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Cerubidine

(Daunorubicin)

ApprovedSmall molecule

HHikma Pharmaceuticals LLC

Daunorubicin is a chemotherapy drug used to treat certain types of blood cancers, particularly leukemia. It works by damaging cancer cell DNA to stop them from growing and dividing.[2] Cerubidine is currently approved and in use across 23 indications[4].[1]

Cerubidine is one of 327 small molecule programs targeting Childhood Acute Lymphoblastic Leukemia. It is currently in Approved.

23

Indications

122

Total Trials

46

Active Trials

326

Competitors

3

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Childhood Acute Lymphoblastic LeukemiaApproved

Non-Hodgkins LymphomaApproved

T-Cell Acute Lymphoblastic LeukemiaWithdrawn

Lymphoblastic LymphomaRecruiting

Chronic Hepatitis B Virus InfectionApproved

Acute Promyelocytic LeukemiaActive, not recruiting

Adult Acute Myeloid LeukemiaActive, not recruiting

Hematopoietic and Lymphoid Cell NeoplasmApproved

Acute Lymphoblastic LeukemiaCompleted

Acute Myeloid LeukemiaActive, not recruiting

Childhood Acute Lymphoblastic LeukemiaApproved

Approved

Non-Hodgkins LymphomaApproved

Approved

T-Cell Acute Lymphoblastic LeukemiaPhase 2

Withdrawn

Lymphoblastic LymphomaApproved

Recruiting

Chronic Hepatitis B Virus InfectionApproved

Approved

Acute Promyelocytic LeukemiaApproved

Active, not recruiting

Adult Acute Myeloid LeukemiaPreclinical

Active, not recruiting

Hematopoietic and Lymphoid Cell NeoplasmApproved

Approved

Acute Lymphoblastic LeukemiaApproved

Completed

Acute Myeloid LeukemiaPhase 3

Active, not recruiting

Showing 10 of 23 indications

Competition

Competitive Landscape

235 competitors in Acute Myeloid Leukemia

#DrugCompanyPhaseTrials

Cerubidine

HHikma Pharmaceuticals LLC

Novantrone

Fludara

Vepesid

Cerubidine

HHikma Pharmaceuticals LLC

Mylotarg

WWyeth-Lederle Vaccines

Vanflyta

Neupogen

EEastern Cooperative Oncology Group

Nexavar

Cellcept

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 1Active, not recruiting

Acute Myeloid Leukemia

NCT03709758

Phase 1Recruiting

Acute Myeloid Leukemia

NCT04659616

Q1 2027

Phase 3Active, not recruiting

Acute Lymphoblastic Leukemia

NCT02003222

Phase 3Recruiting

Newly Diagnosed

NCT06361329

Q2 2027

Phase 2Recruiting

Elderly Patients

NCT06744556

Phase 3Active, not recruiting

Newly Diagnosed

NCT03897127

Clinical

Trials by Indication[1]

Acute Myeloid Leukemia32 trials

Ph I Study of Alvocidib and Cytarabine/Daunorubicin (7+3) in Patients With Newly Diagnosed Acute Myeloid Leukemia (AML).

Completed· Sumitomo Pharma America, Inc. logo

Sumitomo Pharma America, Inc.·Phase 1·NCT03298984·32 enrolled

Entospletinib Monotherapy and in Combination With Chemotherapy in Adults With Acute Myeloid Leukemia (AML)

Terminated· Gilead logo

Gilead·Phase 1/2·NCT02343939·148 enrolled

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

Terminated· Roche logo

Roche·Phase 1/2·NCT03850535·24 enrolled

Show 29 more trials

Pinometostat With Standard Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia and MLL Gene Rearrangement

Terminated·NNational Cancer Institute (NCI)·Phase 1/2·NCT03724084·6 enrolled

Protocol in Acute Myeloid Leukemia With FLT3-ITD

Completed·UUniversity of Ulm·Phase 2·NCT01477606·451 enrolled

Study of Quizartinib in Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)

