Idamycin

(idarubicin)

ApprovedSmall molecule

Idarubicin is used to treat certain types of leukemia (blood cancer). It works by damaging cancer cell DNA to stop them from growing and dividing.[2] Idamycin is currently approved and in use across 23 indications[4].[1]

Idamycin is one of 513 small molecule programs targeting Childhood Acute Lymphoblastic Leukemia. It is currently in Approved.

Indications

182

Total Trials

Active Trials

512

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Childhood Acute Lymphoblastic LeukemiaActive, not recruiting

Anaplastic Large Cell LymphomaActive, not recruiting

Central Nervous System LymphomaApproved

LymphomaActive, not recruiting

LeukemiaActive, not recruiting

Chronic Myelogenous LeukemiaActive, not recruiting

Liver CancerApproved

Acute Promyelocytic LeukemiaApproved

MyelofibrosisActive, not recruiting

Bone Marrow TransplantationActive, not recruiting

Childhood Acute Lymphoblastic LeukemiaPreclinical

Active, not recruiting

Anaplastic Large Cell LymphomaPreclinical

Active, not recruiting

Central Nervous System LymphomaApproved

Approved

LymphomaPhase 3

Active, not recruiting

LeukemiaPhase 3

Active, not recruiting

Chronic Myelogenous LeukemiaPhase 3

Active, not recruiting

Liver CancerApproved

Approved

Acute Promyelocytic LeukemiaApproved

Approved

MyelofibrosisPhase 2

Active, not recruiting

Bone Marrow TransplantationPhase 3

Active, not recruiting

Showing 10 of 23 indications

Competition

Competitive Landscape

1774 competitors in Lymphoma

#DrugCompanyPhaseTrials

Idamycin

Pfizer

Approved

6 2

Blenoxane

SSequus Pharmaceuticals

Preclinical

25 3

Velban

EEastern Cooperative Oncology Group

Preclinical

15 4

Oncaspar

SServier

Preclinical

15 5

Wellcovorin

GGlaxo Dba Glaxosmithkline

Preclinical

4 6

Tafasitamab

Incyte

Preclinical

7 7

Kenalog

BBausch Health Americas, Inc.

Preclinical

1 8

Nuvigil

NNuvo Research GmbH

Preclinical

1 9

PEG-Intron

Merck & Co.

Preclinical

1 10

Systemic Therapy

Bristol-Myers Squibb

Preclinical

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

Timeline

Expected Milestones

Q3 2026

Phase 1Active, not recruiting

Acute Myeloid Leukemia

NCT02632708

Q4 2026

Phase 1/2Active, not recruiting

Acute Myeloid Leukemia

NCT03330821

Q1 2027

Phase 1Recruiting

Chronic Myelomonocytic Leukemia

NCT04375631

Q2 2027

Phase 2Not yet recruiting

First-Line Treatment

NCT06050941

Phase 2Recruiting

Elderly Patients

NCT06744556

Phase 2Active, not recruiting

Acute Myeloid Leukemia

NCT03164057

Clinical

Trials by Indication[1]

Acute Myeloid Leukemia62 trials

Everolimus MICE-regimen in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia

Completed·GGruppo Italiano Malattie EMatologiche dell'Adulto·Phase 1·NCT01154439·11 enrolled

A Study of Indoximod in Combination With (7+3) Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia

Completed·NNewLink Genetics Corporation·Phase 1·NCT02835729·54 enrolled

Guadecitabine With or Without Idarubicin or Cladribine in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT02096055·44 enrolled

Show 59 more trials

Chemotherapy in Treating Children With Recurrent Acute Myeloid Leukemia

Completed·CChildren's Oncology Group·Phase 2·NCT00003178·120 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

Standard-dose vs Intermediate-dose Cytarabine Induction in the Treatment of Acute Myeloid Leukemia With RUNX1-RUNX1T1

Recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·Phase 3·NCT06744504·300 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

All-Trans Retinoic Acid in Combination With Standard Induction and Consolidation Therapy in Older Patients With Newly Diagnosed Acute Myeloid Leukemia

Completed·UUniversity of Ulm·Phase 3·NCT00151255·500 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

Dasatinib, Cytarabine, and Idarubicin in Treating Patients With High-Risk Acute Myeloid Leukemia

Terminated·—·Phase 1/2·NCT01876953·20 enrolled

High Dose Chemotherapy, Peripheral Stem Cell Transplantation, and Interleukin-2 in Treating Patients With Acute Myeloid Leukemia

Completed·RRoswell Park Cancer Institute·Phase 3·NCT00002945·61 enrolled

Allogeneic Hematopoietic Stem Cell Transplantation (AlloSCT) Initial Salvage Therapy for Induction Failure Acute Myeloid Leukemia (AML)

