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

Study of Standard Intensive Chemotherapy Versus Intensive Chemotherapy with CPX-351 in Adult Patients with Newly Diagnosed AML and Intermediate- or Adverse Genetics

Phase 3

Recruiting

Conditions: Acute Myeloid Leukemia

Interventions: Drug: CPX-351
Drug: Cytarabine
Drug: Daunorubicin

First Posted Date: 2019-04-01

Last Posted Date: 2024-11-06

Lead Sponsor: University of Ulm

Target Recruit Count: 882

Registration Number: NCT03897127

Locations: 🇩🇪
Klinikum Bremen-Mitte, Bremen, Germany
🇩🇪
Klinikum Darmstadt, Darmstadt, Germany
🇩🇪
St.-Johannes-Hospital, Dortmund, Germany

and more 61 locations

Isatuximab in Combination With Chemotherapy in Pediatric Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia

Phase 2

Terminated

Conditions: Acute Lymphoblastic Leukemia
Acute Myeloid Leukemia

Interventions: Drug: Isatuximab
Drug: Dexamethasone or equivalent
Drug: Fludarabine
Drug: Cytarabine
Drug: Liposomal daunorubicin
Drug: Daunorubicin (nonliposomal)
Drug: Idarubicin
Drug: Filgrastim or equivalent
Drug: Mitoxantrone
Drug: Doxorubicin
Drug: Vincristine
Drug: Pegaspargase (PEG) Asparaginase
Drug: Cyclophosphamide
Drug: Etoposide
Drug: Methotrexate
Drug: L - Asparginase
Drug: Hydroxyurea
Drug: L - Asparaginase (Erwinase)

First Posted Date: 2019-03-04

Last Posted Date: 2024-05-16

Lead Sponsor: Sanofi

Target Recruit Count: 67

Registration Number: NCT03860844

Locations: 🇺🇸
Children's Medical Center of Dallas-Site Number:8400002, Dallas, Texas, United States
🇲🇽
Investigational Site Number :4840001, Monterrey, Nuevo León, Mexico
🇧🇷
Investigational Site Number :0760007, Porto Alegre, Rio Grande Do Sul, Brazil

and more 38 locations

A Study Evaluating the Safety and Efficacy of Idasanutlin in Combination With Cytarabine and Daunorubicin in Patients Newly Diagnosed With Acute Myeloid Leukemia (AML) and the Safety and Efficacy of Idasanutlin in the Maintenance of First AML Complete Remission

Phase 1

Terminated

Conditions: Acute Myeloid Leukemia

Interventions: Drug: Idasanutlin
Drug: Cytarabine
Drug: Daunorubicin
Procedure: Allogeneic Hematopoietic Stem Cell Transplant (Allo-HSCT)

First Posted Date: 2019-02-21

Last Posted Date: 2022-06-21

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 24

Registration Number: NCT03850535

Locations: 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸
Sarah Cannon Research Institute at HealthONE, Denver, Colorado, United States
🇺🇸
UCLA Jonsson Comprehensive Cancer Center, Los Angeles, California, United States

and more 23 locations

DLCL002 Protocol for Patients With High Risk Aggressive B-cell Lymphoma

Phase 2

Recruiting

Conditions: Diffuse Large B Cell Lymphoma
High-grade B-cell Lymphoma
Transformed Lymphoma

Interventions: Drug: Rituximab
Drug: Etoposide
Drug: Vincristine
Drug: Doxorubicin
Drug: Dexamethasone
Drug: Cyclophosphamide
Drug: Lenalidomide
Drug: Cisplatin
Drug: Cytarabine

First Posted Date: 2019-02-12

Last Posted Date: 2022-01-26

Lead Sponsor: Institute of Hematology & Blood Diseases Hospital, China

Target Recruit Count: 118

Registration Number: NCT03837873

Locations: 🇨🇳
the First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China
🇨🇳
Hunan Cancer Hospital, Changsha, Hunan, China
🇨🇳
the First Affiliated Hospital of Jilin University, Changchun, Jilin, China

and more 3 locations

Gilteritinib vs Midostaurin in FLT3 Mutated Acute Myeloid Leukemia

Phase 2

Active, not recruiting

Conditions: Acute Myeloid Leukemia

Interventions: Drug: Gilteritinib
Drug: Midostaurin
Drug: Daunorubicin
Drug: Cytarabine

First Posted Date: 2019-02-11

Last Posted Date: 2024-02-22

Lead Sponsor: PrECOG, LLC.