Completed· Daiichi Sankyo logo

Daiichi Sankyo·Phase 1·NCT02834390·7 enrolled

A Safety and Tolerability Study of Crenolanib in Combination With Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia Patients With FLT3 Mutations

Completed·AArog Pharmaceuticals, Inc.·Phase 2·NCT02283177·44 enrolled

A Study of ASP2215 in Combination With Induction and Consolidation Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia

Completed· Astellas logo

Astellas·Phase 1·NCT02236013·80 enrolled

A Study Of PF-06747143, As Single Agent Or In Combination With Standard Chemotherapy In Adult Patients With Acute Myeloid Leukemia

Terminated· Pfizer logo

Pfizer·Phase 1·NCT02954653·8 enrolled

Biology and Treatment Strategy of AML in Its Subgroups: Multicenter Randomized Trial by the German Acute Myeloid Leukemia Cooperative Group (AMLCG)

Completed·UUniversity Hospital Muenster·Phase 3·NCT00266136·3,500 enrolled

Clofarabine Plus Cytarabine Versus Conventional Induction Therapy And A Study Of NK Cell Transplantation In Newly Diagnosed Acute Myeloid Leukemia

Completed·SSt. Jude Children's Research Hospital·Phase 3·NCT00703820·324 enrolled

Selinexor in Combination With HAD or CAG Rregimens in Relapsed or Refractory Acute Myeloid Leukemia

Recruiting·SShanxi Bethune Hospital·Phase 3·NCT05726110·50 enrolled

Safety Study of AG-120 or AG-221 in Combination With Induction and Consolidation Therapy in Participants With Newly Diagnosed Acute Myeloid Leukemia (AML) With an IDH1 and/or IDH2 Mutation

Active, not recruiting· Institut de Recherches Internationales Servier logo

Institut de Recherches Internationales Servier·Phase 1·NCT02632708·153 enrolled

Zosuquidar in Combination With Daunorubicin and Cytarabine in Patients Ages 55-75 With Newly Diagnosed Acute Myeloid Leukemia (AML)

Completed·KKanisa Pharmaceuticals·Phase 1/2·NCT00129168·100 enrolled

Clofarabine or Daunorubicin Hydrochloride and Cytarabine Followed By Decitabine or Observation in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia

Completed·EECOG-ACRIN Cancer Research Group·Phase 3·NCT02085408·727 enrolled

Study of Magrolimab in Combination With Azacitidine Versus Physician's Choice of Venetoclax in Combination With Azacitidine or Intensive Chemotherapy in Patients With TP53 Mutant Acute Myeloid Leukemia That Have Not Been Treated

Terminated· Gilead logo

Gilead·Phase 3·NCT04778397·258 enrolled

Dasatinib (Sprycel™) in Patients With Newly Diagnosed Core Binding Factor (CBF) Acute Myeloid Leukemia (AML)

Completed·UUniversity of Ulm·Phase 1/2·NCT00850382·89 enrolled

A Trial of Epigenetic Priming in Patients With Newly Diagnosed Acute Myeloid Leukemia

Active, not recruiting·SSt. Jude Children's Research Hospital·Phase 2·NCT03164057·206 enrolled

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

Completed· Daiichi Sankyo logo

Daiichi Sankyo·Phase 1·NCT01390337·19 enrolled

Daunorubicin and Cytarabine With or Without Uproleselan in Treating Older Adult Patients With Acute Myeloid Leukemia Receiving Intensive Induction Chemotherapy

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2/3·NCT03701308·267 enrolled

Clinical Evaluation of ASTX727 in Combination With Venetoclax All-Oral Therapy vs Standard of Care Cytarabine and Anthracycline Induction Chemotherapy for Younger FLT3WT Patients With ELN High- Risk Acute Myeloid Leukemia

Active, not recruiting·NNational Cancer Institute (NCI)·Preclinical·NCT04817241·5 enrolled

Master Screening and Reassessment Protocol (MSRP) for the NCI MyeloMATCH Clinical Trials

Recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT05564390·2,000 enrolled

Phase 1b Study of Venetoclax in Combination With Intensive Induction and Consolidation Chemotherapy in Treatment Naïve Subjects With Acute Myelogenous Leukemia