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT02441803·11 enrolled

Volasertib Combined With Induction Chemotherapy in Acute Myeloid Leukemia

Withdrawn·MMassachusetts General Hospital·Phase 1·NCT02905994

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

Combination Chemotherapy (FLAG-Ida) Followed Immediately by Reduced-Intensity Total Body Radiation Therapy and Donor Hematopoietic Cell Transplant for the Treatment of Adults Age 60 and Older With Newly Diagnosed Adverse-Risk Acute Myeloid Leukemia or Other High-Grade Myeloid Cancer

Recruiting·FFred Hutchinson Cancer Center·Phase 2·NCT07046078·20 enrolled

Idarubicin Overcomes MDR1 Induced Chemoresistance With Higher Induction Remission Rate and Quality Than Daunorubicin in Acute Myeloid Leukemia Patients

Unknown status·NNanfang Hospital, Southern Medical University··NCT01889407·94 enrolled

MEK Inhibitor MEK162, Idarubicin, and Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

Terminated·—·Phase 1·NCT02049801·1 enrolled

Pravastatin, Idarubicin, and Cytarabine in Treating Patients With Acute Myeloid Leukemia

Completed·FFred Hutchinson Cancer Center·Phase 1·NCT00107523

Bortezomib and Combination Chemotherapy in Treating Younger Patients With Recurrent, Refractory, or Secondary Acute Myeloid Leukemia

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00666588·52 enrolled

Combination Chemotherapy With or Without G-CSF in Treating Older Patients With Acute Myeloid Leukemia

Completed·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 3·NCT00002719·500 enrolled

Lestaurtinib, Cytarabine, and Idarubicin in Treating Younger Patients With Relapsed or Refractory Acute Myeloid Leukemia

Completed·CChildren's Oncology Group·Phase 1/2·NCT00469859·14 enrolled

Venetoclax With Combination Chemotherapy in Treating Patients With Newly Diagnosed or Relapsed or Refractory Acute Myeloid Leukemia

Recruiting·MM.D. Anderson Cancer Center·Phase 1/2·NCT03214562·116 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 Phase II Study of Selinexor Plus Cytarabine and Idarubicin in Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML)

Completed·GGSO Global Clinical Research BV·Phase 2·NCT02249091·42 enrolled

A Study of Volasertib Plus Induction Chemotherapy for Acute Myeloid Leukemia

Withdrawn·UUniversity of Alberta·Phase 1·NCT02527174

A Clinical Trial to Assess the Efficacy and Safety of the Combination of a Drug Call Quizartinib With Chemotherapy (FLAG-IDA) in Patients With Acute Myeloid Leukemia That Has Not Responded to the First Treatment or That Has Returned After the First Treatment

Unknown status·PPETHEMA Foundation·Phase 1/2·NCT04112589·63 enrolled

S0919 Idarubicin, Cytarabine, and Pravastatin in Treating Patients With Relapsed Acute Myeloid Leukemia

Completed·SSWOG Cancer Research Network·Phase 2·NCT00840177·115 enrolled

A Study of LY2181308 Sodium in Patients With Relapsed or Refractory Acute Myeloid Leukemia

Completed· Eli Lilly logo

Eli Lilly·Phase 2·NCT00620321·24 enrolled

Cytarabine and Daunorubicin Hydrochloride or Idarubicin and Cytarabine With or Without Vorinostat in Treating Younger Patients With Previously Untreated Acute Myeloid Leukemia

Completed·NNational Cancer Institute (NCI)·Phase 3·NCT01802333·754 enrolled

Trial to Compare Efficacy and Safety of Chemotherapy/Quizartinib vs Chemotherapy/Placebo in Adults FMS-like Tyrosine Kinase 3 (FLT3) Wild-type Acute Myeloid Leukemia (AML)

Completed·PPETHEMA Foundation·Phase 2·NCT04107727·273 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 1/2·NCT02310321·97 enrolled

Chemotherapy With or Without Gemtuzumab Ozogamicin in Treating Older Patients With Acute Myeloid Leukemia

Completed·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 3·NCT00052299·472 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

LY2510924, Idarubicin and Cytarabine in Patients With Relapsed or Refractory Acute Myeloid Leukemia

Completed·MM.D. Anderson Cancer Center·Phase 1·NCT02652871·36 enrolled

Alisertib for Acute Myeloid Leukemia

Completed·MMassachusetts General Hospital·Phase 1·NCT01779843·22 enrolled

HLA-mismatched Microtransplantation for High Risk Acute Myeloid Leukemia

Unknown status·TThe Affiliated Hospital of the Chinese Academy of Military Medical Sciences·Phase 3·NCT01484171·50 enrolled

Clofarabine, Cytarabine, and Idarubicin in Treating Patients With Intermediate-Risk or High-Risk Acute Myeloid Leukemia or High-Risk Myelodysplasia

Unknown status·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 1/2·NCT00838240·114 enrolled

Efficacy and Toxicity of Increasing Doses of Idarubicin, Cytarabine and G-CSF in Acute Myeloid Leukemia

Completed·GGrupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias·Phase 2·NCT01700413·48 enrolled

