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Novantrone

(Mitoxantrone)

ApprovedSmall molecule

Mitoxantrone is used to treat certain types of cancer (including leukemia and lymphoma) and to reduce disability progression in multiple sclerosis by slowing down the disease.[2] Novantrone is currently approved and in use across 18 indications[4].[1]

Novantrone is one of 300 small molecule programs targeting Acute Myeloid Leukemia. It is currently in Approved.

18

Indications

100

Total Trials

14

Active Trials

299

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Acute Myeloid LeukemiaRecruiting

Newly DiagnosedCompleted

Lymphoid LeukemiaApproved

Central Nervous System CancerApproved

Non-Hodgkins LymphomaApproved

Secondary Progressive Multiple SclerosisApproved

Prostate AdenocarcinomaApproved

Hepatocellular CarcinomaApproved

Adult Acute Lymphoblastic LeukemiaActive, not recruiting

Acute Promyelocytic LeukemiaActive, not recruiting

Acute Myeloid LeukemiaPhase 3

Recruiting

Newly DiagnosedPhase 2

Completed

Lymphoid LeukemiaApproved

Approved

Central Nervous System CancerApproved

Approved

Non-Hodgkins LymphomaApproved

Approved

Secondary Progressive Multiple SclerosisApproved

Approved

Prostate AdenocarcinomaApproved

Approved

Hepatocellular CarcinomaApproved

Approved

Adult Acute Lymphoblastic LeukemiaApproved

Active, not recruiting

Acute Promyelocytic LeukemiaApproved

Active, not recruiting

Showing 10 of 18 indications

Competition

Competitive Landscape

265 competitors in Hepatocellular Carcinoma

#DrugCompanyPhaseTrials

Novantrone

Sovaldi

Viread

Ibrance

Cysteine Hydrochloride

Hepsera

Coreg

Akero Therapeutics

Vermox

Miraclid

TTechpool Bio-Pharma Co., Ltd.

Doptelet

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

Timeline

Expected Milestones

Q1 2027

Phase 1Recruiting

Recurrent Acute Myeloid Leukemia

NCT04375631

Phase 3Active, not recruiting

AML With FLT3 Mutation

NCT03182244

Q2 2027

Phase 2Active, not recruiting

Acute Myeloid Leukemia

NCT03164057

Q4 2027

Phase 1Recruiting

Acute Myeloid Leukemia

NCT06429449

Phase 1/2Recruiting

Acute Myeloid Leukemia

NCT04797767

Q4 2028

PreclinicalRecruiting

AML, Adult

NCT07131059

Clinical

Trials by Indication[1]

Acute Myeloid Leukemia18 trials

Lintuzumab-Ac225 in Combination with Cladribine + Cytarabine + Filgastrim + Mitoxantrone (CLAG-M) for Relapsed/Refractory Acute Myeloid Leukemia

Completed·MMedical College of Wisconsin·Phase 1·NCT03441048·26 enrolled

Mitoxantrone, Etoposide, and Cytarabine (MEC) Plus Lenalidomide for Relapsed or Refractory Acute Myeloid Leukemia

Completed·MMassachusetts General Hospital·Phase 2·NCT03118466·41 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

Show 15 more trials

Continuous Infusion Chemotherapy (CI-CLAM) for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia or Other High-Grade Myeloid Neoplasms

Terminated·UUniversity of Washington·Phase 1·NCT04196010·13 enrolled

Biomarkers in Predicting Treatment Response to Sirolimus and Chemotherapy in Patients With High-Risk Acute Myeloid Leukemia

Completed·SSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University·Phase 2·NCT02583893·39 enrolled

Imatinib + MTC in Relapsed / Refractory Acute Myeloid Leukemia (AML)

Completed·GGoethe University·Phase 2·NCT00744081·130 enrolled

IV Plerixafor With Mitoxantrone Etoposide and Cytarabine for Acute Myeloid Leukemia (AML)

Terminated·WWashington University School of Medicine·Phase 1·NCT01027923·6 enrolled

Venetoclax-Navitoclax With Cladribine-based Salvage Therapy in Patients With Relapsed/Refractory Acute Myeloid Leukemia

Withdrawn·MMedical College of Wisconsin·Phase 1·NCT06007911

Chemosensitization With Plerixafor Plus G-CSF in Acute Myeloid Leukemia

Completed·WWashington University School of Medicine·Phase 1/2·NCT00906945·39 enrolled

