Daunorubicin

Generic Name: Daunorubicin

Brand Names: Cerubidine, Vyxeos

Drug Type: Small Molecule

Chemical Formula: C_₂₇H_₂₉NO_₁₀

CAS Number: 20830-81-3

Unique Ingredient Identifier: ZS7284E0ZP

Background: A very toxic anthracycline aminoglycoside antineoplastic isolated from Streptomyces peucetius and others, used in treatment of leukemia and other neoplasms.

Indication: For remission induction in acute nonlymphocytic leukemia (myelogenous, monocytic, erythroid) of adults and for remission induction in acute lymphocytic leukemia of children and adults.

Daunorubicin is indicated in combination with cytarabine 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 Leukaemias (ALL), Acute Myeloid Leukemia With Myelodysplasia-Related Changes, Chronic Phase Chronic Myeloid Leukemia, Ewing's Sarcoma, Lymphoma, Diffuse, Myeloblastic Leukemia, Non-Hodgkin's Lymphoma (NHL), Treatment-Related Acute Myeloid Leukemia, Wilms' tumor

Associated Therapies: -

Clinical Trials

A Study of RO5503781 as a Single Agent or in Combination With Cytarabine in Participants With Acute Myelogenous Leukemia

Phase 1

Completed

Conditions: Myelogenous Leukemia, Acute

Interventions: Drug: RO5503781 MBP
Drug: RO5503781 SDP
Drug: Idarubicin
Drug: Daunorubicin
Drug: Cytarabine

First Posted Date: 2013-01-23

Last Posted Date: 2017-01-25

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 122

Registration Number: NCT01773408

Locations: 🇺🇸
USC Norris Cancer Center, Los Angeles, California, United States
🇺🇸
Cancer Therapy & Research Ctr; Dept Institute for Drug Development, San Antonio, Texas, United States
🇨🇦
McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology, Montreal, Quebec, Canada

and more 9 locations

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

A Study To Evaluate PF-04449913 With Chemotherapy In Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome

Phase 2

Completed

Conditions: Acute Myeloid Leukemia

Interventions: Drug: PF-04449913
Drug: Low dose ARA-C (LDAC)
Drug: Daunorubicin
Drug: Decitabine
Drug: Cytarabine

First Posted Date: 2012-03-07

Last Posted Date: 2020-03-03

Lead Sponsor: Pfizer

Target Recruit Count: 255

Registration Number: NCT01546038

Locations: 🇺🇸
Keck Hospital of USC, Los Angeles, California, United States
🇺🇸
University of Kansas Cancer Center and Medical Pavilion, Westwood, Kansas, United States
🇺🇸
LAC & USC Medical Center, Los Angeles, California, United States

and more 75 locations

Protocol in Acute Myeloid Leukemia With FLT3-ITD

Phase 2

Completed

Conditions: Acute Myeloid Leukemia

Interventions: Drug: Midostaurin
Drug: Cytarabine
Drug: Daunorubicin

First Posted Date: 2011-11-22

Last Posted Date: 2020-06-04

Lead Sponsor: University of Ulm

Target Recruit Count: 451

Registration Number: NCT01477606

Locations: 🇦🇹
Krankenhaus der Elisabethinen Linz GmbH, Linz, Austria
🇩🇪
Helios Klinikum Bad Saarow, Bad Saarow, Germany
🇩🇪
Städtisches Klinikum Braunschweig gGmbH, Braunschweig, Germany

and more 52 locations

Phase I Dose Finding and Proof-of-concept Study of Panobinostat With Standard Dose Cytarabine and Daunorubicin for Untreated Acute Myeloid Leukemia or Advanced Myelodysplastic Syndrome

Phase 1

Completed

Conditions: Acute Myeloid Leukemia
Advanced Myelodysplastic Syndrome

Interventions: Drug: Panobinostat
Drug: Cytarabine
Drug: Daunorubicin

First Posted Date: 2011-11-01

Last Posted Date: 2019-04-22

Lead Sponsor: University of California, San Francisco

Target Recruit Count: 29

Registration Number: NCT01463046

Locations: 🇺🇸
UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California, United States

NHL16: Study For Newly Diagnosed Patients With Acute Lymphoblastic Lymphoma

Phase 2

Completed

Conditions: Lymphoblastic Lymphoma

Interventions: Drug: Prednisone
Drug: Vincristine
Drug: Daunorubicin
Drug: PEG-asparaginase
Drug: Erwinia asparaginase
Drug: Doxorubicin
Drug: Cyclophosphamide
Drug: Cytarabine
Drug: Thioguanine
Drug: Clofarabine
Drug: Methotrexate
Drug: Mercaptopurine
Drug: Dexamethasone
Drug: Hydrocortisone
Drug: Etoposide