Amifostine and Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia

Completed·SSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University·Phase 1·NCT00003268

Ibrutinib, Idarubicin and Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

Terminated·SSteven E. Coutre·Phase 1·NCT02635074·2 enrolled

Study of Crenolanib Combined With Chemotherapy in FLT3-mutated Acute Myeloid Leukemia Patients

Completed·AArog Pharmaceuticals, Inc.·Phase 1/2·NCT02400281·28 enrolled

Risk-adapted Therapy for Primary Acute Myeloid Leukemia

Completed·GGrupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias·Phase 2·NCT04687098·1,034 enrolled

Pevonedistat, Cytarabine, and Idarubicin in Treating Patients With Acute Myeloid Leukemia

Active, not recruiting·UUniversity of Southern California·Phase 1/2·NCT03330821·53 enrolled

Dociparstat Sodium (CX-01) Combined With Standard Induction Therapy for Newly Diagnosed Acute Myeloid Leukemia

Completed· Jazz Pharmaceuticals logo

Jazz Pharmaceuticals·Phase 2·NCT02873338·75 enrolled

Standard Idarubicin and Cytarabine for the Treatment of Acute Myeloid Leukemia (AML)

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT00422591·175 enrolled

Dasatinib in Combination With Chemotherapy for Relapsed or Refractory Core Binding Factor Acute Myeloid Leukemia

Withdrawn·EEmory University·Phase 1·NCT02680951

Combination Chemotherapy in Treating Older Patients With Acute Myeloid Leukemia

Unknown status·RRiverside Haematology Group·Phase 3·NCT00003602·400 enrolled

Lenalidomide, Cytarabine, and Idarubicin in Treating Patients With Acute Myeloid Leukemia

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT01132586·61 enrolled

Gemtuzumab Ozogamicin With or Without Chemotherapy in Treating Older Patients With Acute Myeloid Leukemia

Completed·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 2·NCT00006122·106 enrolled

Safety and Efficacy Study of Idarubicin Dose Intensification to Treat Acute Myeloid Leukemia

Completed·KKonkuk University Medical Center·Phase 1/2·NCT01518556·49 enrolled

Safety and Tolerability of Ziftomenib Combinations in Patients With Relapsed/Refractory Acute Myeloid Leukemia

Recruiting·KKura Oncology, Inc.·Phase 1·NCT06001788·171 enrolled

Combination Chemotherapy (FLAG-Ida) With Pivekimab Sunirine (PVEK [IMGN632]) for the Treatment of Newly Diagnosed Adverse Risk Acute Myeloid Leukemia and Other High-Grade Myeloid Neoplasms

Recruiting·FFred Hutchinson Cancer Center·Phase 1·NCT06034470·30 enrolled

Idarubicin and Cytarabine With or Without Bevacizumab in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia

Terminated·NNational Cancer Institute (NCI)·Phase 2·NCT00096148·120 enrolled

Geriatric Assessment & Genetic Profiling to Personalize Therapy in Older Adults With Acute Myeloid Leukemia

Completed·UUniversity of Nebraska·Phase 2·NCT03226418·75 enrolled

Clofarabine, Idarubicin, and Cytarabine Combination in Acute Myeloid Leukemia (AML) Induction

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT01025154·63 enrolled

Idarubicin and High-Dose Cytarabine in Treating Patients With Acute Myeloid Leukemia

Completed·—·Phase 2·NCT00528398·111 enrolled

Arsenic Trioxide, Cytarabine, and Idarubicin in Treating Patients With Acute Myeloid Leukemia

Completed·RRoswell Park Cancer Institute·Phase 1·NCT00093483·61 enrolled

Risk-Adapted Therapy of Acute Myeloid Leukemia of Adults (18-60 Years) According to the Cytogenetic Result

Completed·UUniversity of Ulm·Phase 3·NCT00146120·400 enrolled

Sirolimus, Idarubicin, and Cytarabine in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia

Completed·SSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University·Phase 1·NCT01822015·55 enrolled

Study on All-Trans Retinoic Acid, Induction and Consolidation Therapy, and Pegfilgrastim After Consolidation Therapy in Younger Patients With Newly Diagnosed Acute Myeloid Leukemia

Completed·UUniversity of Ulm·Phase 2/3·NCT00151242·920 enrolled

Choline Magnesium Trisalicylate and Combination Chemotherapy in Treating Patients With Acute Myeloid Leukemia

Completed·RRutgers, The State University of New Jersey·Phase 2·NCT02144675·27 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

Acute Lymphoblastic Leukemia13 trials

German Multicenter Trial for Treatment of Elderly Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

Completed·GGoethe University·Phase 4·NCT00198978·377 enrolled

Chemotherapy With or Without Imatinib and/or Peripheral Stem Cell Transplant in Acute Lymphoblastic Leukemia

Completed·GGruppo Italiano Malattie EMatologiche dell'Adulto·Phase 2·NCT00458848·470 enrolled

