Ireland
--:--IST
Priya Life Science Compound trial record
Compound · clinical trials

Mitoxantrone clinical trials

Also listed in trial records as Mitoxantrone Hydrochloride, Dihydroxyanthracenedione, Mitozantrone, CL 232315, DHAD, DHAQ, Mitroxone, Neotalem, Novantrone, Onkotrone, Pralifan
Source: ClinicalTrials.gov, U.S. National Library of Medicine — the 13 trials in our Canada, Australia, Israel, China, Germany, Netherlands, Mexico, Ireland, France, Switzerland, Italy, Poland, Czechia, Turkey, Japan and South Korea registers that name Mitoxantrone as an intervention. Synced 9 Nov 2026
13Current trials
4Recruiting now
10Lead sponsors
16Country registers
At a glance

Mitoxantrone is named as an intervention in 13 current clinical trials in our Canada, Australia, Israel, China, Germany, Netherlands, Mexico, Ireland, France, Switzerland, Italy, Poland, Czechia, Turkey, Japan and South Korea registers. 4 are recruiting patients now. The most common phase is Phase 3. The sponsor with the most trials is Children's Oncology Group (3). The most-studied condition is Acute Myeloid Leukemia.

Where Mitoxantrone is approved

All regulators →

Of the three regulators tracked here, the first to approve Mitoxantrone was the US, on 23 Dec 1987.

USUnited States (FDA)
23 Dec 1987
Novantrone
NDA019297 on Drugs@FDA
First original NDA/BLA approval
EUEuropean Union (EMA)
No centralised EU authorisation (it may be authorised nationally)
First centralised authorisation
CACanada (Health Canada)
No new-drug Notice of Compliance since 1994
First new-drug NOC

From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.

How Mitoxantrone works

All drug targets →
  • DNA topoisomerase II alpha inhibitor Inhibitor
    Target: TOP2A DNA topoisomerase II alpha
    ✓ In ChEMBL and the Guide to Pharmacology
Diseases it has been tested for in clinical trials, by furthest phase
  • T-cell non-Hodgkin lymphomaPhase 3
  • Acute lymphoblastic leukemiaPhase 3
  • Acute myeloid leukemiaPhase 3
  • Acute myeloid leukemia by FAB classificationPhase 3
  • Breast cancerPhase 3
  • Chronic myeloid leukemiaPhase 3
  • Diffuse large B-cell lymphomaPhase 3
  • Follicular lymphomaPhase 3
  • Lymphoblastic lymphomaPhase 3
  • Lymphoplasmacytic lymphomaPhase 3
48 diseases in all

Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL58, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 7242, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.

Patient leaflets for Mitoxantrone

The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.

  • UK
    United Kingdom: Search MHRA Products
    Patient information leaflets and SmPCs for UK-licensed products.
  • US
    United States: Search DailyMed
    FDA-approved labels, including patient and medication guides.

Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.

Reference identifiers for Mitoxantrone

ATC code
L01DB07
ChEMBL
CHEMBL58
DrugBank
DB01204
PubChem CID
4212
CAS number
65271-80-9
FDA UNII
BZ114NVM5P
Wikidata
Q239426
Wikipedia
Mitoxantrone

Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.

Trials by status

  • Recruiting431%
  • Not yet open18%
  • Active, closed862%

Trials by phase

  • Phase 3538%
  • Phase 2215%
  • Phase 1215%
  • Phase 1/2215%
  • Not applicable18%
  • Phase 418%
01

