This page shows what was measured, who it was measured in, and what that does not settle.
What Mitoxantrone does in the body
Pain related to advanced hormone-refractory prostate cancer
From the FDA-approved label: Mitoxantrone, a DNA-reactive agent that intercalates into deoxyribonucleic acid (DNA) through hydrogen bonding, causes crosslinks and strand breaks. Mitoxantrone also interferes with ribonucleic acid (RNA) and is a potent inhibitor of topoisomerase II, an enzyme responsible for uncoiling and repairing damaged DNA. It has a cytocidal effect on both proliferating and nonproliferating cultured human cells, suggesting lack of cell cycle phase specificity. Mitoxantrone injection has been shown in vitro to inhibit B cell, T cell, and macrophage proliferation and impair antigen presentation, as well as the secretion of interferon gamma, TNFα, and IL-2.
What happened in people
RNAWiki has not yet published a reviewed conclusion for this use.
§ A fixed RNAWiki sentence
Where this came from
Wording RNAWiki always uses, not a finding about this substance.
No reviewed claim names a result for any goal on this record.
No source is stored against this line.
The limit that matters most
Not recorded.
Where it acts
Not recorded.
Kind of result
No result is published, so no kind of result applies yet
Supervision
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.
What the registries record it as
The substance registry classes this as chemical.
FDA substance registry · U6USW86RD0 · read 2026-08-29
Where each sentence above came from
No recorded sentence describes the change this makes in a way that stands on its own. The page opens with what it is taken for instead, and the recorded explanation follows below.
Shown as the opening line on this page.
No statement of the main limit is recorded.
The four opening statements run to 117 words.
Words this page uses
Four words worth knowing first
Chosen from what this page shows, with each one explained before the word it depends on.
Biomarker
A biomarker is a number from a test that stands in for something about health.
A picture of it, and where the picture fails
A biomarker is like a fuel gauge.
Where that stops being true. A gauge is wired to the tank. Many biomarkers are only loosely tied to health.
What people get wrong. A better number is read as a better life. Several medicines improved a number and helped nobody.
A measurable indicator used as a substitute for a clinical outcome of interest.
Placebo
A placebo is a dummy treatment given so the real one can be compared with it.
A picture of it, and where the picture fails
A placebo is like a blank control in an experiment.
Where that stops being true. A blank does nothing. People given a placebo often do get better.
What people get wrong. A placebo effect is read as imaginary. The improvement is measured and real.
An inactive intervention matched in appearance to the test intervention, used to control for non-specific effects.
Comparator
A comparator is whatever the treatment was measured against.
A picture of it, and where the picture fails
It is like the other runner in a race.
Where that stops being true. A race has one winner. A study can show both arms improved.
What people get wrong. Results are read without asking what the other group got. Beating nothing is not beating a treatment.
The control condition against which the experimental intervention is assessed.
What happened in people◇Read from sources, not yet reviewed
What happened in people
Each card is one study: the exact question it asked, who was in it, and whether it showed what it set out to show.
Adjuvant Chemotherapy Plus Radiation Therapy in Treating Women With Early-Stage Breast Cancer
✗ The study did not show it
Who was studied
NCT00003893
How many people
2250
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Injection
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
Combination Chemotherapy, Biological Therapy, and Bone Marrow Transplantation in Treating Patients With Acute Myeloid Leukemia
✗ The study did not show it
Who was studied
NCT00002658
How many people
2000
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Injection
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
Survival
✗ The study did not show it
Who was studied
NCT00005823
How many people
2000
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Injection
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
Combination Chemotherapy With or Without Bone Marrow Transplantation in Treating Children With Acute Myeloid Leukemia
✗ The study did not show it
Who was studied
NCT00003436
How many people
2000
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Injection
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
Event-free Survival (EFS) for Patients Without High Allelic Ratio FLT3/ITD+ Mutations
✗ The study did not show it
Who was studied
NCT01371981
How many people
1645
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Injection
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
Combination Chemotherapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Acute Myelogenous Leukemia
✗ The study did not show it
Who was studied
NCT00002549
How many people
1520
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Injection
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
What we know
RNAWiki holds 6 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.