AMD3100 Plus Mitoxantrone, Etoposide and Cytarabine in Acute Myeloid Leukemia

Completed·WWashington University School of Medicine·Phase 1/2·NCT00512252·52 enrolled

Phase I/II Study of Mitoxantrone, Etoposide and Gemtuzumab Ozogamicin for Acute Myeloid Leukemia

Terminated·UUniversity of Pittsburgh·Phase 1·NCT00660036·5 enrolled

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

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

A Study of DSP-2033 (Alvocidib) in Patients With Acute Myeloid Leukemia

Completed·SSumitomo Pharma Co., Ltd.·Phase 1·NCT03563560·10 enrolled

Mitoxantrone for Venetoclax Resistant Acute Myeloid Leukemia

Recruiting·UUniversity of Colorado, Denver·Phase 1·NCT06429449·30 enrolled

Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms

Recruiting·UUniversity of Washington·Phase 1/2·NCT04797767·62 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

Randomized Phase 2 Trial of CPX-351 (Vyxeos) vs. CLAG-M (Cladribine, Cytarabine, G-CSF, and Mitoxantrone) in Medically Less-Fit Adults With Acute Myeloid Leukemia (AML) or Other High-Grade Myeloid Neoplasm

Completed·FFred Hutchinson Cancer Center·Phase 2·NCT04195945·60 enrolled

Prostate Cancer13 trials

Phase II GM-CSF Plus Mitoxantrone in Hormone Refractory Prostate Cancer

Terminated·SStanford University·Phase 2·NCT00477087·10 enrolled

Trial of GM-CSF Given in Combination With Ketoconazole and Mitoxantrone in Patients With Progressive Prostate Cancer

Terminated·TThe Methodist Hospital Research Institute·Phase 2·NCT00447473·31 enrolled

Taxotere Prostate Cancer New Indication Registration Trial in China

Completed· Sanofi logo

Sanofi·Phase 3·NCT00436839·228 enrolled

Show 10 more trials

A Study of Olaratumab (IMC-3G3) in Prostate Cancer

Completed· Eli Lilly logo

Eli Lilly·Phase 2·NCT01204710·123 enrolled

Phase I Cabazitaxel, Mitoxantrone, and Prednisone Metastatic Castration-Resistant Prostate Cancer

Completed·RRahul Aggarwal·Phase 1·NCT01594918·25 enrolled

Mitoxantrone, Prednisone Plus Sorafenib in Taxane-Refractory Metastatic Hormone Refractory Prostate Cancer (HRPC)

Terminated·AAccelerated Community Oncology Research Network·Phase 2·NCT00452387·22 enrolled

Study of Cabozantinib (XL184) Versus Mitoxantrone Plus Prednisone in Men With Previously Treated Symptomatic Castration-resistant Prostate Cancer

Terminated·EExelixis·Phase 3·NCT01522443·119 enrolled

S9916, Combination Therapy in Treating Patients With Advanced Prostate Cancer That Has Not Responded to Hormone Therapy

Completed·SSWOG Cancer Research Network·Phase 3·NCT00004001·770 enrolled

AMG 102 in Combination With Mitoxantrone and Prednisone in Subjects With Previously Treated Castrate Resistant Prostate Cancer

Completed· Amgen logo

Amgen·Phase 1/2·NCT00770848·162 enrolled

Mitoxantrone ± Cetuximab 2nd Line Androgen Independent Prostate Cancer (AIPC)

Completed·UUS Oncology Research·Phase 2·NCT00661492·115 enrolled

A Safety and Efficacy Study of Siltuximab (CNTO 328) in Male Subjects With Metastatic Hormone-Refractory Prostate Cancer (HRPC)

Terminated·CCentocor, Inc.·Phase 2·NCT00385827·106 enrolled

A Study of IMC-A12 or Ramucirumab Plus Mitoxantrone and Prednisone in Prostate Cancer

Completed· Eli Lilly logo

Eli Lilly·Phase 2·NCT00683475·138 enrolled

Study of Irofulven in Patients With Hormone-refractory Prostate Cancer

Completed· Eisai logo

Eisai·Phase 2·NCT00124566·135 enrolled

Acute Lymphoblastic Leukemia8 trials

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

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

German Multicenter Trial for Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Adults (05/93)

Completed·GGoethe University·Phase 4·NCT00199069·720 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 5 more trials