Active, not recruiting·DDana-Farber Cancer Institute·Phase 1·NCT03709758·50 enrolled

A Phase II Randomized Clinical Trial of Venetoclax Combined With FLAG IDA Induction and Consolidation Compared to Standard of Care for Newly Diagnosed Patients With Acute Myeloid Leukemia

Recruiting·OOHSU Knight Cancer Institute·Phase 2·NCT07228273·102 enrolled

Phase 2 Study of Venetoclax-containing Therapy in Combination With HLA-mismatched Mobilized Peripheral Blood Mononuclear Cell Infusion for Newly Diagnosed Acute Myeloid Leukemia

Recruiting·BBeijing 302 Hospital·Phase 2·NCT07078591·50 enrolled

A Phase II Randomized Study of Induction Therapy Comparing Cytarabine, Daunorubicin, and Quizartinib vs Azacitidine, Venetoclax, and Quizartinib in FLT3-ITD Mutant Acute Myeloid Leukemia: A MyeloMATCH Substudy

Not yet recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT07862517·122 enrolled

A Phase II/III Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of BL-M11D1 for Injection in Combination With Cytarabine + Daunorubicin or Venetoclax + Azacitidine in Patients With Acute Myeloid Leukemia

Recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Preclinical·NCT07255872·216 enrolled

Study of the Efficacy and Safety of Venetoclax Plus Azacytidine Versus Daunorubicin Plus Cytarabine in Adult Acute Myeloid Leukemia (AML) Patients With Adverse Risk Features

Recruiting·TThe First Affiliated Hospital of Soochow University·Preclinical·NCT05939180·116 enrolled

A Phase 1b Study of Menin Inhibitor SNDX-5613 in Combination With Daunorubicin and Cytarabine in Newly Diagnosed Patients With Acute Myeloid Leukemia and NPM1 Mutated/FLT3 Wildtype or MLL/KMT2A Rearranged or NUP98 Alterations Disease

Recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT05886049·38 enrolled

Randomized Trial of Gilteritinib vs Midostaurin in FLT3 Mutated Acute Myeloid Leukemia (AML)

Completed·PPrECOG, LLC.·Phase 2·NCT03836209·181 enrolled

A Multicenter, Phase 1, Open-Label Study of the FGFR Inhibitor Pemigatinib (INCB054828) Administered After Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia (AML) With Adverse or Intermediate Risk Cytogenetics

Recruiting·OOHSU Knight Cancer Institute·Phase 1·NCT04659616·32 enrolled

A Trial of Atovaquone (Mepron®) Combined With Conventional Chemotherapy for de Novo Acute Myeloid Leukemia (AML) in Children, Adolescents, and Young Adults (ATACC AML)

Completed·BBaylor College of Medicine·Phase 1·NCT03568994·26 enrolled

Acute Lymphoblastic Leukemia27 trials

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

Terminated· Sanofi logo

Sanofi·Phase 2·NCT03860844·67 enrolled

Azacitidine and Combination Chemotherapy in Treating Infants With Acute Lymphoblastic Leukemia and KMT2A Gene Rearrangement

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT02828358·78 enrolled

Study of Carfilzomib in Combination With Induction Chemotherapy in Children With Relapsed or Refractory Acute Lymphoblastic Leukemia

Completed· Amgen logo

Amgen·Phase 1·NCT02303821·141 enrolled

Show 24 more trials

Pethema LAL-RI/2008: Treatment for Patients With Standard Risk Acute Lymphoblastic Leukemia

Completed·PPETHEMA Foundation·Phase 4·NCT02036489·107 enrolled

Ponatinib With Chemotherapy for Young Adults Ph Positive Acute Lymphoblastic Leukemia

Unknown status·PPETHEMA Foundation·Phase 2·NCT02776605·30 enrolled

German Multicenter Trial for Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Adults (07/2003)

