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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
-

Sulindac for Patients With AML

Phase 2
Withdrawn
Conditions
Acute Myeloid Leukemia
Interventions
First Posted Date
2013-04-30
Last Posted Date
2017-02-17
Lead Sponsor
Massachusetts General Hospital
Registration Number
NCT01843179
Locations
🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

High Dose Therapy and Autologous Stem Cell Transplantation Followed by Infusion of Chimeric Antigen Receptor (CAR) Modified T-Cells Directed Against CD19+ B-Cells for Relapsed and Refractory Aggressive B Cell Non-Hodgkin Lymphoma

Phase 1
Active, not recruiting
Conditions
Non-Hodgkin's Lymphoma
Interventions
Drug: Carmustine
Drug: Etoposide
Drug: Cytarabine
Drug: Melphalan
Biological: Pegfilgrastim
Biological: 19-28z T CELLS
Procedure: Autologous Stem Cell Transplantation
First Posted Date
2013-04-25
Last Posted Date
2024-05-29
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Target Recruit Count
17
Registration Number
NCT01840566
Locations
🇺🇸

Memorial Sloan Kettering Commack (Limited protocol activities), Commack, New York, United States

🇺🇸

Memorial Sloan Kettering Westchester (Limited Protocol Activities), Harrison, New York, United States

🇺🇸

Memorial Sloan Kettering Cancer Center, New York, New York, United States

and more 4 locations

Azacitidine, Cytarabine, and Mitoxantrone Hydrochloride in Treating Patients With High-Risk Acute Myeloid Leukemia

Phase 1
Completed
Conditions
Adult Acute Monoblastic Leukemia (M5a)
Adult Acute Myeloblastic Leukemia With Maturation (M2)
Adult Acute Megakaryoblastic Leukemia (M7)
Adult Acute Monocytic Leukemia (M5b)
Adult Acute Myeloblastic Leukemia Without Maturation (M1)
Adult Acute Myeloid Leukemia in Remission
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)
Interventions
First Posted Date
2013-04-24
Last Posted Date
2020-05-15
Lead Sponsor
University of Chicago
Target Recruit Count
50
Registration Number
NCT01839240
Locations
🇺🇸

University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States

Phase IIa Study Evaluating Safety and Efficacy of BL-8040 in Relapsed/Refractory AML Patients

Phase 2
Completed
Conditions
Acute Myeloid Leukemia
Interventions
Drug: Ara-C
Drug: BL-8040
First Posted Date
2013-04-24
Last Posted Date
2016-06-15
Lead Sponsor
BioLineRx, Ltd.
Target Recruit Count
42
Registration Number
NCT01838395
Locations
🇺🇸

Mayo Clinic, Jacksonville, Florida, United States

🇺🇸

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, United States

🇺🇸

Washington University School of Medicine, Saint Louis, Missouri, United States

and more 7 locations

Idarubicin, Cytarabine, and Pravastatin Sodium in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndromes

Not Applicable
Completed
Conditions
Adult Acute Minimally Differentiated Myeloid Leukemia (M0)
Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
Adult Pure Erythroid Leukemia (M6b)
Chronic Myelomonocytic Leukemia
Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable
Untreated Adult Acute Myeloid Leukemia
Adult Acute Megakaryoblastic Leukemia (M7)
Adult Acute Monoblastic Leukemia (M5a)
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Adult Acute Monocytic Leukemia (M5b)
Interventions
First Posted Date
2013-04-15
Last Posted Date
2017-11-17
Lead Sponsor
Fred Hutchinson Cancer Center
Target Recruit Count
24
Registration Number
NCT01831232
Locations
🇺🇸

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

Brentuximab Vedotin + Re-induction Chemotherapy for AML

Phase 1
Completed
Conditions
Acute Myelogenous Leukemia
Interventions
First Posted Date
2013-04-12
Last Posted Date
2020-04-14
Lead Sponsor
Massachusetts General Hospital
Target Recruit Count
22
Registration Number
NCT01830777
Locations
🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

Sirolimus, Idarubicin, and Cytarabine in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia

Early Phase 1
Completed
Conditions
Adult Acute Monoblastic Leukemia (M5a)
Adult Acute Myelomonocytic Leukemia (M4)
Adult Pure Erythroid Leukemia (M6b)
Adult Acute Megakaryoblastic Leukemia (M7)
Adult Acute Myeloblastic Leukemia With Maturation (M2)
Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
Adult Erythroleukemia (M6a)
Adult Acute Myeloblastic Leukemia Without Maturation (M1)
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Adult Acute Myeloid Leukemia With Del(5q)
Interventions
First Posted Date
2013-04-01
Last Posted Date
2023-02-03
Lead Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University
Target Recruit Count
55
Registration Number
NCT01822015
Locations
🇺🇸

Thomas Jefferson University, Philadelphia, Pennsylvania, United States

Daunorubicin Hydrochloride, Cytarabine, and Nilotinib in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia

Phase 2
Completed
Conditions
Untreated Adult Acute Myeloid Leukemia
Interventions
Drug: Cytarabine
Drug: Daunorubicin Hydrochloride
Other: Laboratory Biomarker Analysis
Drug: Nilotinib
Other: Pharmacological Study
First Posted Date
2013-03-07
Last Posted Date
2023-05-31
Lead Sponsor
Mayo Clinic
Target Recruit Count
34
Registration Number
NCT01806571
Locations
🇺🇸

Mayo Clinic in Arizona, Scottsdale, Arizona, United States

🇺🇸

Mayo Clinic, Rochester, Minnesota, United States

Cytarabine and Daunorubicin Hydrochloride or Idarubicin and Cytarabine With or Without Vorinostat in Treating Younger Patients With Previously Untreated Acute Myeloid Leukemia

Phase 3
Completed
Conditions
Acute Myeloid Leukemia
Untreated Adult Acute Myeloid Leukemia
Interventions
Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
Drug: Cytarabine
Drug: Daunorubicin Hydrochloride
Drug: Idarubicin
Other: Laboratory Biomarker Analysis
Drug: Vorinostat
First Posted Date
2013-03-01
Last Posted Date
2018-12-19
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
754
Registration Number
NCT01802333
Locations
🇺🇸

Flaget Memorial Hospital, Bardstown, Kentucky, United States

🇺🇸

Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States

🇺🇸

Brigham and Women's Hospital, Boston, Massachusetts, United States

and more 443 locations

Donor Stem Cell Transplant in Treating Patients With High Risk Acute Myeloid Leukemia

Phase 1
Terminated
Conditions
Adult Acute Megakaryoblastic Leukemia (M7)
Adult Acute Monoblastic Leukemia (M5a)
Adult Acute Monocytic Leukemia (M5b)
Adult Acute Myeloblastic Leukemia Without Maturation (M1)
Adult Erythroleukemia (M6a)
Childhood Acute Monoblastic Leukemia (M5a)
Adult Acute Myeloblastic Leukemia With Maturation (M2)
Adult Acute Myeloid Leukemia in Remission
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Adult Acute Myeloid Leukemia With Del(5q)
Interventions
Drug: mitoxantrone hydrochloride
Drug: cytarabine
Procedure: peripheral blood stem cell transplantation
Other: laboratory biomarker analysis
First Posted Date
2013-02-28
Last Posted Date
2018-03-30
Lead Sponsor
University of Southern California
Target Recruit Count
10
Registration Number
NCT01801046
Locations
🇺🇸

USC Norris Comprehensive Cancer Center, Los Angeles, California, United States

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