First Posted Date: 2011-10-13

Last Posted Date: 2022-06-28

Lead Sponsor: St. Jude Children's Research Hospital

Target Recruit Count: 23

Registration Number: NCT01451515

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

A Study to Assess AC220 Given in Combination With Induction and Consolidation Therapy in Newly Diagnosed Acute Myeloid Leukemia (AML)

Phase 1

Completed

Conditions: Leukemia, Myeloid, Acute

Interventions: Drug: AC220
Drug: daunorubicin
Drug: cytarabine

First Posted Date: 2011-07-11

Last Posted Date: 2019-02-12

Lead Sponsor: Daiichi Sankyo

Target Recruit Count: 19

Registration Number: NCT01390337

Locations: 🇺🇸
Mayo Clinic Jacksonville, Jacksonville, Florida, United States
🇺🇸
Northwestern University, Chicago, Illinois, United States
🇺🇸
M.D. Anderson Cancer Center, Houston, Texas, United States

and more 2 locations

Bortezomib and Sorafenib Tosylate in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia

Phase 3

Active, not recruiting

Conditions: Acute Myeloid Leukemia
Myeloid Sarcoma
Leukemia Cutis
Myeloid Neoplasm

Interventions: Drug: Asparaginase
Drug: Daunorubicin Hydrochloride
Drug: Cytarabine
Drug: Bortezomib
Other: Laboratory Biomarker Analysis
Drug: Etoposide
Drug: Mitoxantrone Hydrochloride
Other: Pharmacological Study
Other: Quality-of-Life Assessment
Other: Questionnaire Administration
Drug: Sorafenib Tosylate

First Posted Date: 2011-06-13

Last Posted Date: 2024-10-22

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 1645

Registration Number: NCT01371981

Locations: 🇺🇸
AdventHealth Orlando, Orlando, Florida, United States
🇺🇸
Blank Children's Hospital, Des Moines, Iowa, United States
🇺🇸
Albany Medical Center, Albany, New York, United States

and more 217 locations

Alvocidib, Cytarabine, and Mitoxantrone Hydrochloride or Cytarabine and Daunorubicin Hydrochloride in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia

Phase 2

Completed

Conditions: Adult Acute Minimally Differentiated Myeloid Leukemia (M0)
Adult Acute Monoblastic Leukemia (M5a)
Adult Erythroleukemia (M6a)
Adult Pure Erythroid Leukemia (M6b)
Secondary Acute Myeloid Leukemia
Untreated Adult Acute Myeloid Leukemia
Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome
Adult Acute Monocytic Leukemia (M5b)
Adult Acute Myeloblastic Leukemia With Maturation (M2)
Adult Acute Myeloblastic Leukemia Without Maturation (M1)

Interventions: Drug: daunorubicin hydrochloride
Drug: alvocidib
Drug: mitoxantrone hydrochloride
Drug: cytarabine

First Posted Date: 2011-05-09

Last Posted Date: 2017-07-31

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 172

Registration Number: NCT01349972

Locations: 🇺🇸
Blood and Marrow Transplant Group of Georgia, Atlanta, Georgia, United States
🇺🇸
Mayo Clinic Scottsdale-Phoenix, Scottsdale, Arizona, United States
🇺🇸
Johns Hopkins University/Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, United States

and more 8 locations

Dasatinib Followed by Stem Cell Transplant in Treating Older Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

Phase 2

Completed

Conditions: Acute Lymphoblastic Leukemia
Adult B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1

Interventions: Biological: Alemtuzumab
Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
Procedure: Autologous Hematopoietic Stem Cell Transplantation
Drug: Cyclophosphamide
Drug: Cytarabine
Drug: Dasatinib
Drug: Daunorubicin Hydrochloride
Drug: Dexamethasone
Drug: Etoposide Phosphate
Biological: Filgrastim
Drug: Fludarabine Phosphate
Procedure: In Vitro-Treated Peripheral Blood Stem Cell Transplantation
Other: Laboratory Biomarker Analysis
Drug: Leucovorin Calcium
Drug: Melphalan
Drug: Mercaptopurine
Drug: Methotrexate
Biological: Pegfilgrastim
Other: Pharmacological Study
Drug: Tacrolimus
Drug: Vincristine Sulfate

First Posted Date: 2010-12-08

Last Posted Date: 2023-04-04

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 66

Registration Number: NCT01256398

Locations: 🇺🇸
Rocky Mountain Cancer Centers-Longmont, Longmont, Colorado, United States
🇺🇸
Fort Wayne Medical Oncology and Hematology Inc-Parkview, Fort Wayne, Indiana, United States
🇺🇸
Longmont United Hospital, Longmont, Colorado, United States

and more 98 locations

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