Combination Chemotherapy in Treating Children With Relapsed Acute Lymphoblastic Leukemia

Completed·CChildren's Oncology Group·Phase 3·NCT00002816·120 enrolled

Show 10 more trials

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

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

Combination Chemotherapy in Treating Young Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia

Completed·CChildren's Cancer and Leukaemia Group·Phase 3·NCT00967057·470 enrolled

Personalized Kinase Inhibitor Therapy Combined With Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia

Completed·OOHSU Knight Cancer Institute·Phase 1·NCT02779283·7 enrolled

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

Study Comparing Imatinib With Chemotherapy as Induction in Elderly Patients With Philadelphia Positive Acute Lymphoblastic Leukemia (ALL)

Unknown status·JJohann Wolfgang Goethe University Hospital·Phase 2·NCT00199186

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

Treatment Protocol of Children With Philadelphia Chromosome Negative High Risk Acute Lymphoblastic Leukemia

Unknown status·CChinese Academy of Medical Sciences·Phase 4·NCT01990807·20 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

Treatment of Elderly Patients (>65 Years) With Acute Lymphoblastic Leukemia

Completed·GGoethe University·Phase 4·NCT00199095·40 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

Myelodysplastic Syndrome12 trials

Cladribine, Idarubicin, Cytarabine, and Quizartinib in Treating Patients With Newly Diagnosed, Relapsed, or Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome

Recruiting·MM.D. Anderson Cancer Center·Phase 1/2·NCT04047641·80 enrolled

Fludarabine Phosphate, Cytarabine, Filgrastim-sndz, Gemtuzumab Ozogamicin, and Idarubicin Hydrochloride in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT00801489·270 enrolled

Phase II Study of Idarubicin, Cytarabine, and Vorinostat With High-Risk Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML)

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT00656617·106 enrolled

Show 9 more trials

Combination Chemotherapy in Treating Children With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome

Completed·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 3·NCT00002517

Combination Chemotherapy With or Without Idarubicin and Peripheral Stem Cell Transplantation in Treating Patients With Leukemia or Myelodysplastic Syndrome

Unknown status·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 3·NCT00002989·207 enrolled

Idarubicin + Cytarabine and Lenalidomide in Patients With Myelodysplastic Syndrome (MDS), Acute Myeloid Leukemia (AML)

Completed·HH. Lee Moffitt Cancer Center and Research Institute·Phase 1/2·NCT00831766·51 enrolled

Intensive Compared With Nonintensive Chemotherapy in Treating Older Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome

Completed·LLeukemia Research Fund·Phase 3·NCT00005823·2,000 enrolled

Clofarabine, Idarubicin, and Cytarabine (CIA) Versus Fludarabine, Idarubicin, and Cytarabine (FLAI) in Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome

Completed·MM.D. Anderson Cancer Center·Phase 1/2·NCT01289457·282 enrolled

Idarubicin, Cytarabine, and Gemtuzumab Ozogamicin in Treating Patients With Previously Untreated High-Risk Myelodysplastic Syndrome or Acute Myeloid Leukemia Secondary to Myelodysplastic Syndrome

Completed·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 2·NCT00077116·31 enrolled

Combination Chemotherapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome or Acute Myelogenous Leukemia

Unknown status·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 3·NCT00002926·80 enrolled

Cladribine, Idarubicin, Cytarabine, and Venetoclax in Treating Patients With Acute Myeloid Leukemia, High-Risk Myelodysplastic Syndrome, or Blastic Phase Chronic Myeloid Leukemia

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT02115295·508 enrolled

Study of Idarubicin, Cytarabine, and Nivolumab in Patients With High-Risk Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML)

Completed·MM.D. Anderson Cancer Center·Phase 1/2·NCT02464657·44 enrolled

Leukemia10 trials

Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Lymphocytic Leukemia

Unknown status·HHannover Medical School·Phase 2·NCT00002532

VELCADE in Combination With Idarubicin and Cytosine Arabinoside in Patients With Acute Myelogenous Leukemia

Completed·MMassachusetts General Hospital·Phase 1·NCT00505700·36 enrolled

Treatment of Relapsed or Refractory Acute Myeloblastic Leukemia

Completed·PPETHEMA Foundation·Phase 1/2·NCT01435343·55 enrolled

Show 7 more trials

Combination Chemotherapy Plus Biological Therapy in Treating Patients With Acute Myelogenous Leukemia

Withdrawn·RRush University Medical Center·Phase 2·NCT00003405

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 Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Acute Myelogenous Leukemia

Unknown status·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 3·NCT00002549·1,520 enrolled

Combination Chemotherapy in Treating Children With Acute Lymphocytic Leukemia

Completed·CChildren's Oncology Group·Phase 3·NCT00002812·2,078 enrolled

Combination Chemotherapy in Treating Children With Very High Risk Acute Lymphocytic Leukemia