Completed·GGoethe University·Phase 4·NCT00198991·1,883 enrolled

LAL-Ph-2000: Treatment of Acute Lymphoblastic Leukemia Chromosome Philadelphia Positive

Completed·PPETHEMA Foundation·Phase 4·NCT00526305·100 enrolled

Malaysia-Singapore Acute Lymphoblastic Leukemia 2010 Study

Unknown status·NNational University Hospital, Singapore·Phase 4·NCT02894645·500 enrolled

Combination Chemotherapy Based on Risk of Relapse in Treating Young Patients With Acute Lymphoblastic Leukemia

Completed·AAssociazione Italiana Ematologia Oncologia Pediatrica·Phase 3·NCT00613457·2,039 enrolled

PETHEMA LAL-RI/96: Treatment for Patients With Standard Risk Acute Lymphoblastic Leukemia

Completed·PPETHEMA Foundation·Phase 4·NCT00494897·374 enrolled

Trial for Treatment of Adult Patients With Standard Risk Acute Lymphoblastic Leukemia With Chemotherapy and Rituximab

Completed·JJohann Wolfgang Goethe University Hospital·Phase 4·NCT00199004·60 enrolled

Dasatinib Combined With Chemotherapy in Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia

Completed·IInstitute of Hematology & Blood Diseases Hospital, China·Phase 2·NCT02523976·30 enrolled

Pediatric-inspired Regimen Combined With Venetoclax for Adolescent and Adult Patients With de Novo Philadelphia Chromosome-Negative Acute Lymphoblastic Leukemia

Recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·Phase 2·NCT05660473·100 enrolled

Study of Imatinib-Combined Chemotherapy for BCR-ABL-Positive Acute Lymphoblastic Leukemia (ALL)

Completed·JJapan Adult Leukemia Study Group·Phase 2·NCT00130195·100 enrolled

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

Recruiting·MMartin Schrappe·Phase 3·NCT03643276·5,000 enrolled

German Multicenter Trial for Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Adults (06/99)

Completed·GGoethe University·Phase 4·NCT00199056·225 enrolled

Modified MRCUKALLⅫ/ECOGE2993 Regimen for ALL

Unknown status·SSun Yat-sen University·Phase 2·NCT02660762·100 enrolled

Augmented Berlin-Frankfurt-Munster Therapy Plus Ofatumumab for Young Adults With Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

Terminated·MM.D. Anderson Cancer Center·Phase 2·NCT02419469·1 enrolled

S0333 Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

Completed·SSWOG Cancer Research Network·Phase 2·NCT00109837·79 enrolled

Total Therapy XVII for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia and Lymphoma

Active, not recruiting·SSt. Jude Children's Research Hospital·Phase 2/3·NCT03117751·790 enrolled

ASIA Down Syndrome Acute Lymphoblastic Leukemia 2016

Recruiting·NNational Hospital Organization Nagoya Medical Center·Phase 2·NCT03286634·60 enrolled

Augmented Berlin-Frankfurt-Munster (BFM) Therapy for Adolescent/Young Adults With Acute Lymphoblastic Leukemia or Acute Lymphoblastic Lymphoma

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT00866749·120 enrolled

LAL-AR-N-2005:Study Treatment for Children High Risk Acute Lymphoblastic Leukemia

Completed·PPETHEMA Foundation·Phase 4·NCT00526409·40 enrolled

Optimization of Therapy in Adult Patients With Newly Diagnosed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma by Individualised, Targeted and Intensified Treatment

Completed·GGoethe University·Phase 3·NCT02881086·1,023 enrolled

A Phase III Randomized Trial of Blinatumomab for Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic Leukemia in Adults

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 3·NCT02003222·488 enrolled

SJALL23H: Combination Antigen-Directed Induction Therapy for Newly Diagnosed Patients With B-Cell Precursor Acute Lymphoblastic Leukemia and Lymphoma

Recruiting·SSt. Jude Children's Research Hospital·Phase 2·NCT06533748·128 enrolled

INITIALL: Identification of Necessary Information for Treatment Induction in Newly Diagnosed Acute Lymphoblastic Leukemia/Lymphoma