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

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

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

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

TINI 2: Total Therapy for Infants With Acute Lymphoblastic Leukemia II

Recruiting·TTanja Andrea Gruber·Phase 1/2·NCT05848687·90 enrolled

Total Therapy for Infants With Acute Lymphoblastic Leukemia (ALL) I

Active, not recruiting·SSt. Jude Children's Research Hospital·Preclinical·NCT02553460·50 enrolled

Chemotherapy5 trials

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

Lenalidomide Plus Chemotherapy for AML

Completed·MMassachusetts General Hospital·Phase 1·NCT01681537·36 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 2 more trials

A Pilot Study of Decitabine and Vorinostat With Chemotherapy for Relapsed ALL

Terminated·TTherapeutic Advances in Childhood Leukemia Consortium·Phase 1/2·NCT01483690·23 enrolled

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

Lymphoma4 trials

Combination Chemotherapy and Rituximab With Pegfilgrastim Followed by Rituximab, in Large B-Cell Non-Hodgkin's Lymphoma

Completed·SSCRI Development Innovations, LLC·Phase 2·NCT00193479·51 enrolled

Efficacy , Safety of Treatment R NIMP for Relapsed Aggressive Lymphomas

Completed·FFrench Innovative Leukemia Organisation·Phase 2·NCT00842595·50 enrolled

Fludarabine, Mitoxantrone and Rituximab in Relapsed or Primary Failing Advanced Follicular Non-Hodgkin's Lymphoma

Completed·LLymphoma Study Association·Phase 2·NCT00169208·50 enrolled

Show 1 more trial

Study Comparing Inotuzumab Ozogamicin In Combination With Rituximab Versus Defined Investigator's Choice In Follicular Non-Hodgkin's Lymphoma (NHL)

Terminated· Pfizer logo

Pfizer·Phase 3·NCT00562965·29 enrolled

38 more indications

Follicular Lymphoma3 trials

Bortezomib (Velcade) With Standard Chemotherapy for Relapsed or Refractory Follicular Lymphoma

Terminated·—·Phase 2·NCT00510887·14 enrolled

Rituximab, Fludarabine, Mitoxantrone, Dexamethasone (R-FND) Plus Zevalin for High-Risk Follicular Lymphoma

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT00290511·49 enrolled

Bendamustine, Mitoxantrone, and Rituximab (BMR) for Patients With Untreated High Risk Follicular Lymphoma

Terminated·MM.D. Anderson Cancer Center·Phase 2·NCT00901927·14 enrolled

Acute Promyelocytic Leukemia3 trials

Treatment of Newly Diagnosed Patients With Acute Promyelocytic Leukemia (PETHEMA LPA 2005)

Completed·PPETHEMA Foundation·Phase 4·NCT00408278·300 enrolled

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

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

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

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

Acute Leukemia2 trials

Clofarabine, Etoposide, and Mitoxantrone for Relapsed and Refractory Acute Leukemias

Terminated·MMilton S. Hershey Medical Center·Phase 1·NCT00882076·22 enrolled

Mitoxantrone and Clofarabine for Treatment of Recurrent NHL or Acute Leukemia

Completed·NNew York Medical College·Phase 1/2·NCT01842672·41 enrolled

Neuromyelitis Optica2 trials

A Pilot Study of Mitoxantrone for the Treatment of Recurrent Neuromyelitis Optica (Devic's Disease)

Completed·SState University of New York at Buffalo·Phase 4·NCT00304291·5 enrolled

Efficacy and Safety of Mitoxantrone in Patients With Refractory Neuromyelitis Optica and Spectrum Disorders

Unknown status·XXuanwu Hospital, Beijing·Phase 4·NCT02021825·50 enrolled

Newly Diagnosed2 trials

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

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

Chronic Lymphocytic Leukemia2 trials

FCM-R (Fludarabine, Cyclophosphamide, Mitoxantrone, Rituximab) in Previously Untreated Patients With Chronic Lymphocytic Leukemia (CLL) < 70 Years

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT00254410·30 enrolled

Combination Chemotherapy With or Without G-CSF in Treating Patients With Relapsed Chronic Lymphocytic Leukemia

Terminated·GGerman CLL Study Group·Phase 3·NCT00416910·83 enrolled

Mantle Cell Lymphoma2 trials

A Study of MabThera (Rituximab) Addition to Regularly Prescribed Chemotherapy in Patients With Untreated Mantle Cell Lymphoma.