Completed·CChildren's Oncology Group·Phase 2·NCT00003783·36 enrolled

Combination Chemotherapy in Treating Patients With Relapsed Acute Myelogenous Leukemia

Unknown status·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 2·NCT00003758·60 enrolled

Combination Chemotherapy in Treating Children With Relapsed or Refractory Acute Lymphocytic Leukemia

Terminated·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 2·NCT00003729·13 enrolled

Acute Promyelocytic Leukemia9 trials

Chemotherapy Plus Monoclonal Antibody in Treating Patients With Acute Promyelocytic Leukemia

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT00016159·35 enrolled

Monoclonal Antibody Therapy and Chemotherapy in Treating Patients With Acute Promyelocytic Leukemia in Remission

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT00002609·40 enrolled

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

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

Show 6 more trials

Phase III Trial in Acute Promyelocytic Leukemia Patients

Completed·GGruppo Italiano Malattie EMatologiche dell'Adulto·Phase 3·NCT00482833·276 enrolled

Tretinoin and Arsenic Trioxide With or Without Idarubicin in Treating Patients With Acute Promyelocytic Leukemia

Terminated·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT00528450·1 enrolled

Tretinoin and Arsenic Trioxide in Treating Patients With Untreated Acute Promyelocytic Leukemia

Active, not recruiting·CChildren's Oncology Group·Phase 3·NCT02339740·158 enrolled

Combination Chemotherapy With or Without Bone Marrow Transplantation in Treating Patients With Acute Promyelocytic Leukemia

Unknown status·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 3·NCT00002701·750 enrolled

Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Promyelocytic Leukemia

Completed·CChildren's Oncology Group·Phase 3·NCT00866918·106 enrolled

Study for Patients With Newly Diagnosed, High-risk Acute Promyelocytic Leukemia

Completed·TTechnische Universität Dresden·Phase 3·NCT02688140·135 enrolled

42 more indications

Chronic Myelogenous Leukemia8 trials

Chemotherapy and Biological Therapy With or Without Bone Marrow or Peripheral Stem Cell Transplant in Treating Patients With Chronic Myelogenous Leukemia

Unknown status·IIII. Medizinische Klinik Mannheim·Phase 3·NCT00025402·1,000 enrolled

Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myelogenous Leukemia or Acute Leukemia

Completed·LLoyola University·Phase 2·NCT00004905

Bevacizumab, Idarubicin, and Cytarabine in Treating Patients With Blast Phase Chronic Myelogenous Leukemia

Terminated·NNational Cancer Institute (NCI)·Phase 2·NCT00023920·60 enrolled

Show 5 more trials

Chemotherapy in Treating Patients With Newly Diagnosed Acute or Chronic Myelogenous Leukemia or Myelodysplastic Syndrome

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT00002800·60 enrolled

Interferon-alfa With or Without Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Newly Diagnosed Chronic Myelogenous Leukemia

Completed·EEastern Cooperative Oncology Group·Phase 3·NCT00002868·744 enrolled

Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myelogenous Leukemia

Withdrawn·—·Phase 1/2·NCT00002761

Chemotherapy, Interferon, and Bone Marrow Transplantation in Treating Patients With Chronic Myelogenous Leukemia

Unknown status·GGerman CML Study Group·Phase 3·NCT00002771·750 enrolled

Peripheral Stem Cell Transplantation Plus Filgrastim in Treating Patients With Acute or Chronic Myelogenous Leukemia

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT00002833·53 enrolled

Lymphoma6 trials

A Safety and Efficacy Study of Ibrutinib in Pediatric and Young Adult Participants With Relapsed or Refractory Mature B-cell Non-Hodgkin Lymphoma

Terminated· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT02703272·72 enrolled

Salvage Therapy With Idarubicin in Relapsing CNS Lymphoma

Terminated·IInternational Extranodal Lymphoma Study Group (IELSG)·Phase 2·NCT00210366·25 enrolled

Combination Chemotherapy in Treating Patients With Lymphoma

Completed·MM.D. Anderson Cancer Center·Phase 3·NCT00002835·116 enrolled

Show 3 more trials

Combination Chemotherapy in Treating Patients With Intermediate-Grade or Immunoblastic Non-Hodgkin's Lymphoma

Completed·MM.D. Anderson Cancer Center·Phase 3·NCT00002565·61 enrolled

Combination Chemotherapy With or Without Interferon Alfa in Treating Patients With Low-Grade Non-Hodgkin's Lymphoma

Unknown status·SScotland and Newcastle Lymphoma Group·Phase 3·NCT00003639·200 enrolled

Phase I/II Study of Escalating Doses of Idarubicin Orally Given With Oral Cyclophosphamide, Etoposide, Prednisolone and Intravenous Rituximab in Elderly Patient With Disseminated High Grade Non Hodgkin Lymphoma

Completed·PPoitiers University Hospital·Phase 1/2·NCT01958996·27 enrolled

Myelodysplastic Syndromes5 trials

Idarubicin, Cytarabine, and Pravastatin Sodium in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndromes

Completed·FFred Hutchinson Cancer Center·N/A·NCT01831232·24 enrolled

Vorinostat and Idarubicin in Treating Patients With Relapsed or Refractory Leukemia or Myelodysplastic Syndromes

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT00331513·40 enrolled

Idarubicin, Cytarabine, and Tipifarnib in Treating Patients With Newly Diagnosed Myelodysplastic Syndromes or Acute Myeloid Leukemia

Completed·NNational Cancer Institute (NCI)·Phase 1/2·NCT00096122·95 enrolled

Show 2 more trials

E7070, Idarubicin and Cytarabine in Relapsed AML and High-Risk Myelodysplastic Syndromes

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT01692197·43 enrolled

SMD_FLAG-IDA_98: FLAG-IDA in Induction Treatment of High Risk Myelodysplastic Syndromes or Secondary Acute Myeloblastic Leukemia

Completed·PPETHEMA Foundation·Phase 4·NCT00487448·200 enrolled

Chemotherapy4 trials

Study to Determine Safety, Pharmacokinetics and Efficacy of GMI-1271 in Combination With Chemotherapy in AML

Completed·GGlycoMimetics Incorporated·Phase 1/2·NCT02306291·91 enrolled

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

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

Study Investigating the Efficacy of Crenolanib With Chemotherapy vs Chemotherapy Alone in R/R FLT3 Mutated AML

Unknown status·AArog Pharmaceuticals, Inc.·Phase 3·NCT03250338·322 enrolled

Show 1 more trial

Pilot Study of Crenolanib Combined With Standard Salvage Chemotherapy in Subjects With R/R AML

Completed·AArog Pharmaceuticals, Inc.·Phase 1/2·NCT02626338·16 enrolled

Multiple Myeloma3 trials

Thalidomide, Cyclophosphamide, Oral Idarubicin and Dexamethasone (T-CID) in Patients With Multiple Myeloma

Unknown status·UUniversity Hospital, Bonn·Phase 2·NCT00124813·80 enrolled

Chemotherapy Plus Steroid Therapy in Treating Patients With Multiple Myeloma

Unknown status·RRiverside Haematology Group·Phase 3·NCT00003603·660 enrolled

Combination Chemotherapy in Treating Patients With Stage II or Stage III Multiple Myeloma

Completed·WWest of Scotland Lymphoma Group·Phase 3·NCT00006232·200 enrolled

Induction Chemotherapy3 trials

Venetoclax + Azacitidine vs. Induction Chemotherapy in AML

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

Venetoclax + Decitabine vs. "7+3" Induction Chemotherapy in Young AML

Active, not recruiting·CChen Suning·Phase 3·NCT05177731·188 enrolled

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

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

Newly Diagnosed3 trials

Venetoclax, Azacitidine, and Mitoxantrone Hydrochloride Liposome Versus Idarubicin and Cytarabine in Newly Diagnosed AML

Not yet recruiting·TThe First Affiliated Hospital of Soochow University·Phase 3·NCT07486479·204 enrolled

Venetoclax-containing Therapy Combined With Microtransplant for Newly Diagnosed AML

Recruiting·—·Phase 2·NCT07078591·50 enrolled

Combination of Sorafenib With Standard Therapy in Newly Diagnosed Adult CBF AML

Unknown status·NNanfang Hospital, Southern Medical University·Phase 2·NCT05404516·88 enrolled

Elderly Patients2 trials

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

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

Bcl-2 Inhibitors Combined With Azacytidine and Chemotherapy in Elderly Patients With Previously Untreated AML

Unknown status·LLanZhou University·N/A·NCT05053425·30 enrolled

Relapsed AML2 trials

Phase I Using Velcade & Idarubicin in Elderly and Relapsed AML

Completed·UUniversity of Kentucky·Phase 1·NCT00382954·55 enrolled

Dosing Study of Ara-C/EL625/Idarubicin in Refractory and Relapsed AML

Completed·EEleos, Inc.·Phase 2·NCT00074737·53 enrolled

Chidamide2 trials

Precision Diagnosis Directing HDACi Chidamide Target Therapy for Adult T-LBL/ALL

Unknown status·NNanfang Hospital, Southern Medical University·Phase 2/3·NCT03564704·80 enrolled

Precision Diagnosis Directing HDACi Chidamide Target Therapy for Adult ETP-ALL

Unknown status·NNanfang Hospital, Southern Medical University·Phase 2/3·NCT03553238·70 enrolled

Hepatocellular Carcinoma2 trials

Chemoembolisation of Hepatocellular Carcinomas Not Subject to Interventive Care by Idarubicin-loaded Beads - IDASPHERE II

Completed·FFederation Francophone de Cancerologie Digestive·Phase 2·NCT02185768·46 enrolled

