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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
-

Phase II Study of V-BEAM Conditioning Regimen Prior to Second Autologous Stem Cell Transplantation

Phase 2
Terminated
Conditions
Multiple Myeloma
Interventions
First Posted Date
2012-07-31
Last Posted Date
2014-10-15
Lead Sponsor
Washington University School of Medicine
Target Recruit Count
10
Registration Number
NCT01653418
Locations
🇺🇸

Washington University School of Medicine, St. Louis, Missouri, United States

A Study of RO5429083 Alone or in Combination With Cytarabine in Patients With Acute Myelogenous Leukemia

Phase 1
Completed
Conditions
Myelogenous Leukemia, Acute
Interventions
Drug: RO5429083
Drug: cytarabine
First Posted Date
2012-07-16
Last Posted Date
2016-11-02
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
44
Registration Number
NCT01641250

Tosedostat and Cytarabine or Azacitidine in Treating Older Participants With Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome

Phase 1
Terminated
Conditions
High Risk Myelodysplastic Syndrome
Acute Myeloid Leukemia
Interventions
First Posted Date
2012-07-10
Last Posted Date
2020-04-13
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
18
Registration Number
NCT01636609
Locations
🇺🇸

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

A Study of RO5045337 in Combination With Cytarabine in Patients With Acute Myelogenous Leukemia

Phase 1
Completed
Conditions
Myelogenous Leukemia, Acute
Interventions
Drug: RO5045377
Drug: cytarabine
First Posted Date
2012-07-09
Last Posted Date
2016-11-02
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
43
Registration Number
NCT01635296

Decitabine, Cytarabine, and Daunorubicin Hydrochloride in Treating Patients With Acute Myeloid Leukemia

Phase 2
Conditions
Acute Myeloid Leukemia
Adult Acute Basophilic Leukemia
Adult Acute Monoblastic Leukemia
Adult Acute Monocytic Leukemia
Adult Acute Myeloid Leukemia With Maturation
Adult Acute Myeloid Leukemia With t(9;11)(p21.3;q23.3); MLLT3-MLL
Adult Acute Myeloid Leukemia Without Maturation
Adult Acute Myelomonocytic Leukemia
Alkylating Agent-Related Acute Myeloid Leukemia
Secondary Acute Myeloid Leukemia
Interventions
Drug: Cytarabine
Drug: Daunorubicin Hydrochloride
Other: Laboratory Biomarker Analysis
Drug: Decitabine
Other: Pharmacological Study
First Posted Date
2012-06-25
Last Posted Date
2021-06-21
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
178
Registration Number
NCT01627041
Locations
🇺🇸

Lafayette Family Cancer Center-EMMC, Brewer, Maine, United States

🇺🇸

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center, New York, New York, United States

🇺🇸

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

and more 6 locations

T-Cell Replete Haploidentical Donor Hematopoietic Stem Cell Plus Natural Killer (NK) Cell Transplantation in Patients With Hematologic Malignancies Relapsed or Refractory Despite Previous Allogeneic Transplant

Phase 2
Terminated
Conditions
Acute Lymphoblastic Leukemia
Chronic Myelocytic Leukemia
Juvenile Myelomonocytic Leukemia
Hodgkin or Non-Hodgkin Lymphoma
Sarcoma, Myeloid
Myelodysplastic Syndrome
Acute Myelocytic Leukemia
Interventions
First Posted Date
2012-06-18
Last Posted Date
2017-02-20
Lead Sponsor
St. Jude Children's Research Hospital
Target Recruit Count
34
Registration Number
NCT01621477
Locations
🇺🇸

St. Jude Children's Research Hospital, Memphis, Tennessee, United States

Safety and Efficacy Study of Ara-c at 18 gm/m2 Versus 12 gm/m2 for 3 Cycles Each in AML Consolidation

Phase 3
Conditions
Acute Myeloid Leukemia
Interventions
First Posted Date
2012-06-11
Last Posted Date
2012-09-17
Lead Sponsor
All India Institute of Medical Sciences, New Delhi
Target Recruit Count
180
Registration Number
NCT01615757
Locations
🇮🇳

AIIMS, Delhi, India

A Trial of Temsirolimus With Etoposide and Cyclophosphamide in Children With Relapsed Acute Lymphoblastic Leukemia and Non-Hodgkins Lymphoma

Phase 1
Completed
Conditions
Lymphoblastic Leukemia, Acute, Childhood
Peripheral T-cell Lymphoma
Lymphoblastic Lymphoma
Interventions
First Posted Date
2012-06-07
Last Posted Date
2023-07-27
Lead Sponsor
Therapeutic Advances in Childhood Leukemia Consortium
Target Recruit Count
16
Registration Number
NCT01614197
Locations
🇺🇸

Childrens Hospital Los Angeles, Los Angeles, California, United States

🇺🇸

Children's Healthcare of Atlanta, Emory University, Atlanta, Georgia, United States

🇺🇸

Lurie Children's Hospital, Chicago, Illinois, United States

and more 29 locations

Decitabine Followed by Idarubicin and Cytarabine in Treating Patients With Relapsed or Refractory AML and MDS

Phase 2
Terminated
Conditions
Adult Acute Megakaryoblastic Leukemia (M7)
Adult Acute Monoblastic Leukemia (M5a)
Adult Erythroleukemia (M6a)
Adult Pure Erythroid Leukemia (M6b)
Adult Acute Monocytic Leukemia (M5b)
Adult Acute Myeloblastic Leukemia Without Maturation (M1)
Refractory Anemia With Excess Blasts
Adult Acute Myelomonocytic Leukemia (M4)
Recurrent Adult Acute Myeloid Leukemia
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Interventions
First Posted Date
2012-05-30
Last Posted Date
2017-03-31
Lead Sponsor
Fred Hutchinson Cancer Center
Target Recruit Count
7
Registration Number
NCT01607645
Locations
🇺🇸

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

Tosedostat in Combination With Cytarabine or Decitabine in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome

Phase 2
Completed
Conditions
Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
Secondary Myelodysplastic Syndromes
Acute Myeloid Leukemia With Multilineage Dysplasia
Secondary Acute Myeloid Leukemia
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Adult Acute Myeloid Leukemia With Del(5q)
Previously Treated Myelodysplastic Syndromes
Untreated Adult Acute Myeloid Leukemia
de Novo Myelodysplastic Syndromes
Interventions
First Posted Date
2012-03-30
Last Posted Date
2017-02-15
Lead Sponsor
Fred Hutchinson Cancer Center
Target Recruit Count
34
Registration Number
NCT01567059
Locations
🇺🇸

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

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