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

A Study for Improving the Outcome of Childhood Acute Promyeloid Leukemia

Phase 4

Completed

Conditions: Childhood Acute Promyelocytic Leukemia

Interventions: Drug: ATO
Drug: RIF
Drug: ATRA
Drug: mitoxantrone
Drug: Ara-C
Drug: MTX
Drug: 6MP
Other: intrathecal injection

First Posted Date: 2014-07-25

Last Posted Date: 2022-05-10

Lead Sponsor: South China Children's Leukemia Group

Target Recruit Count: 176

Registration Number: NCT02200978

Locations: 🇨🇳
The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, Guangdong, China

Trial of Intensive Chemotherapy With or Without Volasertib in Patients With Newly Diagnosed High-Risk Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML)

Phase 2

Terminated

Conditions: High-risk Myelodysplastic Syndrome (MDS)
Acute Myeloid Leukemia (AML)

Interventions: Drug: Cytarabine
Drug: Volasertib
Drug: Daunorubicin
Drug: Mitoxantrone

First Posted Date: 2014-07-23

Last Posted Date: 2018-02-28

Lead Sponsor: University of Ulm

Target Recruit Count: 6

Registration Number: NCT02198482

Locations: 🇩🇪
Hospital Aschaffenburg, Aschaffenburg, Germany
🇩🇪
Helios Hospital Bad Saarow, Bad Saarow, Germany
🇩🇪
Vivantes Hospital Neukölln, Berlin, Germany

and more 42 locations

Choline Magnesium Trisalicylate and Combination Chemotherapy in Treating Patients With Acute Myeloid Leukemia

Phase 2

Completed

Conditions: Adult Acute Megakaryoblastic Leukemia (M7)
Adult Acute Minimally Differentiated Myeloid Leukemia (M0)
Adult Acute Monoblastic Leukemia (M5a)
Adult Acute Myeloblastic Leukemia Without Maturation (M1)
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Adult Acute Myeloid Leukemia in Remission
Adult Acute Monocytic Leukemia (M5b)
Adult Acute Myeloblastic Leukemia With Maturation (M2)
Adult Acute Myeloid Leukemia With Del(5q)
Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)

Interventions: Drug: choline magnesium trisalicylate
Drug: cytarabine
Drug: idarubicin
Other: laboratory biomarker analysis

First Posted Date: 2014-05-22

Last Posted Date: 2021-08-24

Lead Sponsor: Rutgers, The State University of New Jersey

Target Recruit Count: 27

Registration Number: NCT02144675

Locations: 🇺🇸
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States

Clofarabine, Idarubicin, Cytarabine, Vincristine Sulfate, and Dexamethasone in Treating Patients With Newly Diagnosed or Relapsed Mixed Phenotype Acute Leukemia

Phase 2

Completed

Conditions: Acute Undifferentiated Leukemia
Acute Leukemia of Ambiguous Lineage
Mixed Phenotype Acute Leukemia, B/Myeloid, Not Otherwise Specified
Mixed Phenotype Acute Leukemia
Mixed Phenotype Acute Leukemia, T/Myeloid, Not Otherwise Specified
Acute Bilineal Leukemia
Acute Biphenotypic Leukemia
Recurrent Mixed Phenotype Acute Leukemia

Interventions: Drug: Clofarabine
Drug: Cytarabine
Drug: Dexamethasone
Drug: Idarubicin
Biological: Rituximab
Drug: Sorafenib
Drug: Sorafenib Tosylate
Drug: Vincristine
Drug: Vincristine Sulfate

First Posted Date: 2014-05-12

Last Posted Date: 2024-03-22

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 16

Registration Number: NCT02135874

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

A Pilot Study of Immunotherapy Including Haploidentical NK Cell Infusion Following CD133+ Positively-Selected Autologous Hematopoietic Stem Cells in Children With High Risk Solid Tumors or Lymphomas

Phase 1

Completed

Conditions: Neuroblastoma
Lymphoma
High-risk Tumor

Interventions: Biological: CD133+ selected autologous stem cell infusion
Biological: IL-2
Biological: hu14.18K322A
Drug: Melphalan
Drug: Busulfan
Drug: Bendamustine
Biological: GM-CSF
Drug: Etoposide
Drug: Carboplatin
Device: Haploidentical natural killer cell infusion
Drug: Cytarabine
Biological: G-CSF
Device: CliniMACS
Drug: Etoposide phosphate

First Posted Date: 2014-05-06

Last Posted Date: 2017-12-22

Lead Sponsor: St. Jude Children's Research Hospital

Target Recruit Count: 8

Registration Number: NCT02130869

Locations: 🇺🇸
St. Jude Children's Research Hospital, Memphis, Tennessee, United States

Decitabine and Cytarabine in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia, High Risk Myelodysplastic Syndrome, or Myeloproliferative Neoplasm