Recruiting·SSt. Jude Children's Research Hospital·Approved·NCT06289673·850 enrolled

Leukemia5 trials

Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Patients With AML Leukemia

Completed·EEastern Cooperative Oncology Group·Phase 3·NCT00049517·657 enrolled

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

Completed· Roche logo

Roche·Phase 1·NCT01773408·122 enrolled

Combination Chemotherapy Plus PSC 833 Followed by Interleukin-2 in Treating Patients With Acute Myelogenous Leukemia

Completed·NNational Cancer Institute (NCI)·Phase 1/2·NCT00002925·410 enrolled

Show 2 more trials

A Phase III Randomized, Double-Blind Study of Induction (Daunorubicin/Cytarabine) and Consolidation (High-Dose Cytarabine) Chemotherapy + Midostaurin (PKC412) (IND #101261) or Placebo in Newly Diagnosed Patients < 60 Years of Age With FLT3 Mutated Acute Myeloid Leukemia (AML)

Completed·AAlliance for Clinical Trials in Oncology·Phase 3·NCT00651261·717 enrolled

A Novel "Pediatric-Inspired" Regimen With Reduced Myelosuppressive Drugs for Adults (Aged 18-60) With Newly Diagnosed Ph Negative Acute Lymphoblastic Leukemia

Active, not recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT01920737·39 enrolled

Newly Diagnosed5 trials

CHIP-AML22/Quizartinib: Quizartinib + Chemotherapy in Newly Diagnosed Pediatric FLT3-ITD+ and NPM1wt AML Patients

Recruiting·PPrincess Maxima Center for Pediatric Oncology·Phase 2·NCT06262438·60 enrolled

First-line Dasatinib Plus Conventional Chemotherapy in Adults With Newly Diagnosed Ph-Positive ALL

Completed·TThe Catholic University of Korea·Phase 2·NCT01004497·51 enrolled

Trial of CPX-351 in Newly Diagnosed Elderly AML Patients

Completed· Jazz Pharmaceuticals logo

Jazz Pharmaceuticals·Phase 2·NCT00788892·126 enrolled

Show 2 more trials

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

Active, not recruiting·UUniversity of Ulm·Phase 3·NCT03897127·882 enrolled

Comparing the Efficacy of VHAG and Traditional Chemotherapy Regimens in Newly Diagnosed ETP-ALL

Recruiting·FFirst Affiliated Hospital of Zhejiang University·Phase 3·NCT06361329·81 enrolled

AML4 trials

AML Patients Bearing FLT3 Mutations Based on Peripheral Blast Clearance

Unknown status·GGruppo Italiano Malattie EMatologiche dell'Adulto·Phase 3·NCT04174612·172 enrolled

Epacadostat, Idarubicin and Cytarabine (EIC) in AML

Withdrawn·IInsel Gruppe AG, University Hospital Bern·Phase 1·NCT03444649

Multicenter, Platform-type Clinical Study of Refractory/Recurrent Acute Myeloid Leukemia

Recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·Preclinical·NCT06265545·458 enrolled

Show 1 more trial

Anthracycline-based Standard-dose vs Intermediate-dose Cytarabine Induction in the Treatment of Acute Myeloid Leukemia With RUNX1-RUNX1T1: a Prospective, Randomized, Controlled Phase III Clinical Trial

Recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·Phase 3·NCT06744504·284 enrolled

34 more indications

Myelodysplastic Syndrome3 trials

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

Completed·UUniversity of California, San Francisco·Phase 1·NCT01463046·29 enrolled

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

Terminated·UUniversity of Ulm·Phase 2·NCT02198482·6 enrolled

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

Completed· Pfizer logo

Pfizer·Phase 2·NCT01546038·255 enrolled

Lymphoblastic Lymphoma3 trials

NHL16: Study For Newly Diagnosed Patients With Acute Lymphoblastic Lymphoma

Completed·SSt. Jude Children's Research Hospital·Phase 2·NCT01451515·23 enrolled

German Multicenter Trial for the Treatment of Newly Diagnosed T-lymphoblastic Lymphoma in Adults