Chemoembolisation of Non Resectable, Non Metastatic Hepatocellular Carcinomas

Completed·—·Phase 1·NCT01040559·18 enrolled

Bone Marrow Transplantation2 trials

Combination Chemotherapy, Biological Therapy, and Bone Marrow Transplantation in Treating Patients With Acute Myeloid Leukemia

Unknown status·MMedical Research Council·Phase 3·NCT00002658·2,000 enrolled

Combination Chemotherapy With or Without Bone Marrow Transplantation in Treating Children With Acute Myelogenous Leukemia or Myelodysplastic Syndrome

Completed·NNational Cancer Institute (NCI)·Phase 3·NCT00002798·880 enrolled

Trial2 trials

Trial of DFP-10917 vs Non-Intensive or Intensive Reinduction for AML Patients in 2nd/3rd/4th Salvage

Terminated·DDelta-Fly Pharma, Inc.·Phase 3·NCT03926624·167 enrolled

Trial of PXD101 (Belinostat) in Combination With Idarubicin to Treat AML Not Suitable for Standard Intensive Therapy

Completed·VValerio Therapeutics·Phase 1/2·NCT00878722·41 enrolled

Treatment2 trials

Optimal Treatment Strategy Based on for Pediatric AML

Unknown status·SSamsung Medical Center·Phase 2·NCT02848183·350 enrolled

Clinical Guidelines for APL Treatment

Unknown status·PPETHEMA Foundation·Phase 4·NCT02020161·200 enrolled

Acute Leukemia2 trials

Clofarabine, Idarubicin, Cytarabine, Vincristine Sulfate, and Dexamethasone in Treating Patients With Newly Diagnosed or Relapsed Mixed Phenotype Acute Leukemia

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT02135874·16 enrolled

Decitabine Followed by Clofarabine, Idarubicin, and Cytarabine in Acute Leukemia

Completed·MM.D. Anderson Cancer Center·Phase 1/2·NCT01794702·65 enrolled

Acute Myeloblastic Leukaemia2 trials

Treatment of Adults Aged Up to 60 Years With De Novo Acute Myeloblastic Leukaemia,Secondary AML, or RAEB-T

Unknown status·HHannover Medical School·Phase 2/3·NCT00209833·200 enrolled

Treatment of the Acute Myeloblastic Leukaemia in Patients Over 65 Years

Completed·PPETHEMA Foundation·Phase 4·NCT00464217·100 enrolled

Acute Monocytic Leukemia1 trial

Treateament of Newly Diagnosed Acute Monocytic Leukemia in Children

Recruiting·SSun Yat-Sen Memorial Hospital of Sun Yat-Sen University·Phase 2/3·NCT05313958·43 enrolled

Maintenance Therapy1 trial

Trial Evaluating Induction Therapy With Idarubicin and Etoposide Plus Sequential or Concurrent Azacitidine and Maintenance Therapy With Azacitidine

Completed·UUniversity of Ulm·Phase 2·NCT01180322·277 enrolled

Efficacy1 trial

Efficacy of G-CSF-Priming in Elderly AML Patients

Unknown status·JJohann Wolfgang Goethe University Hospital·Phase 4·NCT00199147·250 enrolled

Acute Leukemia of Ambiguous Lineage1 trial

Study of Venetoclax in Combination With Chemotherapy in Pediatric Patients With Refractory or Relapsed Acute Myeloid Leukemia or Acute Leukemia of Ambiguous Lineage

Completed·SSt. Jude Children's Research Hospital·Phase 1·NCT03194932·62 enrolled

MACE1 trial

AML-02: Omacetaxine With Standard-of-Care Induction With Cytarabine & Idarubicin in Newly-Diagnosed AML Patients

Terminated·UUniversity of Illinois at Chicago·Phase 1/2·NCT02440568·22 enrolled

Terminated·FFred Hutchinson Cancer Center·Phase 2·NCT01607645·7 enrolled

Relapsed/Refractory AML1 trial

Efficacy of Idarubicin, Cytarabine and Cyclophosphamide (IAC) Regimen in Relapsed/Refractory AML

Completed·IInstitute of Hematology & Blood Diseases Hospital, China·Phase 2·NCT02937662·20 enrolled

First-line Treatment1 trial

Reduced Intensive Idarubicin and Cytarabine Plus Venetoclax as First-line Treatment for Adults AML and MDS

Not yet recruiting·FFirst Affiliated Hospital of Zhejiang University·Phase 2·NCT06050941·60 enrolled

Refractory AML1 trial

Selinexor (KPT-330) Plus FLAG-Ida for the Treatment of Relapsing/Refractory AML

Completed·PPETHEMA Foundation·Phase 1·NCT03661515·16 enrolled

Older Patients1 trial

Bendamustine and Idarubicin in Treating Older Patients With Previously Untreated AML or MDS