What is missing or unclear◇Read from sources, not yet reviewed
Were people like you studied?
RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.
Who was studied
People similar to this profile were included.
Mitoxantrone injection, USP (concentrate) is indicated for reducing neurologic disability and/or the frequency of clinical relapses in patients with secondary (chronic) progressive, progressive relapsing, or worsening relapsing-remitting multiple sclerosis (i.e., patients whose neurologic status is significantly abnormal between relapses).
Who is missing from the studies
Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What the label states about particular groups
On people who are pregnant, the label states: “Mitoxantrone injection may cause fetal harm when administered to a pregnant woman.”
US prescribing information · 1634528a-30c5-4309-acc8-4c0293ae14ae · read 2026-08-30
Where the result stopped carrying
This is a scope explorer, not a diagnosis engine.
It shows who was studied so you can see whether people similar to you were included.
RNAWiki cannot tell whether a study fits you. It can show who was in it.
What it would be like to take◇Read from sources, not yet reviewed
Why it might seem to do nothing
A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.
It was studied in different people
The people in the studies were not much like the reader.
On this record: Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
The evidence may simply be wrong
Small early studies often do not hold up.
On this record: RNAWiki has not yet published a reviewed conclusion for this use.
Other reasons RNAWiki checked and found nothing for (11)
It was studied for a different goal
The studies measured something else entirely. Nothing in this record points to this reason.
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
There was nothing to correct
Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.
None of these is a reason to take more. Taking more is not a step this page ever suggests.
What it would be like to take◇Read from sources, not yet reviewed
What taking it involves
The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.
How it is supplied
Prescription only
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Read from the recorded approval status.
No source is stored against this line.
Form and route
Injection
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form and route recorded on this substance.
No source is stored against this line.
Who oversees it
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Suppression classes recorded: S1, S4, S6.
No source is stored against this line.
What is in the pack
Sold as injectable, injection, solution, concentrate, injection, solution, given by the injection, intravenous route.
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
Recorded notes on how this is sold and what that means for what is in the pack.
No source is stored against this line.
Where it is registered
Regulatory records are listed in the technical disclosure at the foot of this page.
# Counted from records
Where this came from
A count of rows RNAWiki holds. It describes our records, not your body.
Register entries are stored per jurisdiction and shown with their dates.
No source is stored against this line.
Why people stop
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
No record of why people stopped taking it is stored for this substance.
No source is stored against this line.
What it would be like to take∅Nothing found in the sources checked
What can go wrong
Sorted by where each line came from. A regulator's label and a report somebody sent in are not the same kind of fact.
∅Nothing found in the sources checked
No harm is recorded against this substance in the sources RNAWiki checked. Finding nothing is not the same as showing there is nothing.
The sources listed were searched and held nothing. That is not the same as nothing existing.
Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.
Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What is missing or unclear◇Read from sources, not yet reviewed
Does the exact form matter?
Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.
The form that was studied
Injection
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form used in the studies cited on this page.
No source is stored against this line.
What is sold
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
Nothing further is recorded about which forms are sold.
No source is stored against this line.
What is recorded as being sold
5 products list this as an active ingredient in the United States drug directory. 5 of them contain it and nothing else.
FDA National Drug Code directory · 71288-178 · read 2026-08-29
They are sold as injection, solution, injection, solution, concentrate and powder, taken intravenous.
FDA National Drug Code directory · 71288-178 · read 2026-08-29
The regulator's established pharmacologic class for it is topoisomerase inhibitor [epc] and topoisomerase inhibitors [moa].
