: Myelofibrosis

Interventions: Drug: arsenic trioxide
Drug: cytarabine

First Posted Date: 2007-12-12

Last Posted Date: 2017-03-03

Lead Sponsor: Weill Medical College of Cornell University

Target Recruit Count: 21

Registration Number: NCT00572065

Locations: 🇺🇸
Weill Cornell Medical College, New York, New York, United States

Phase I/II Study of 5-Azacytidine With Ara-C in Patients With Relapsed/Refractory Acute Myelogenous Leukemia (AML) or High Risk Myelodysplastic Syndrome (MDS)

Phase 1

Completed

Conditions: Acute Myelogenous Leukemia
Myelodysplastic Syndrome
Leukemia

Interventions: Drug: Azacitidine
Drug: Ara-C

First Posted Date: 2007-12-06

Last Posted Date: 2012-08-01

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 36

Registration Number: NCT00569010

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

Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

Phase 2

Conditions: Leukemia

Interventions: Drug: cyclophosphamide
Drug: cytarabine
Drug: daunorubicin hydrochloride
Drug: dexamethasone
Drug: doxorubicin hydrochloride
Drug: mercaptopurine
Drug: methotrexate
Drug: pegaspargase
Drug: thioguanine
Drug: vincristine sulfate
Radiation: radiation therapy

First Posted Date: 2007-11-15

Last Posted Date: 2021-08-18

Lead Sponsor: Alliance for Clinical Trials in Oncology

Target Recruit Count: 318

Registration Number: NCT00558519

Combination Chemotherapy With or Without Lestaurtinib in Treating Younger Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

Phase 3

Completed

Conditions: Acute Undifferentiated Leukemia
Acute Lymphoblastic Leukemia
Childhood T Acute Lymphoblastic Leukemia

Interventions: Drug: Asparaginase
Procedure: Biospecimen Collection
Procedure: Bone Marrow Biopsy
Drug: Cyclophosphamide
Drug: Cytarabine
Drug: Daunorubicin Hydrochloride
Drug: Dexamethasone
Procedure: Echocardiography
Drug: Etoposide
Biological: Filgrastim
Other: Laboratory Biomarker Analysis
Drug: Leucovorin Calcium
Drug: Lestaurtinib
Drug: Mercaptopurine
Drug: Methotrexate
Drug: Methylprednisolone
Procedure: Multigated Acquisition Scan
Drug: Pegaspargase
Other: Pharmacological Study
Drug: Prednisone
Drug: Therapeutic Hydrocortisone
Drug: Vincristine Sulfate

First Posted Date: 2007-11-12

Last Posted Date: 2024-07-15

Lead Sponsor: Children's Oncology Group

Target Recruit Count: 218

Registration Number: NCT00557193

Locations: 🇺🇸
Children's Hospital of Pittsburgh of UPMC, Pittsburgh, Pennsylvania, United States
🇺🇸
Connecticut Children's Medical Center, Hartford, Connecticut, United States
🇺🇸
MedStar Georgetown University Hospital, Washington, District of Columbia, United States

and more 167 locations

Phase II Study to Evaluate the Combination of Rituximab and DepoCyte® in the C5R Chemotherapy Protocol in Patients Between the Ages of 18 and 60 Years With Primary Cerebral Non-Hodgkin Lymphoma and Systemic Diffuse Large B-cell Lymphoma With Neuromeningeal Invasion at Diagnosis

Phase 2

Completed

Conditions: Lymphoma, Non-Hodgkin
Diffuse Large B-cell Lymphoma

Interventions: Drug: Rituximab
Drug: Cytarabine

First Posted Date: 2007-11-06

Last Posted Date: 2018-08-23

Lead Sponsor: Lymphoma Study Association

Target Recruit Count: 60

Registration Number: NCT00553943

Locations: 🇧🇪
Hôpital Saint Joseph, Arlon, Belgium
🇧🇪
A. Z. Sint-Jan, Bruges, Belgium
🇧🇪
CH Notre Dame, Charleroi, Belgium

and more 42 locations

Different Therapies in Treating Infants With Newly Diagnosed Acute Leukemia

Not Applicable

Conditions: Leukemia

First Posted Date: 2007-10-30

Last Posted Date: 2019-07-30

Lead Sponsor: Dutch Childhood Oncology Group

Target Recruit Count: 445

Registration Number: NCT00550992

Locations: 🇨🇿
University Hospital Motol, Prague, Czechia
🇫🇷
CHR Hotel Dieu, Nantes, France
🇺🇸
Children's Hospital and Regional Medical Center - Seattle, Seattle, Washington, United States

and more 10 locations

Drug Development Updates

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