Completed·FFred Hutchinson Cancer Center·Phase 1/2·NCT01141725·39 enrolled

Myelofibrosis1 trial

Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Myelofibrosis

Completed·FFred Hutchinson Cancer Center·Phase 2·NCT00006367

Chronic Myelomonocytic Leukemia1 trial

CLAG-M or FLAG-Ida Chemotherapy and Reduced-Intensity Conditioning Donor Stem Cell Transplant for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Chronic Myelomonocytic Leukemia

Recruiting·FFred Hutchinson Cancer Center·Phase 1·NCT04375631·120 enrolled

OIC1 trial

All-trans Retinoic Acid, and Arsenic +/- Idarubicin

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT00413166·78 enrolled

AML1 trial

Epacadostat, Idarubicin and Cytarabine (EIC) in AML

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

Elderly1 trial

Comparing the Consolidation Regimens of IDA With Intermediate-dose Cytarabine Versus Intermediate-dose Cytarabine Alone for Elderly AML Patients

Unknown status·FFujian Medical University·Phase 2/3·NCT04216771·320 enrolled

Remission1 trial

Auto BMT for Non-M3 AML in 1st Remission in Pts </=60y of Age Using Busulfan/FTBI & VP16 as a Prep R

Completed·—·Phase 2·NCT00534469·60 enrolled

Conditioning1 trial

IDA+BUCY vs BUCY Conditioning Regimen for Intermediate-risk AML Undergoing Auto-HSCT

Completed·NNanfang Hospital, Southern Medical University·Phase 2/3·NCT02671708·153 enrolled

Myeloid Leukemia1 trial

Donor Lymphocytes to Prevent Graft-Versus-Host Disease in Patients With Chronic Myeloid Leukemia

Withdrawn·JJonsson Comprehensive Cancer Center·Phase 2·NCT00004878

Childhood Acute Lymphoblastic Leukemia1 trial

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

MDS1 trial

Adoptive Transfer of Haplo-identical DLI for AML and MDS

Completed·—·Phase 1/2·NCT02046122·19 enrolled

Stem Cell Transplant1 trial

Chemotherapy (Decitabine in Combination With FLAG-Ida) and Total-Body Irradiation Followed by Donor Stem Cell Transplant for the Treatment of Adults With Myeloid Malignancies at High Risk of Relapse

Recruiting·FFred Hutchinson Cancer Center·Phase 1/2·NCT06928662·36 enrolled

Prophylaxis1 trial

Study to Improve OS 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 MMF Prophylaxis of GvHD in Allografted Patients in First CR

Recruiting·UUniversity Hospital, Angers·Phase 2/3·NCT02416388·3,100 enrolled

Effects of Chemotherapy1 trial

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

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT03589729·100 enrolled

Sorafenib1 trial

Phase I-II Study of Idarubicin, Cytarabine, and Sorafenib (BAY43-9006)

Completed·MM.D. Anderson Cancer Center·Phase 1/2·NCT00542971·78 enrolled

Regulatory

FDA Approval Timeline[5]

Sep 27, 1990

IDAMYCIN

NDA NDA050661

Feb 17, 1997

IDAMYCIN PFS

NDA NDA050734

Sources

References

[1]
ClinicalTrials.gov — 182 trial records for idarubicin. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Idamycin drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — idarubicin compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for idarubicin. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA050734). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Pfizer 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: Pfizer

Idamycin

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q4 2026

Q1 2027

Q2 2027

Trials by Indication[1]

Acute Myeloid Leukemia62 trials

Acute Lymphoblastic Leukemia13 trials

Myelodysplastic Syndrome12 trials

Leukemia10 trials

Acute Promyelocytic Leukemia9 trials

Chronic Myelogenous Leukemia8 trials

Lymphoma6 trials

Myelodysplastic Syndromes5 trials

Chemotherapy4 trials

Multiple Myeloma3 trials

Induction Chemotherapy3 trials

Newly Diagnosed3 trials

Elderly Patients2 trials

Relapsed AML2 trials

Chidamide2 trials

Hepatocellular Carcinoma2 trials

Bone Marrow Transplantation2 trials

Trial2 trials

Treatment2 trials

Acute Leukemia2 trials

Acute Myeloblastic Leukaemia2 trials

Acute Monocytic Leukemia1 trial

Maintenance Therapy1 trial

Efficacy1 trial

Acute Leukemia of Ambiguous Lineage1 trial

MACE1 trial

MRD1 trial

Anaplastic Large Cell Lymphoma1 trial

Relapsed or Refractory1 trial

Relapsed/Refractory AML1 trial

First-line Treatment1 trial

Refractory AML1 trial

Older Patients1 trial

Myelofibrosis1 trial

Chronic Myelomonocytic Leukemia1 trial

OIC1 trial

AML1 trial

Elderly1 trial

Remission1 trial

Conditioning1 trial

Myeloid Leukemia1 trial

Childhood Acute Lymphoblastic Leukemia1 trial

MDS1 trial

Stem Cell Transplant1 trial

Prophylaxis1 trial

Effects of Chemotherapy1 trial

Sorafenib1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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