MedPath

Cytarabine

Generic Name
Cytarabine
Brand Names
Cytosar, Vyxeos
Drug Type
Small Molecule
Chemical Formula
C9H13N3O5
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
-

Clofarabine and Cytarabine in Treating Older Patients With AML or High-Risk MDS

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(16;16)(p13;q22)
Myelodysplastic Syndrome With Isolated Del(5q)
Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
Previously Treated Myelodysplastic Syndromes
Recurrent Adult Acute Myeloid Leukemia
Interventions
First Posted Date
2009-02-10
Last Posted Date
2017-07-11
Lead Sponsor
Fred Hutchinson Cancer Center
Target Recruit Count
35
Registration Number
NCT00839982
Locations
🇺🇸

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium, Seattle, Washington, United States

S0919 Idarubicin, Cytarabine, and Pravastatin in Treating Patients With Relapsed Acute Myeloid Leukemia

Phase 2
Completed
Conditions
Leukemia
Interventions
First Posted Date
2009-02-10
Last Posted Date
2023-05-03
Lead Sponsor
SWOG Cancer Research Network
Target Recruit Count
115
Registration Number
NCT00840177
Locations
🇺🇸

Cancer Center of Kansas-Independence, Independence, Kansas, United States

🇺🇸

Genesee Hematology Oncology PC, Flint, Michigan, United States

🇺🇸

Southeastern Medical Oncology Center-Jacksonville, Jacksonville, North Carolina, United States

and more 182 locations

Clofarabine, Cytarabine, and Idarubicin in Treating Patients With Intermediate-Risk or High-Risk Acute Myeloid Leukemia or High-Risk Myelodysplasia

Phase 1
Conditions
Leukemia
Myelodysplastic Syndromes
Interventions
First Posted Date
2009-02-06
Last Posted Date
2012-07-20
Lead Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Target Recruit Count
114
Registration Number
NCT00838240
Locations
🇧🇪

Institut Jules Bordet, Brussel, Belgium

🇮🇹

Azienda Ospedallera Universitaria - Policlinico Tor Vergata, Roma, Italy

🇮🇹

Univesita Degli Studi "La Sapienza", Roma, Italy

and more 7 locations

Idarubicin + Cytarabine and Lenalidomide in Patients With Myelodysplastic Syndrome (MDS), Acute Myeloid Leukemia (AML)

Phase 1
Completed
Conditions
Myelodysplastic Syndrome
Acute Myeloid Leukemia
Interventions
First Posted Date
2009-01-29
Last Posted Date
2020-12-22
Lead Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Target Recruit Count
51
Registration Number
NCT00831766
Locations
🇺🇸

H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States

🇺🇸

Cleveland Clinic - Taussig Cancer Institute, Cleveland, Ohio, United States

Phase I/IIa Trial to Investigate BI 6727 (Volasertib) as Monotherapy or in Combination With Cytarabine in Acute Myeloid Leukaemia

Phase 2
Completed
Conditions
Leukemia, Myeloid, Acute
Interventions
First Posted Date
2008-12-09
Last Posted Date
2023-10-03
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
180
Registration Number
NCT00804856
Locations
🇫🇷

HOP Edouard Herriot, Lyon Cedex 03, France

🇨🇦

Montreal General Hospital - McGill University Health Centre, Montreal, Quebec, Canada

🇫🇷

HOP Clémenceau, Hémato, Caen, Caen, France

and more 24 locations

Fludarabine Phosphate, Cytarabine, Filgrastim-sndz, Gemtuzumab Ozogamicin, and Idarubicin Hydrochloride in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome

Phase 2
Recruiting
Conditions
Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11
Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11
Acute Myeloid Leukemia With t(8;21); (q22; q22.1); RUNX1-RUNX1T1
Myelodysplastic Syndrome With Excess Blasts
t(8;21)
High Risk Myelodysplastic Syndrome
Inv(16)
t(16;16)
Untreated Adult Acute Myeloid Leukemia
de Novo Myelodysplastic Syndrome
Interventions
First Posted Date
2008-12-03
Last Posted Date
2024-05-07
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
270
Registration Number
NCT00801489
Locations
🇺🇸

M D Anderson Cancer Center, Houston, Texas, United States

Alvocidib, Cytarabine, and Mitoxantrone in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia

Phase 2
Completed
Conditions
Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome
Adult Acute Myeloid Leukemia With Del(5q)
Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
Adult Acute Minimally Differentiated Myeloid Leukemia (M0)
Adult Acute Monoblastic Leukemia (M5a)
Adult Acute Myeloblastic Leukemia Without Maturation (M1)
Adult Pure Erythroid Leukemia (M6b)
Secondary Acute Myeloid Leukemia
Untreated Adult Acute Myeloid Leukemia
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Interventions
Drug: alvocidib
Drug: mitoxantrone hydrochloride
Drug: cytarabine
Other: pharmacological study
Other: laboratory biomarker analysis
First Posted Date
2008-11-21
Last Posted Date
2018-08-07
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
78
Registration Number
NCT00795002
Locations
🇺🇸

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium, Seattle, Washington, United States

🇺🇸

Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, Maryland, United States

Combination Chemotherapy With or Without Donor Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia

Phase 2
Active, not recruiting
Conditions
Acute Lymphoblastic Leukemia
Adult B Acute Lymphoblastic Leukemia
Adult B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1
Adult L1 Acute Lymphoblastic Leukemia
Adult L2 Acute Lymphoblastic Leukemia
Adult T Acute Lymphoblastic Leukemia
Recurrent Adult Acute Lymphoblastic Leukemia
Interventions
First Posted Date
2008-11-18
Last Posted Date
2024-12-27
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
97
Registration Number
NCT00792948
Locations
🇺🇸

Cancer Center of Kansas-Kingman, Kingman, Kansas, United States

🇺🇸

Lawrence Memorial Hospital, Lawrence, Kansas, United States

🇺🇸

Southwest Medical Center, Liberal, Kansas, United States

and more 154 locations

Trial of CPX-351 in Newly Diagnosed Elderly AML Patients

Phase 2
Completed
Conditions
Acute Myeloid Leukemia
Interventions
First Posted Date
2008-11-11
Last Posted Date
2018-01-12
Lead Sponsor
Jazz Pharmaceuticals
Target Recruit Count
126
Registration Number
NCT00788892
Locations
🇺🇸

Cedars Sinai Medical Center, Los Angeles, California, United States

🇺🇸

North Shore University Hospital, Manhasset, New York, United States

🇺🇸

Arizona Cancer Center, Tucson, Arizona, United States

and more 25 locations

Clofarabine Plus Low-Dose Cytarabine Induction and Decitabine Consolidation in Frontline Acute Myeloid Leukemia (AML) and High-Risk Myelodysplastic Syndrome (MDS)

Phase 2
Completed
Conditions
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Interventions
First Posted Date
2008-10-23
Last Posted Date
2016-07-14
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
122
Registration Number
NCT00778375
Locations
🇺🇸

University of Texas MD Anderson Cancer Center, Houston, Texas, United States

© Copyright 2025. All Rights Reserved by MedPath