Target Recruit Count: 181

Registration Number: NCT03836209

Locations: 🇺🇸
UCLA, Los Angeles, California, United States
🇺🇸
University of Rochester Medical Center, Rochester, New York, United States
🇺🇸
HonorHealth Research Institute, Scottsdale, Arizona, United States

and more 41 locations

Venetoclax Combined With Vyxeos (CPX-351) for Participants With Relapsed or Refractory Acute Leukemia

Phase 1

Recruiting

Conditions: Leukemia

Interventions: Drug: Vyxeos
Drug: Venetoclax

First Posted Date: 2019-02-01

Last Posted Date: 2024-01-25

Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Target Recruit Count: 21

Registration Number: NCT03826992

Locations: 🇺🇸
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States

Pevonedistat, Azacitidine, Fludarabine Phosphate, and Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome

Phase 1

Completed

Conditions: Recurrent Acute Myeloid Leukemia
Recurrent Myelodysplastic Syndrome
Refractory Acute Myeloid Leukemia
Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Refractory Myelodysplastic Syndrome

Interventions: Drug: Azacitidine
Drug: Cytarabine
Drug: Fludarabine Phosphate
Drug: Methotrexate
Drug: Pevonedistat
Drug: Therapeutic Hydrocortisone

First Posted Date: 2019-01-23

Last Posted Date: 2024-01-31

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 12

Registration Number: NCT03813147

Locations: 🇺🇸
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
🇺🇸
Saint Jude Children's Research Hospital, Memphis, Tennessee, United States
🇺🇸
Lurie Children's Hospital-Chicago, Chicago, Illinois, United States

and more 16 locations

Low-Intensity Chemotherapy and Venetoclax in Treating Patients with Relapsed or Refractory B- or T-Cell Acute Lymphoblastic Leukemia

Phase 1

Active, not recruiting

Conditions: Recurrent B Acute Lymphoblastic Leukemia
Recurrent T Acute Lymphoblastic Leukemia
Refractory B Acute Lymphoblastic Leukemia
Refractory T Acute Lymphoblastic Leukemia

Interventions: Drug: Cyclophosphamide
Drug: Cytarabine
Drug: Dexamethasone
Drug: Methotrexate
Drug: Nelarabine
Drug: Pegaspargase
Drug: Prednisone
Biological: Rituximab
Drug: Venetoclax
Drug: Vincristine

First Posted Date: 2019-01-17

Last Posted Date: 2025-01-09

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 50

Registration Number: NCT03808610

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

Safety and Efficacy of Quizartinib in Children and Young Adults With Acute Myeloid Leukemia (AML), a Cancer of the Blood

Phase 1

Active, not recruiting

Conditions: Acute Myeloid Leukemia

Interventions: Drug: Quizartinib
Drug: Fludarabine
Drug: Cytarabine
Drug: Intrathecal (IT) triple chemotherapy prophylaxis
Drug: Etoposide

First Posted Date: 2019-01-04

Last Posted Date: 2024-11-07

Lead Sponsor: Daiichi Sankyo

Target Recruit Count: 65

Registration Number: NCT03793478

Locations: 🇺🇸
Loma Linda University Cancer Center, Loma Linda, California, United States
🇺🇸
University of California, San Francisco, San Francisco, California, United States
🇺🇸
Children's Hospital Colorado, Aurora, Colorado, United States

and more 25 locations

Palbociclib in Combination With Chemotherapy in Treating Children With Relapsed Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LL)

Phase 1

Active, not recruiting

Conditions: Lymphoblastic Lymphoma
T-cell Lymphoma
T-cell Leukemia
Acute Leukemia
Recurrent Disease
Leukemia, Lymphocytic

Interventions: Drug: Palbociclib
Drug: Cytarabine
Drug: Methotrexate
Drug: Hydrocortisone
Drug: Doxorubicin
Drug: Prednisolone
Drug: Vincristine
Drug: Pegaspargase
Drug: Prednisone

First Posted Date: 2019-01-03

Last Posted Date: 2024-08-16

Lead Sponsor: Children's Oncology Group

Target Recruit Count: 12

Registration Number: NCT03792256

Locations: 🇺🇸
Children's Healthcare of Atlanta - Egleston, Atlanta, Georgia, United States
🇺🇸
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States
🇺🇸
University of Minnesota/Masonic Cancer Center, Minneapolis, Minnesota, United States

and more 16 locations

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