Not Applicable

Completed

Conditions: Myeloproliferative Neoplasm
Untreated Adult Acute Myeloid Leukemia
Chronic Myelomonocytic Leukemia-2
Myelodysplastic Syndrome

Interventions: Drug: Cytarabine
Drug: Decitabine
Other: Laboratory Biomarker Analysis

First Posted Date: 2014-04-23

Last Posted Date: 2018-04-13

Lead Sponsor: University of Washington

Target Recruit Count: 12

Registration Number: NCT02121418

Locations: 🇺🇸
EvergreenHealth Medical Center, Kirkland, Washington, United States
🇺🇸
Olympic Medical Center, Port Angeles, Washington, United States
🇺🇸
Skagit Valley Hospital, Mount Vernon, Washington, United States

and more 6 locations

Cladribine, Idarubicin, Cytarabine, and Venetoclax in Treating Patients with Acute Myeloid Leukemia, High-Risk Myelodysplastic Syndrome, or Blastic Phase Chronic Myeloid Leukemia

Phase 2

Recruiting

Conditions: Acute Biphenotypic Leukemia
Acute Myeloid Leukemia
Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Blasts 10 Percent or More of Bone Marrow Nucleated Cells
Blasts 10 Percent or More of Peripheral Blood White Cells
De Novo Myelodysplastic Syndrome
Myelodysplastic Syndrome
Previously Treated Myelodysplastic Syndrome
Recurrent Acute Myeloid Leukemia
Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive

Interventions: Drug: Cladribine
Drug: Cytarabine
Drug: Gilteritinib
Drug: Idarubicin
Other: Laboratory Biomarker Analysis
Drug: Midostaurin
Drug: Venetoclax

First Posted Date: 2014-04-16

Last Posted Date: 2024-12-10

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 508

Registration Number: NCT02115295

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

Combination Chemotherapy With or Without Bortezomib in Treating Younger Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or Stage II-IV T-Cell Lymphoblastic Lymphoma

Phase 3

Active, not recruiting

Conditions: Adult T Acute Lymphoblastic Leukemia
Ann Arbor Stage II Adult Lymphoblastic Lymphoma
Ann Arbor Stage II Childhood Lymphoblastic Lymphoma
Ann Arbor Stage III Adult Lymphoblastic Lymphoma
Ann Arbor Stage III Childhood Lymphoblastic Lymphoma
Ann Arbor Stage IV Adult Lymphoblastic Lymphoma
Ann Arbor Stage IV Childhood Lymphoblastic Lymphoma
Childhood T Acute Lymphoblastic Leukemia

Interventions: Drug: Cyclophosphamide
Drug: Bortezomib
Drug: Cytarabine
Drug: Daunorubicin
Drug: Daunorubicin Hydrochloride
Drug: Dexamethasone
Drug: Doxorubicin
Drug: Doxorubicin Hydrochloride
Drug: Etoposide
Drug: Hydrocortisone Sodium Succinate
Drug: Ifosfamide
Drug: Leucovorin Calcium
Drug: Mercaptopurine
Drug: Methotrexate
Drug: Pegaspargase
Radiation: Radiation Therapy
Drug: Thioguanine
Drug: Vincristine
Drug: Vincristine Sulfate

First Posted Date: 2014-04-14

Last Posted Date: 2025-01-07

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 847

Registration Number: NCT02112916

Locations: 🇺🇸
Covenant Children's Hospital, Lubbock, Texas, United States
🇺🇸
UMC Cancer Center / UMC Health System, Lubbock, Texas, United States
🇦🇺
Monash Medical Center-Clayton Campus, Clayton, Victoria, Australia

and more 209 locations

Ficlatuzumab With High Dose Cytarabine in Relapsed and Refractory AML

Phase 1

Terminated

Conditions: Relapsed Acute Myeloid Leukemia
Refractory Acute Myeloid Leukemia
Acute Myeloid Leukemia

Interventions: Drug: Ficlatuzumab
Drug: Cytarabine

First Posted Date: 2014-04-10

Last Posted Date: 2020-03-24

Lead Sponsor: C. Babis Andreadis

Target Recruit Count: 17

Registration Number: NCT02109627

Locations: 🇺🇸
University of California, San Francisco, San Francisco, California, United States

AML Therapy With Irradiated Allogeneic Cells

Not Applicable

Terminated

Conditions: Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
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 11q23 (MLL) Abnormalities
Adult Erythroleukemia (M6a)
Adult Acute Minimally Differentiated Myeloid Leukemia (M0)
Adult Acute Monocytic Leukemia (M5b)
Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)

Interventions: Drug: fludarabine phosphate
Drug: cytarabine
Biological: donor lymphocytes
Other: laboratory biomarker analysis
Drug: G-CSF

First Posted Date: 2014-04-07

Last Posted Date: 2021-08-24

Lead Sponsor: Rutgers, The State University of New Jersey

Target Recruit Count: 6

Registration Number: NCT02105116

Locations: 🇺🇸
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States

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