Completed·JJohann Wolfgang Goethe University Hospital·Phase 4·NCT00199017·75 enrolled

International Cooperative Treatment Protocol for Children and Adolescents With Lymphoblastic Lymphoma

Recruiting·UUniversity Hospital Muenster·Phase 3·NCT04043494·683 enrolled

Induction Chemotherapy3 trials

A Phase I/II Study of Induction Chemotherapy With Daunorubicin, Cytarabine, Topotecan and Etoposide

Completed·HH. Lee Moffitt Cancer Center and Research Institute·Phase 1/2·NCT00005793·41 enrolled

Venetoclax + Azacitidine vs. Induction Chemotherapy in AML

Recruiting·MMassachusetts General Hospital·Phase 2·NCT04801797·172 enrolled

Phase II Trial of Alisertib With Induction Chemotherapy in High-risk AML

Completed·MMassachusetts General Hospital·Phase 2·NCT02560025·42 enrolled

Chemotherapy3 trials

Entospletinib (ENTO) as Monotherapy and in Combination With Chemotherapy in Japanese Adults

Terminated· Gilead logo

Gilead·Phase 1·NCT03135028·9 enrolled

Venetoclax Plus Intensive Chemotherapy in AML and Advanced MDS

Recruiting·MMontefiore Medical Center·Phase 1·NCT05342584·99 enrolled

Randomized Phase III Study of Intensive Chemotherapy With or Without Dasatinib (Sprycel™)

Completed·UUniversity of Ulm·Phase 3·NCT02013648·204 enrolled

Acute Myeloid Leukemia (AML)3 trials

Phase 3 Randomized, Double-blind, Placebo-controlled Studies Assessing Ziftomenib in Combination With Either Standard of Care Nonintensive (Venetoclax+Azacitidine) or Intensive (7+3) Therapy in Patients With Untreated NPM1 Mutated or KMT2A Rearranged Acute Myeloid Leukemia

Recruiting·KKura Oncology, Inc.·Phase 3·NCT07007312·1,300 enrolled

VISTA-AML- Venetoclax Intensity Selection Trial in AML: A Randomized Phase II Selection Trial of Venetoclax-Based Induction Intensity in Newly Diagnosed Acute Myeloid Leukemia

Not yet recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·Phase 2·NCT07754799·320 enrolled

Phase II/III Randomized Study to Improve Overall Survival in 18 to 60 Year-old Patients, Comparing Daunorubicin Versus High Dose Idarubicin Induction Regimens, High Dose Versus Intermediate Dose Cytarabine Consolidation Regimens, and Standard Versus Mycophenolate Mofetil Prophylaxis of Graft Versus Host Disease in Allografted Patients in First CR : a Backbone InterGroup-1 Trial

Recruiting·UUniversity Hospital, Angers·Preclinical·NCT02416388·3,100 enrolled

Acute Leukemia of Ambiguous Lineage2 trials

Efficacy of Acute Lymphoblastic Leukemia-Based Therapy in Treating Patients With Acute Leukemia of Ambiguous Lineage

Recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·Phase 2·NCT04440267·50 enrolled

A Phase 2 Study of Blinatumomab in Combination With Chemotherapy for Infants With Newly Diagnosed Acute Lymphoblastic Leukemia With Randomization of KMT2A-Rearranged Patients to Addition of Venetoclax

Recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT06317662·153 enrolled

Adult Acute Lymphoblastic Leukemia2 trials

Treatment of High Risk Adult Acute Lymphoblastic Leukemia

Completed·PPETHEMA Foundation·Phase 4·NCT00853008·100 enrolled

High-Dose Methotrexate (MTX) for Adult Acute Lymphoblastic Leukemia (ALL)

Unknown status·JJapan Adult Leukemia Study Group·Phase 3·NCT00131027·240 enrolled

T-cell acute lymphoblastic leukemia2 trials

Adding Targeted Drugs to Usual Chemotherapy for Adults With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia (T-ALL) and T-Cell Lymphoblastic Lymphoma (T-LBL)

