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

Phase 1 Study of the Dual MDM2/MDMX Inhibitor ALRN-6924 in Pediatric Cancer

Phase 1

Completed

Conditions: Leukemia
Brain Tumor
Solid Tumor
Lymphoma

Interventions: Drug: ALRN-6924
Drug: Cytarabine

First Posted Date: 2018-08-31

Last Posted Date: 2023-08-14

Lead Sponsor: Dana-Farber Cancer Institute

Target Recruit Count: 21

Registration Number: NCT03654716

Locations: 🇺🇸
UCSF Benioff Children's Hospital, San Francisco, California, United States
🇺🇸
Texas Children's Hospital, Baylor College of Medicine, Houston, Texas, United States
🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States

and more 1 locations

Treatment Protocol for Children and Adolescents With Acute Lymphoblastic Leukemia - AIEOP-BFM ALL 2017

Phase 3

Recruiting

Conditions: Acute Lymphoblastic Leukemia, Pediatric

Interventions: Drug: Bortezomib
Drug: Blinatumomab
Drug: Cyclophosphamide
Drug: Cytarabine
Drug: Daunorubicin
Drug: Dexamethasone
Drug: Myocet
Drug: Doxorubicin
Drug: 6-Mercaptopurine
Drug: Etoposide
Drug: Fludarabine Phosphate
Drug: Prednisolone
Drug: Ifosfamide
Drug: Tioguanin
Drug: Pegaspargase
Drug: Methotrexate
Drug: Erwinase
Drug: Vincristine
Drug: Vindesine

First Posted Date: 2018-08-22

Last Posted Date: 2023-11-29

Lead Sponsor: Martin Schrappe

Target Recruit Count: 5000

Registration Number: NCT03643276

Locations: 🇮🇹
AOUC Policlinico Bari, Bari, Italy
🇮🇹
A.O. Papa Giovanni XXIII, Bergamo, Italy
🇮🇹
S.O. Annunziata - A. O. Cosenza, Cosenza, Italy

and more 111 locations

Milademetan Tosylate and Low-Dose Cytarabine With or Without Venetoclax in Treating Participants With Recurrent or Refractory Acute Myeloid Leukemia

Phase 1

Terminated

Conditions: Refractory Acute Myeloid Leukemia
Acute Myeloid Leukemia
Recurrent Acute Myeloid Leukemia

Interventions: Drug: Cytarabine
Drug: Milademetan Tosylate
Drug: Venetoclax

First Posted Date: 2018-08-16

Last Posted Date: 2023-06-15

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 16

Registration Number: NCT03634228

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

Acalabrutinib With Bendamustine / Rituximab Followed by Cytarabine / Rituximab for Untreated Mantle Cell Lymphoma

Phase 2

Active, not recruiting

Conditions: Mantle Cell Lymphoma

Interventions: Drug: Bendamustine
Drug: Rituximab
Drug: Acalabrutinib
Drug: Cytarabine
Procedure: Leukapheresis
Procedure: Peripheral blood
Procedure: Oral rinse
Procedure: Bone marrow collection

First Posted Date: 2018-08-09

Last Posted Date: 2024-02-13

Lead Sponsor: Washington University School of Medicine

Target Recruit Count: 13

Registration Number: NCT03623373

Locations: 🇺🇸
Washington University School of Medicine, Saint Louis, Missouri, United States

A Global Study of Midostaurin in Combination With Chemotherapy to Evaluate Safety, Efficacy and Pharmacokinetics in Newly Diagnosed Pediatric Patients With FLT3 Mutated AML

Phase 2

Recruiting

Conditions: FLT3-mutated Acute Myeloid Leukemia

Interventions: Drug: Midostaurin
Drug: Fludarabine
Drug: Cytarabine
Drug: Daunorubicin or idarubicin
Drug: Mitoxantrone
Drug: Etoposide

First Posted Date: 2018-07-19

Last Posted Date: 2024-04-05

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 23

Registration Number: NCT03591510

Locations: 🇹🇷
Novartis Investigative Site, Istanbul, Turkey

Dexrazoxane Hydrochloride in Preventing Heart-Related Side Effects of Chemotherapy in Participants With Blood Cancers

