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

CD19-specific T Cell Infusion in Patients With B-Lineage Lymphoid Malignancies

Phase 1

Completed

Conditions: B-cell Lymphoma
Lymphoma

Interventions: Procedure: Leukapheresis
Procedure: Stem Cell Transplant
Procedure: CD19-specific T Cell Infusion
Drug: Carmustine
Drug: IL-2
Drug: Etoposide
Drug: Melphalan
Drug: Cytarabine

First Posted Date: 2009-08-31

Last Posted Date: 2023-12-19

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 34

Registration Number: NCT00968760

Locations: 🇺🇸
University of Texas MD Anderson Cancer Center, Houston, Texas, United States

S0910 Epratuzumab, Cytarabine, and Clofarabine in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia

Phase 2

Completed

Conditions: Leukemia

Interventions: Biological: epratuzumab
Drug: clofarabine
Drug: cytarabine
Other: laboratory biomarker analysis

First Posted Date: 2009-07-24

Last Posted Date: 2017-11-06

Lead Sponsor: SWOG Cancer Research Network

Target Recruit Count: 35

Registration Number: NCT00945815

Locations: 🇺🇸
Wayne Hospital, Greenville, Ohio, United States
🇺🇸
Glacier Oncology, PLLC, Kalispell, Montana, United States
🇺🇸
Charles F. Kettering Memorial Hospital, Kettering, Ohio, United States

and more 78 locations

T2007-002 Clofarabine, Etoposide, Cyclophosphamide in Relapsed Acute Myelogenous Leukemia (AML)

Phase 2

Terminated

Conditions: Relapsed Acute Myelogenous Leukemia

Interventions: Drug: Clofarabine
Drug: Etoposide
Drug: Cyclophosphamide
Drug: Filgrastim
Drug: Cytarabine

First Posted Date: 2009-07-15

Last Posted Date: 2020-02-19

Lead Sponsor: Therapeutic Advances in Childhood Leukemia Consortium

Target Recruit Count: 6

Registration Number: NCT00939653

Locations: 🇺🇸
University of Miami Cancer Center, Miami, Florida, United States
🇺🇸
Childrens Hospital Los Angeles, Los Angeles, California, United States
🇺🇸
Children's Memorial, Chicago, Illinois, United States

and more 1 locations

Erwinase for Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) (IND 104224)

Phase 1

Terminated

Conditions: Relapsed Acute Lymphoblastic Leukemia
Allergy to PEG e.Coli Asparaginase
Allergy to Native e.Coli Asparaginase

Interventions: Drug: Erwinase
Drug: Vincristine
Drug: Dexamethasone
Drug: Doxorubicin
Drug: Cytarabine
Drug: Methotrexate
Drug: Triple Intrathecal Therapy
Drug: Dexrazoxane

First Posted Date: 2009-06-25

Last Posted Date: 2019-02-19

Lead Sponsor: Therapeutic Advances in Childhood Leukemia Consortium

Target Recruit Count: 1

Registration Number: NCT00928200

Locations: 🇺🇸
Childrens Hospital Los Angeles, Los Angeles, California, United States

Three Different Therapy Regimens in Treating Patients With Previously Untreated Hodgkin Lymphoma

Phase 3

Terminated

Conditions: Lymphoma

Interventions: Biological: bleomycin sulfate
Drug: ABVD regimen
Drug: cisplatin
Drug: carmustine
Drug: cytarabine
Drug: dacarbazine
Drug: dexamethasone
Drug: doxorubicin hydrochloride
Drug: etoposide
Drug: gemcitabine hydrochloride
Drug: vincristine sulfate
Drug: ifosfamide
Drug: vindesine
Drug: melphalan
Drug: methylprednisolone
Drug: mitoguazone
Drug: vinorelbine tartrate
Procedure: allogeneic hematopoietic stem cell transplantation
Procedure: autologous hematopoietic stem cell transplantation

First Posted Date: 2009-06-15

Last Posted Date: 2016-09-16

Lead Sponsor: French Innovative Leukemia Organisation

Target Recruit Count: 442

Registration Number: NCT00920153

Locations: 🇫🇷
FILO French Innovative Leukemia Organization, Tours Cedex, France

Carmustine, Etoposide, Cytarabine, Melphalan, and Alemtuzumab Followed by Donor Stem Cell Transplant in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma

Phase 2

Conditions: Lymphoma

First Posted Date: 2009-05-25

Last Posted Date: 2013-08-02

Lead Sponsor: Cancer Research UK

Target Recruit Count: 47

Registration Number: NCT00908180

Sorafenib in Combination With Cytarabine and Clofarabine in Patients With Refractory or Relapsed Hematologic Malignancies

Phase 1

Completed

Conditions: Acute Myeloid Leukemia
Myelodysplastic Syndrome
Infantile Leukemia (Both AML and ALL)
Biphenotypic Leukemia
Myelodysplastic/Myeloproliferative Neoplasms

Interventions: Drug: Sorafenib
Drug: Cytarabine
Drug: Clofarabine

First Posted Date: 2009-05-25

Last Posted Date: 2018-01-12

Lead Sponsor: St. Jude Children's Research Hospital

Target Recruit Count: 44

Registration Number: NCT00908167

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

Study of SCH 900776 (MK-8776) With and Without Cytarabine in Participants With Acute Leukemias (P05247)

Phase 1

Terminated

Conditions: Myelogenous Leukemia, Acute
Leukemia, Lymphoblastic, Acute, Philadelphia-Positive
Leukemia, Lymphocytic, Acute
Myelogenous Leukemia, Chronic, Aggressive Phase

Interventions: Drug: MK-8776
Drug: Cytarabine

First Posted Date: 2009-05-22

Last Posted Date: 2018-08-27

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 24

Registration Number: NCT00907517

Chemosensitization With Plerixafor Plus G-CSF in Acute Myeloid Leukemia

Phase 1

Completed

Conditions: Leukemia, Myeloid, Acute

Interventions: Drug: G-CSF
Drug: Plerixafor
Drug: Mitoxantrone
Drug: Etoposide
Drug: Cytarabine

First Posted Date: 2009-05-21

Last Posted Date: 2017-04-04

Lead Sponsor: Washington University School of Medicine

Target Recruit Count: 39

Registration Number: NCT00906945

Locations: 🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
Washington University, St. Louis, Missouri, United States
🇺🇸
MD Anderson Cancer Center, Houston, Texas, United States

Study of Augmented Hyper-CVAD in Acute Lymphoblastic Leukemia Salvage

Phase 2

Completed

Conditions: Acute Lymphoblastic Leukemia

Interventions: Drug: Cyclophosphamide (CTX)
Drug: Vincristine
Drug: Doxorubicin
Drug: Decadron
Drug: G-CSF
Drug: Methotrexate (MTX)
Drug: Ara-C
Drug: Pegaspargase

First Posted Date: 2009-04-30

Last Posted Date: 2012-02-20

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 90

Registration Number: NCT00890656

Locations: 🇺🇸
UT MD Anderson Cancer Center, Houston, Texas, United States

Drug Development Updates

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