FDA National Drug Code directory · 71288-178 · read 2026-08-29
3 published labels name it as an active ingredient. 3 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · 1634528a-30c5-4309-acc8-4c0293ae14ae · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · 1634528a-30c5-4309-acc8-4c0293ae14ae · read 2026-08-29
mitoXANTRONE is intravenous at HOW SUPPLIED Mitoxantrone injection, USP (concentrate) is a sterile aqueous solution containing mitoxantrone hydrochloride, USP at a concentration equivalent to 2 mg mitoxantrone free base per mL supplied in vials for m…, recorded as fda label in effect 2025-04-24 in the United States.
US prescribing information · 1634528a-30c5-4309-acc8-4c0293ae14ae · read 2026-08-30
Evidence carries across two names for one substance. It does not carry across a salt, a mirror form or a mixture.
What it would be like to take◇Read from sources, not yet reviewed
What you could measure
This one is decided with a clinician, so this section holds questions to ask rather than a plan to run.
Self-experiment planning is not offered for a prescription or clinician-supervised medicine. The questions below are for a clinician or pharmacist.
Questions worth asking
Which of the trials of Mitoxantrone studied people like me?
What was measured, and for how long?
Was the result a laboratory value or a health outcome?
What would we watch for, and when would we stop?
Tracking can show whether something changed for you. It cannot show what caused it.
RNAWiki records evidence. It does not say whether this substance is right for you.
What is missing or unclear◇Read from sources, not yet reviewed
What nobody knows yet
Open questions, each with why it is open and what would close it.
Missing populations
Which groups were under-represented in the studies has not been recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing long-term data
No completed tested study window is recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
No reviewed conclusion
RNAWiki has not yet published a reviewed conclusion for this use.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing interaction studies
No interaction was found in the registers checked. Not finding one is not the same as showing there is none.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Formulation uncertainty
Several salts, forms or products of Mitoxantrone are recorded. Results from one form may not transfer to another.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Mechanism not reviewed
No reviewed mechanism story exists for this substance.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
What happened in people◇Read from sources, not yet reviewed
Check any of this yourself
Every line above traced back to the study it came from. This is the technical layer, and the vocabulary changes here.
How many documents were read
3 documents were read for this substance.
RNAWiki source record
3 of them state the same volumeOfDistribution, and they agree.
RNAWiki source record
Where else this substance is registered
FDA substance identifier (UNII)
U6USW86RD0
RxNorm concept
197989
Checks this page had to pass
✓ Passed
Identity resolved
no open identity hold
✓ Passed
No unresolved merge across substance families
no quarantine open
✓ Passed
Every public sentence names a source
The opening statement carries the origin: Written into the record, not signed off.
✗ Not passed
Trial roles classified for highlighted evidence
No registered study is classified as testing this substance.
✓ Passed
No internal keys in reader text
enforced by the copy-contract test over the rendered page
✓ Passed
Safety mode resolved
Suppression classes recorded: S1, S4, S6.
✓ Passed
Canonical metadata present
slug and display name present
What is missing or unclear◇Read from sources, not yet reviewed
How this medicine reached us
Kept near the foot of the page. A historical event moves up only when it changes something about this substance today.
Withdrawn in United States, 2014, for "Failed Stability Specifications: Product is subpotent and has out of specification known and unknown impurities." (openFDA drug enforcement Class I recall)
What the approval register records
9 approved applications cover products containing this substance. The earliest was NDA019297, approved 19871223 to EMD SERONO.
This order is fixed in code and does not count clicks or time on the page.
What is not here
9 questions this page could not answer
These sections were prepared and left out because there was nothing to put in them. They are listed rather than hidden, so the gaps in this record are visible.
What was measured, goal by goal — found nothing in the sources checked.
How close this is to real life — found nothing in the sources checked.
The path through the body — found nothing in the sources checked.
Felt, measured, or meaningful — found nothing in the sources checked.
How long anything takes — found nothing in the sources checked.
What it may clash with — found nothing in the sources checked.
Other ways to the same goal — found nothing in the sources checked.
Claims that go past the evidence — found nothing in the sources checked.