Phase 2

Recruiting

Conditions: Acute Myeloid Leukemia
Blasts 10 Percent or More of Bone Marrow Nucleated Cells
Myeloproliferative Neoplasm
Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
High Risk Myelodysplastic Syndrome
Myeloid Sarcoma
Philadelphia Chromosome Positive

Interventions: Drug: Cladribine
Drug: Cytarabine
Drug: Dexrazoxane Hydrochloride
Drug: Gemtuzumab Ozogamicin
Drug: Idarubicin

First Posted Date: 2018-07-18

Last Posted Date: 2024-12-17

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 100

Registration Number: NCT03589729

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

A Study of Ponatinib Versus Imatinib in Adults With Acute Lymphoblastic Leukemia

Phase 3

Active, not recruiting

Conditions: Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ALL)

Interventions: Drug: Ponatinib
Drug: Imatinib
Drug: Vincristine
Drug: Dexamethasone
Drug: Cytarabine
Drug: Methotrexate
Drug: Prednisone

First Posted Date: 2018-07-17

Last Posted Date: 2024-10-31

Lead Sponsor: Takeda

Target Recruit Count: 245

Registration Number: NCT03589326

Locations: 🇺🇸
Augusta University Georgia Cancer Center, Augusta, Georgia, United States
🇨🇦
Hopital Charles-LeMoyne, Greenfield Park, Quebec, Canada
🇧🇬
University Multiprofile Hospital for Active Treatment Saint Ivan Rilski, Sofia, Sofiya, Bulgaria

and more 89 locations

A Combination of Vemurafenib, Cytarabine and 2-chlorodeoxyadenosine in Children With LCH and BRAF V600E Mutation

Phase 2

Recruiting

Conditions: Langerhans Cell Histiocytosis

Interventions: Drug: Vemurafenib
Drug: Cytarabine
Drug: 2-chlorodeoxyadenosine

First Posted Date: 2018-07-13

Last Posted Date: 2023-03-16

Lead Sponsor: Federal Research Institute of Pediatric Hematology, Oncology and Immunology

Target Recruit Count: 12

Registration Number: NCT03585686

Locations: 🇷🇺
Dmitry Rogachev National Research Center of Pediatric Hematology, Oncology and Immunology, Moscow, Russian Federation

Venetoclax, Cladribine, Low Dose Cytarabine, and Azacitidine in Treating Patients With Previously Untreated Acute Myeloid Leukemia

Phase 2

Recruiting

Conditions: Acute Myeloid Leukemia

Interventions: Drug: Azacitidine
Drug: Cladribine
Drug: Cytarabine
Drug: Venetoclax

First Posted Date: 2018-07-13

Last Posted Date: 2024-11-13

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 145

Registration Number: NCT03586609

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

Venetoclax, Carmustine, Etoposide, Cytarabine, and Melphalan Before Stem Cell Transplant in Treating Participants With Relapsed or Refractory Non-Hodgkin Lymphoma

Phase 1

Conditions: Recurrent Grade 1 Follicular Lymphoma
Recurrent Grade 2 Follicular Lymphoma
Refractory Follicular Lymphoma
Refractory Marginal Zone Lymphoma
Refractory Non-Hodgkin Lymphoma
Refractory Transformed Indolent Non-Hodgkin Lymphoma
Hematopoietic Cell Transplantation Recipient
Recurrent Diffuse Large B-Cell Lymphoma
Recurrent Grade 3 Follicular Lymphoma
Recurrent Marginal Zone Lymphoma

Interventions: Drug: Carmustine
Drug: Cytarabine
Drug: Etoposide
Procedure: Hematopoietic Cell Transplantation
Drug: Melphalan
Drug: Venetoclax

First Posted Date: 2018-07-11

Last Posted Date: 2021-10-06

Lead Sponsor: Ohio State University Comprehensive Cancer Center

Target Recruit Count: 19

Registration Number: NCT03583424

Locations: 🇺🇸
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States

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