Withdrawn·NNational Cancer Institute (NCI)·Phase 2·NCT06210750

SJALL23T: Adding Dasatinib Or Venetoclax To Improve Responses In Children With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia (ALL) Or Lymphoma (T-LLY) Or Mixed Phenotype Acute Leukemia (MPAL)

Recruiting·SSt. Jude Children's Research Hospital·Phase 2·NCT06390319·100 enrolled

Acute Leukemia2 trials

Low Dose Daunorubicin in Pediatric Relapsed/Refractory Acute Leukemia

Completed·—·Phase 2·NCT04562792·1 enrolled

Low-Dose Daunorubicin in Relapsed/Refractory Acute Leukemia

Completed·TTara Lin·Phase 1·NCT02914977·18 enrolled

Childhood Acute Lymphoblastic Leukemia2 trials

Childhood Acute Lymphoblastic Leukemia Treatment Protocol Moscow-Berlin 2015 (ALL-MB 2015)

Unknown status·FFederal Research Institute of Pediatric Hematology, Oncology and Immunology·N/A·NCT03390387·4,000 enrolled

Childhood Acute Lymphoblastic Leukemia Treatment Protocol Moscow-Berlin 2008

Unknown status·FFederal Research Institute of Pediatric Hematology, Oncology and Immunology·N/A·NCT01953770·3,000 enrolled

Safety and Efficacy1 trial

A Safety and Efficacy Study of Eltrombopag in Subjects With AML

Completed· Novartis logo

Novartis·Phase 2·NCT01890746·148 enrolled

Treatment1 trial

LAL-BR/2001: Study Treatment to Low Risk ALL

Completed·PPETHEMA Foundation·Phase 4·NCT00526175·150 enrolled

Untreated AML1 trial

A Study of Selinexor in Combination With Daunorubicin and Cytarabine for Untreated AML

Completed·HH. Lee Moffitt Cancer Center and Research Institute·Phase 1·NCT02403310·21 enrolled

Relapsed/Refractory B-cell ALL1 trial

Phase I Study of Inotuzumab With Augmented BFM Re-Induction for Patients With Relapsed/Refractory B-cell ALL

Active, not recruiting·UUniversity of Virginia·Phase 1·NCT03962465·36 enrolled

ART1 trial

A Study to Investigate the Safety and Tolerability of Ziftomenib in Combination With Venetoclax/Azacitidine, Venetoclax, 7+3, or 7+3+Quizartinib in Patients With AML

Recruiting·KKura Oncology, Inc.·Phase 1·NCT05735184·420 enrolled

CAR1 trial

A Safety Study of SGN-CD33A in Combination With Standard-of-care in Patients With AML

Completed· Pfizer logo

Pfizer·Phase 1·NCT02326584·116 enrolled

Hematologic Malignancies1 trial

A Study Of PF-04449913 In Japanese Patients With Select Hematologic Malignancies

Completed· Pfizer logo

Pfizer·Phase 1·NCT02038777·48 enrolled

Adult1 trial

MLN 9708 in Induction and Consolidation for Adults With AML >= 60 Years of Age

Completed·MMassachusetts General Hospital·Phase 1·NCT02582359·39 enrolled

Pilot Study1 trial

Pilot Study Efficacy and Tolerance Fish Oil Emulsion Daunorubicin and Cytarabine Treatment of AML Younger Patients

Completed·FFrench Innovative Leukemia Organisation·Phase 2·NCT01999413·30 enrolled

Elderly Patients1 trial

HAV Versus DAV/IAV Induction Regimen in Elderly Patients With AML

Recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·Phase 2·NCT06744556·60 enrolled

Induction Therapy1 trial

Optimum Induction Therapy of Low-risk APL

Recruiting·PPeking University People's Hospital·N/A·NCT05832320·74 enrolled

CLL1 trial

AflacLL1901 (CHOA-AML)