Terminated· Roche logo

Roche·Phase 2·NCT01144403·8 enrolled

Chemotherapy Followed by Zevalin for Relapsed Mantle Cell Lymphoma

Completed·—·Phase 2·NCT00119730·30 enrolled

Multiple Sclerosis2 trials

National Multicenter, Controlled, Single-blind Study With Two Parallel Groups Evaluating the Safety and Efficacy of Sequential Treatment With Mitoxantrone and Interferon Versus Interferon Alone in Patients With Strong Risk of Progression in the Initial Phase of Multiple Sclerosis

Completed·RRennes University Hospital·Phase 3·NCT02937285·35 enrolled

Study Evaluating Mitoxantrone in Multiple Sclerosis

Terminated· Pfizer logo

Pfizer·Phase 3·NCT00146159·336 enrolled

Diffuse Large B-Cell Lymphoma2 trials

Dose Dense Chemotherapy + Rituximab +/-Intensified High Dose Chemoimmunotherapy With Support of Peripheral Autologous Stem Cell in Diffuse Large B-Cell Lymphoma

Unknown status·FFondazione Italiana Linfomi - ETS·Phase 3·NCT00499018·399 enrolled

Rituximab in Addition to Chemotherapy With Autologous Stem Cell Transplantation as Treatment Diffuse Large B-Cell Lymphoma

Completed·GGruppo Italiano Multiregionale per lo studio dei Linfomi e delle Leucemie·Phase 2·NCT00556127·94 enrolled

Myelodysplastic Syndrome2 trials

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

Filgrastim, Cladribine, Cytarabine, and Mitoxantrone With Sorafenib in Treating Patients With Newly-Diagnosed, Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome

Completed·UUniversity of Washington·Phase 1/2·NCT02728050·84 enrolled

Leukemia2 trials

Phase I Study of Mitoxantrone and Etoposide Combined With Hydroxychloroquine, for Relapsed Acute Myelogenous Leukemia

Terminated·—·Phase 1·NCT02631252·1 enrolled

Pilot Trial of Sirolimus/MEC in High Risk Acute Myelogenous Leukemia (AML)

Completed·SSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University·N/A·NCT01184898·36 enrolled

Biomarker1 trial

Alvocidib Biomarker-driven Phase 2 AML Study

Terminated· Sumitomo Pharma America, Inc. logo

Sumitomo Pharma America, Inc.·Phase 2·NCT02520011·104 enrolled

Refractory AML1 trial

Gemtuzumab Ozogamicin in Combination With A-HAM in Refractory AML (GO-A-HAM)

Completed·UUniversity of Ulm·Phase 2·NCT00143975·95 enrolled

Trial1 trial

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

T-cell acute lymphoblastic leukemia1 trial

Re-Induction Therapy for Relapsed Pediatric T-Cell Acute Lymphoblastic Leukemia or Lymphoma

Terminated·SSt. Jude Children's Research Hospital·Phase 2·NCT02518750·3 enrolled

Relapsed/Refractory1 trial

GM-CLAG in Relapsed/Refractory FLT3-mutated AML

Withdrawn·AAyman H Qasrawi·Phase 1·NCT05330377

Myeloid Leukemia1 trial

A Study for Improving the Outcome of Childhood Acute Promyeloid Leukemia

Completed·SSouth China Children's Leukemia Group·Phase 4·NCT02200978·176 enrolled

Relapsing-Remitting Multiple Sclerosis1 trial

Evaluation of a New Therapeutic Strategy in Early and Active Relapsing-Remitting Multiple Sclerosis

Terminated·RRennes University Hospital·Phase 2·NCT00219908·124 enrolled

Relapsed/Refractory AML1 trial

Prexasertib in Combination With MEC in Relapsed/Refractory AML and High Risk MDS - a Phase I Trial

Terminated·—·Phase 1·NCT03735446·2 enrolled

Induction Chemotherapy1 trial

Brentuximab Vedotin + Re-induction Chemotherapy for AML

Completed·MMassachusetts General Hospital·Phase 1·NCT01830777·22 enrolled

Precursor B-Cell Acute Lymphoblastic Leukemia1 trial

Therapy for Pediatric Relapsed or Refractory Precursor B-Cell Acute Lymphoblastic Leukemia and Lymphoma

