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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
-

Radiolabeled Monoclonal Antibody and Combination Chemotherapy Before Stem Cell Transplant in Treating Patients With High-Risk Lymphoid Malignancies

Phase 1
Completed
Conditions
Refractory Hodgkin Lymphoma
Recurrent Hodgkin Lymphoma
Refractory T-Cell Non-Hodgkin Lymphoma
Recurrent B-Cell Non-Hodgkin Lymphoma
Recurrent T-Cell Non-Hodgkin Lymphoma
Refractory Mantle Cell Lymphoma
Recurrent Mantle Cell Lymphoma
Refractory B-Cell Non-Hodgkin Lymphoma
Interventions
Procedure: Autologous Hematopoietic Stem Cell Transplantation
Drug: Carmustine
Drug: Cytarabine
Drug: Etoposide
Other: Laboratory Biomarker Analysis
Drug: Melphalan
Procedure: Peripheral Blood Stem Cell Transplantation
Radiation: Yttrium Y 90 Anti-CD45 Monoclonal Antibody BC8
First Posted Date
2013-08-13
Last Posted Date
2020-08-04
Lead Sponsor
Fred Hutchinson Cancer Center
Target Recruit Count
20
Registration Number
NCT01921387
Locations
🇺🇸

Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, United States

A Novel "Pediatric-Inspired" Regimen With Reduced Myelosuppressive Drugs for Adults (Aged 18-60) With Newly Diagnosed Ph Negative Acute Lymphoblastic Leukemia

First Posted Date
2013-08-12
Last Posted Date
2023-10-24
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Target Recruit Count
39
Registration Number
NCT01920737
Locations
🇺🇸

Weill Cornell Medical Center, New York, New York, United States

🇺🇸

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

🇺🇸

Duke University Medical Center, Durham, North Carolina, United States

and more 1 locations

Lenalidomide and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

Phase 1
Terminated
Conditions
Adult Acute Megakaryoblastic Leukemia (M7)
Adult Acute Monoblastic Leukemia (M5a)
Adult Acute Monocytic Leukemia (M5b)
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Adult Acute Myeloid Leukemia With Del(5q)
Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
Adult Pure Erythroid Leukemia (M6b)
Adult Acute Myeloblastic Leukemia With Maturation (M2)
Adult Acute Myeloblastic Leukemia Without Maturation (M1)
Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
Interventions
First Posted Date
2013-07-22
Last Posted Date
2018-10-29
Lead Sponsor
Stanford University
Target Recruit Count
17
Registration Number
NCT01904643
Locations
🇺🇸

Stanford University, School of Medicine, Stanford, California, United States

Quizartinib With Azacitidine or Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome

Phase 1
Completed
Conditions
FLT3 Gene Mutation Negative
Recurrent Acute Myeloid Leukemia
Recurrent Chronic Myelomonocytic Leukemia
Refractory Acute Myeloid Leukemia
Recurrent Myelodysplastic Syndrome
Refractory Chronic Myelomonocytic Leukemia
FLT3 Internal Tandem Duplication Positive
Refractory Myelodysplastic Syndrome
Interventions
First Posted Date
2013-07-04
Last Posted Date
2024-10-18
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
73
Registration Number
NCT01892371
Locations
🇺🇸

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

A Safety and Efficacy Study of Eltrombopag in Subjects With AML

Phase 2
Completed
Conditions
Acute Leukaemia
Interventions
First Posted Date
2013-07-02
Last Posted Date
2019-09-11
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
148
Registration Number
NCT01890746
Locations
🇷🇺

Novartis Investigative Site, Tula, Russian Federation

A Study of Vismodegib in Patients With Relapsed/Refractory Acute Myelogenous Leukemia and Relapsed Refractory High-Risk Myelodysplastic Syndrome

Phase 2
Terminated
Conditions
Myelodysplastic Syndromes, Myelogenous Leukemia, Acute
Interventions
First Posted Date
2013-06-19
Last Posted Date
2015-12-15
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
38
Registration Number
NCT01880437

Dasatinib, Cytarabine, and Idarubicin in Treating Patients With High-Risk Acute Myeloid Leukemia

Phase 1
Terminated
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
Secondary Acute Myeloid Leukemia
Untreated Adult Acute Myeloid Leukemia
Interventions
Drug: cytarabine
Drug: idarubicin
Drug: dasatinib
Other: laboratory biomarker analysis
First Posted Date
2013-06-13
Last Posted Date
2022-03-31
Lead Sponsor
City of Hope Medical Center
Target Recruit Count
20
Registration Number
NCT01876953
Locations
🇺🇸

City of Hope Medical Center, Duarte, California, United States

Cytarabine With or Without SCH 900776 in Treating Adult Patients With Relapsed Acute Myeloid Leukemia

Phase 2
Completed
Conditions
Adult Acute Myeloid Leukemia With Maturation
Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); RUNX1-RUNX1T1
Adult Acute Myelomonocytic Leukemia
Adult Erythroleukemia
Alkylating Agent-Related Acute Myeloid Leukemia
Adult Acute Megakaryoblastic Leukemia
Adult Acute Monoblastic Leukemia
Adult Acute Monocytic Leukemia
Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11
Adult Acute Myeloid Leukemia With Minimal Differentiation
Interventions
Drug: Cytarabine
Drug: CHK1 Inhibitor SCH 900776
Other: Laboratory Biomarker Analysis
First Posted Date
2013-06-06
Last Posted Date
2016-09-01
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
32
Registration Number
NCT01870596
Locations
🇺🇸

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

🇺🇸

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

🇺🇸

Blood and Marrow Transplant Group of Georgia, Atlanta, Georgia, United States

and more 2 locations

A Phase I Study of 5-Azacytidine in Combination With Chemotherapy for Children With Relapsed or Refractory ALL or AML

Phase 1
Completed
Conditions
Lymphoblastic Leukemia, Acute, Childhood
Myelogenous Leukemia, Acute, Childhood
Interventions
First Posted Date
2013-05-23
Last Posted Date
2021-06-09
Lead Sponsor
Therapeutic Advances in Childhood Leukemia Consortium
Target Recruit Count
15
Registration Number
NCT01861002
Locations
🇺🇸

Children's National Medical Center, Washington, District of Columbia, United States

🇨🇦

Sainte-Justine University Hospital Center, Montreal, Quebec, Canada

🇺🇸

Children's Mercy Hospitals and Clinics, Kansas City, Missouri, United States

and more 20 locations

Metformin+Cytarabine for the Treatment of Relapsed/Refractory AML

Phase 1
Terminated
Conditions
Adult Acute Minimally Differentiated Myeloid Leukemia (M0)
Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
Adult Erythroleukemia (M6a)
Blastic Phase Chronic Myelogenous Leukemia
Adult Acute Megakaryoblastic Leukemia (M7)
Recurrent Adult Acute Myeloid Leukemia
Adult Acute Monocytic Leukemia (M5b)
Adult Acute Myeloblastic Leukemia With Maturation (M2)
Adult Acute Myeloblastic Leukemia Without Maturation (M1)
Interventions
Drug: metformin hydrochloride
Drug: cytarabine
Other: laboratory biomarker analysis
First Posted Date
2013-05-08
Last Posted Date
2019-01-31
Lead Sponsor
Northwestern University
Target Recruit Count
2
Registration Number
NCT01849276
Locations
🇺🇸

Northwestern University, Chicago, Illinois, United States

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