Clinical trials of Mitoxantrone

13 trials
StudyPhaseStatusLead sponsorRegisters
A Study to Compare Standard Chemotherapy to Therapy With CPX-351 and/or Gilteritinib for Patients With Newly Diagnosed AML With or Without FLT3 Mutations
NCT04293562 · ClinicalTrials.gov ↗ · Acute Myeloid Leukemia
Phase 3 Recruiting Children's Oncology Group Canada, Mexico, Australia, Israel
CHIP-AML22/Quizartinib: Quizartinib + Chemotherapy in Newly Diagnosed Pediatric FLT3-ITD+ and NPM1wt AML Patients
NCT06262438 · ClinicalTrials.gov ↗ · Acute Myeloid Leukemia in Children
Phase 2 Recruiting Princess Maxima Center for Pediatric Oncology Netherlands
TINI 2: Total Therapy for Infants With Acute Lymphoblastic Leukemia II
NCT05848687 · ClinicalTrials.gov ↗ · Lymphoblastic Leukemia
Phase 1/2 Recruiting Tanja Andrea Gruber Canada
MRD-positive AML Clinical Study
NCT07131059 · ClinicalTrials.gov ↗ · AML, Adult
Not applicable Recruiting Institute of Hematology & Blood Diseases Hospital, China China
Application of Mitoxantrone Hydrochloride Injection in Transoral Robotic Thyroid Cancer Surgery
NCT07354698 · ClinicalTrials.gov ↗ · Papillary Thyroid Cancer
Phase 4 Not yet open Daping Hospital and the Research Institute of Surgery of the Third Military Medical University China
Blinatumomab in Treating Younger Patients With Relapsed B-cell Acute Lymphoblastic Leukemia
NCT02101853 · ClinicalTrials.gov ↗ · Recurrent B Acute Lymphoblastic Leukemia
Phase 3 Active, closed National Cancer Institute (NCI) Canada, Australia, Israel
Tretinoin and Arsenic Trioxide in Treating Patients With Untreated Acute Promyelocytic Leukemia
NCT02339740 · ClinicalTrials.gov ↗ · Acute Promyelocytic Leukemia With t(15;17)(q24.1;q21.2); PML-RARA
Phase 3 Active, closed Children's Oncology Group Canada, Australia, Israel
Response-Based Chemotherapy in Treating Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome in Younger Patients With Down Syndrome
NCT02521493 · ClinicalTrials.gov ↗ · Acute Myeloid Leukemia, Down Syndrome, Myelodysplastic Syndrome
Phase 3 Active, closed Children's Oncology Group Canada, Mexico, Australia
International Randomised Phase III Clinical Trial in Children With Acute Myeloid Leukaemia
NCT02724163 · Acute Myeloid Leukaemia
Phase 3 Active, closed University of Birmingham Ireland, France, Switzerland, Australia
A Global Study of Midostaurin in Combination With Chemotherapy to Evaluate Safety, Efficacy and Pharmacokinetics in Newly Diagnosed Pediatric Patients With FLT3 Mutated AML
NCT03591510 · ClinicalTrials.gov ↗ · FLT3-mutated Acute Myeloid Leukemia
Phase 2 Active, closed Novartis Pharmaceuticals Germany, Italy, Poland, Czechia, Turkey, Japan, South Korea
Total Therapy for Infants With Acute Lymphoblastic Leukemia (ALL) I
NCT02553460 · ClinicalTrials.gov ↗ · Acute Lymphoblastic Leukemia
Phase 1/2 Active, closed St. Jude Children's Research Hospital Canada
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
NCT02632708 · ClinicalTrials.gov ↗ · Newly Diagnosed Acute Myeloid Leukemia (AML), Untreated AML, AML Arising From Myelodysplastic Syndrome (MDS)
Phase 1 Active, closed Institut de Recherches Internationales Servier Germany, Netherlands
Testing the Addition of an Anti-cancer Drug, M3814, to the Usual Treatment (Mitoxantrone, Etoposide, and Cytarabine) for Relapsed or Refractory Acute Myeloid Leukemia
NCT03983824 · ClinicalTrials.gov ↗ · Recurrent Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
Phase 1 Active, closed National Cancer Institute (NCI) Israel

Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.

02

Conditions studied with Mitoxantrone

19 conditions
Acute Myeloid Leukemia2Acute Myeloid Leukaemia1AML, Adult1FLT3-mutated Acute Myeloid Leukemia1Newly Diagnosed Acute Myeloid Leukemia (AML)1Untreated AML1AML Arising From Myelodysplastic Syndrome (MDS)1AML Arising From Antecedent Hematologic Disorder (AHD)1Acute Myeloid Leukemia in Children1Recurrent B Acute Lymphoblastic Leukemia1Lymphoblastic Leukemia1Acute Lymphoblastic Leukemia1
All 19 conditions
Condition (as registered)Trials
Acute Myeloid Leukemia2
Acute Myeloid Leukaemia1
AML, Adult1
FLT3-mutated Acute Myeloid Leukemia1
Newly Diagnosed Acute Myeloid Leukemia (AML)1
Untreated AML1
AML Arising From Myelodysplastic Syndrome (MDS)1
AML Arising From Antecedent Hematologic Disorder (AHD)1
Acute Myeloid Leukemia in Children1
Recurrent B Acute Lymphoblastic Leukemia1
Lymphoblastic Leukemia1
Acute Lymphoblastic Leukemia1
Papillary Thyroid Cancer1
Acute Promyelocytic Leukemia With t(15;17)(q24.1;q21.2); PML-RARA1
Down Syndrome1
Myelodysplastic Syndrome1
Myeloid Leukemia Associated With Down Syndrome1
Recurrent Acute Myeloid Leukemia1
Refractory Acute Myeloid Leukemia1
05

Related compounds

06

Questions about Mitoxantrone trials

How many clinical trials are testing Mitoxantrone?

13 current trials in our Canada, Australia, Israel, China, Germany, Netherlands, Mexico, Ireland, France, Switzerland, Italy, Poland, Czechia, Turkey, Japan and South Korea registers name Mitoxantrone (also registered as CL 232315) as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.

Are Mitoxantrone trials recruiting patients?

Yes. 4 of the 13 trials are recruiting: 2 with sites in Canada, 1 with sites in Australia, 1 with sites in Israel, 1 with sites in China, 1 with sites in Netherlands and 1 with sites in Mexico. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.

Who sponsors Mitoxantrone clinical trials?

Children's Oncology Group (3), National Cancer Institute (NCI) (2), University of Birmingham (1) and Institute of Hematology & Blood Diseases Hospital, China (1), among 10 lead sponsors in total. The number in brackets is how many trials each organisation leads.

Are there Mitoxantrone clinical trials in Ireland?

Yes. 1 trial in our Ireland register (ClinicalTrials.gov). Some may be the same study registered in both. See the Irish clinical trials register for sites and contacts.

Where does this information come from?

Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Mitoxantrone works or whether it is effective, and it is not medical advice.

Approvals, shortages and trials, every Friday

One email a week with new EMA and FDA approvals, EU and US medicine shortages, how many trials are recruiting in Ireland, and the week's Irish pharma news.

Free. Unsubscribe from any email with one click. See our privacy policy.

How this page is built

Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Mitoxantrone works or whether it is effective. Each trial links to its own record so you can check it yourself.

This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Mitoxantrone (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 9 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician — our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us — we correct promptly and log it.