Completed·SSt. Jude Children's Research Hospital·Phase 2·NCT01700946·80 enrolled

Adult Acute Lymphoblastic Leukemia1 trial

Treatment of High Risk Adult Acute Lymphoblastic Leukemia

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

Treatment1 trial

Optimal Treatment Strategy Based on for Pediatric AML

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

Transplantation1 trial

High-dose Cytarabine/Mitoxantrone Followed by Autotransplantation for t-MDS/t-AML

Completed·UUniversity of Chicago·Phase 2·NCT00774046·32 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

Hematologic Malignancies1 trial

Bortezomib and Vorinostat in Younger Patients With Refractory or Relapsed MLL Rearranged Hematologic Malignancies

Terminated·SSt. Jude Children's Research Hospital·Phase 2·NCT02419755·12 enrolled

Metastatic Prostate Cancer1 trial

XRP6258 Plus Prednisone Compared to Mitoxantrone Plus Prednisone in Hormone Refractory Metastatic Prostate Cancer

Completed· Sanofi logo

Sanofi·Phase 3·NCT00417079·755 enrolled

Myeloid Malignancies1 trial

Study of Magrolimab Combinations in Participants With Myeloid Malignancies

Terminated· Gilead logo

Gilead·Phase 2·NCT04778410·54 enrolled

Relapsed or Refractory1 trial

Four Drug Reinduction With Bortezomib for Relapsed or Refractory ALL or LL in Children and Young Adults

Terminated·—·Phase 2·NCT02535806·2 enrolled

Intravenous1 trial

Phase I Study of Weekly Intravenous PS-341 (Bortezomib) Plus Mitoxantrone

Completed·MM.D. Anderson Cancer Center·Phase 1·NCT00059631·42 enrolled

Lip1 trial

Phase I and Pharmacokinetic Study of Mitoxantrone Hydrochloride Liposome Injection

Completed· CSPC ZhongQi Pharmaceutical Technology Co., Ltd. logo

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.·Phase 1·NCT02043756·20 enrolled

Recurrent Acute Myeloid Leukemia1 trial

CLAG-M or FLAG-Ida Chemotherapy Followed Immediately by Related/Unrelated Reduced-Intensity Conditioning (RIC) Allogeneic Hematopoietic Cell Transplantation for Adults With Myeloid Malignancies at High Risk of Relapse: A Phase 1 Study

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

Recurrent B Acute Lymphoblastic Leukemia1 trial

Risk-Stratified Randomized Phase III Testing of Blinatumomab (NSC#765986) in First Relapse of Childhood B-Lymphoblastic Leukemia (B-ALL)

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 3·NCT02101853·669 enrolled

AML With FLT3 Mutation1 trial

Phase 3 Open-label, Multicenter, Randomized Study of ASP2215 Versus Salvage Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FLT3 Mutation

Active, not recruiting· Astellas logo

Astellas·Phase 3·NCT03182244·276 enrolled

FLT3-mutated Acute Myeloid Leukemia1 trial

A Phase II, Open-label, Single Arm Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Twice Daily Midostaurin (PKC412) Combined With Standard Chemotherapy and as a Single Agent Post-consolidation Therapy in Children With Untreated FLT3-mutated AML

Active, not recruiting· Novartis logo

Novartis·Phase 2·NCT03591510·22 enrolled

Acute Myeloid Leukaemia1 trial

International Randomised Phase III Clinical Trial in Children With Acute Myeloid Leukaemia - Incorporating an Embedded Dose Finding Study for Gemtuzumab Ozogamicin in Combination With Induction Chemotherapy

Active, not recruiting·UUniversity of Birmingham·Phase 3·NCT02724163·700 enrolled

Unspecified2 trials

Ph2 Gem/Nov/Rituxan Rel/Ref MantleCell

Completed·UUS Oncology Research·Phase 2·NCT00656084·16 enrolled

Medium Dose of Cytarabine and Mitoxantrone

Unknown status·SShenzhen People's Hospital··NCT04024241·250 enrolled

Regulatory

FDA Approval Timeline[5]

Dec 23, 1987

NOVANTRONE

NDA NDA019297

Sources

References

[1]
ClinicalTrials.gov — 100 trial records for Mitoxantrone. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Novantrone drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Mitoxantrone compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Mitoxantrone. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA019297). U.S. Food & Drug Administration.
[6]
SEC EDGAR — EMD Serono 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: EMD Serono

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