Terminated·EEmory University·Phase 2·NCT04326439·8 enrolled

Acute Promyelocytic Leukemia1 trial

AIDA2000 - Risk-Adapted Therapy for Patients With Acute Promyelocytic Leukemia

Unknown status·TTechnische Universität Dresden·Phase 4·NCT00180128·80 enrolled

Adult Acute Myeloid Leukemia1 trial

Treatment of Older Adult Acute Myeloid Leukemia Patients Aged 55 to 65 Years

Unknown status·JJianxiang Wang·N/A·NCT02432872·300 enrolled

Revumenib1 trial

Revumenib in Combination With 7+3 + Midostaurin in AML

Recruiting·RRichard Stone, MD·Phase 1·NCT06313437·22 enrolled

Kaposi's sarcoma1 trial

A Randomized Phase III Clinical Trial of Daunoxome Versus Combination Chemotherapy With Adriamycin/Bleomycin/Vincristine (ABV) in the Treatment of HIV-Associated Kaposi's Sarcoma.

Completed·NNexstar Pharmaceuticals·Phase 3·NCT00002093

Acute Lymphoid Leukemia1 trial

Adult Acute Lymphoblastic Leukemia Treated With Pediatric Regimen in Brazil - a Prospective Collaborative Study

Recruiting·IInstituto do Cancer do Estado de São Paulo··NCT05959720·180 enrolled

B Acute Lymphoblastic Leukemia1 trial

An International Phase 2 Study of Chemotherapy and Tyrosine Kinase Inhibitors With Blinatumomab in Patients With Newly-Diagnosed Philadelphia Chromosome-Positive or ABL-Class Philadelphia Chromosome-Like B-Cell Acute Lymphoblastic Leukemia

Recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT06124157·222 enrolled

Adult T Acute Lymphoblastic Leukemia1 trial

A Phase III Randomized Trial Investigating Bortezomib (NSC# 681239) on a Modified Augmented BFM (ABFM) Backbone in Newly Diagnosed T-Lymphoblastic Leukemia (T-ALL) and T-Lymphoblastic Lymphoma (T-LLy)

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 3·NCT02112916·847 enrolled

Pediatric Acute Leukemia1 trial

A Phase Ia/Ib Trial of Revumenib Combined With Cytarabine, Daunorubicin, and Gemtuzumab Ozogamicin (GO) in Frontline and Relapsed /Refractory Pediatric Acute Leukemia Patients

Withdrawn·MM.D. Anderson Cancer Center·Phase 1·NCT07052994

MDS1 trial

Primary Comparison of Liposomal Anthracycline Based Treatment Versus Conventional Care Strategies Before Allogeneic Stem Cell Transplantation in Patients With Higher Risk MDS and Oligoblastic AML

Completed·GGWT-TUD GmbH·Phase 2·NCT04061239·150 enrolled

Refractory Acute Myeloid Leukemia1 trial

A Master Protocol for Biomarker-Based Treatment of AML (The Beat AML Trial)

Recruiting·BBeat AML, LLC·Preclinical·NCT03013998·3,000 enrolled

AML, Adult1 trial

MRD-positive AML: a Prospective, Single-arm, Multicenter Platform Clinical Study

Recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·Preclinical·NCT07131059·537 enrolled

Leukemia, Acute Lymphoblastic1 trial

Phase 3 Trial to Investigate the Efficacy, Safety, and Tolerability of Blinatumomab as Consolidation Therapy Versus Conventional Consolidation Chemotherapy in Pediatric Subjects With HR First Relapse B-precursor ALL

Completed· Amgen logo

Amgen·Phase 3·NCT02393859·111 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 1, 1982

CERUBIDINE

NDA NDA050484

Apr 8, 1996

DAUNOXOME

NDA NDA050704

Jan 30, 1998

DAUNORUBICIN HYDROCHLORIDE

NDA NDA050731

Sources

References

[1]
ClinicalTrials.gov — 122 trial records for Daunorubicin. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Cerubidine drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Daunorubicin compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Daunorubicin. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA050731). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Hikma Pharmaceuticals LLC company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: DNA Topoisomerase II Alpha Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: HHikma Pharmaceuticals LLC

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