What changed on this page — found nothing in the sources checked.
The record as stored
The full record, for auditing
Everything above is built from what is below. This layer keeps the technical vocabulary, record identifiers and every stored row, so a reader who wants to check the page can.
Recorded evidence blocks (10)
Q2
On the Mitoxantrone label: indicated for what?
"Mitoxantrone is indicated for reducing neurologic disability and/or the frequency of clinical relapses in patients with secondary (chronic) progressive, progressive relapsing, or worsening relapsing-remitting multiple sclerosis (i.e., patients whose neurologic status is significantly abnormal between relapses).…": indications and usage on Mitoxantrone's label. DailyMed label · accf9569-4b57-4e83-a7db-4e890a75d1ba · 2025-07-14
Q3
282 registered trials of Mitoxantrone — at which phases?
Registered studies posting no result
214 of 282
282 registered studies of Mitoxantrone: 152 phase2, 85 phase1, 59 phase3, 13 na, 9 phase4, 2 na or unstated. CLINICALTRIALS_SNAPSHOT · 2026-09-01
terminated; "Withdrawn because treatment guidelines changed"
NCT00005998
withdrawn; "Withdrawn because study never enrolled patients"
NCT00268242
terminated; "If \</= 5 of the initial 18 patients had a CR, the study would be stopped. Only 5 patients (21%) of 24 enrolled patients had a CR so the study was terminated."
14 further recorded trials
NCT00385827
terminated; "Prematurely stopped after Independent Data Monitoring Committee (IDMC) evaluation for lack of efficacy."
NCT00416910
terminated; "low recruitment"
NCT00447473
terminated; "PI decision"
NCT00452387
terminated; "Early stopping rule"
NCT00477087
terminated; "Low accrual"
NCT00510887
terminated; "Low accrual."
NCT00562965
terminated; "See termination reason in detailed description."
NCT00609739
terminated; "Low accrual"
NCT00660036
terminated; "due to new safety information"
NCT00882076
terminated; "study closed prematurely"
NCT00901927
terminated; "Study was closed early due to toxicity"
NCT01027923
terminated; "Withdrawal of support from sponsor"
NCT01260714
terminated; "Inadequate accrual rate"
NCT01483690
terminated; "Toxicity"
recorded 2026-09-01 · last checked 2026-09-04
Q5
Human studies of Mitoxantrone used (Novantrone®) Mitoxantrone 10mg/m² day1 — over how long?
studies of Mitoxantrone used the recorded amount. ClinicalTrials.gov · 2026-09-01
1 recorded entry; human; also "(Novantrone®) Mitoxantrone 10mg/m² day1"
Show the evidence
humanNCT00842595
(Novantrone®) Mitoxantrone 10mg/m² day1
recorded 2026-09-01 · last checked 2026-09-04
Q6
Mitoxantrone's half-life is 6 to 12 minutes — which schedules were studied?
6 to 12 minutes, the half-life Mitoxantrone's label states: "The mean alpha half-life of mitoxantrone is 6 to 12 minutes, the mean beta half-life is 1.1 to 3.1 hours and the mean gamma (terminal or elimination) half-life is 23 to 215 hours (median approximately 75 hours)." DailyMed label · accf9569-4b57-4e83-a7db-4e890a75d1ba · 2025-07-14
Show the evidence
half lifepharmacokinetics
6 to 12 minutes; The mean alpha half-life of mitoxantrone is 6 to 12 minutes, the mean beta half-life is 1.1 to 3.1 hours and the mean gamma (terminal or elimination) half-life is 23 to 215 hours (median approximately 75 hours).
metabolismpharmacokinetics
Metabolism and Elimination Mitoxantrone is excreted in urine and feces as either unchanged drug or as inactive metabolites.
recorded 2025-07-14 · last checked 2026-09-04
Q7
Which running trial of Mitoxantrone could settle lifespan?
NCT02101853 measures Disease Free Survival (DFS) of High-risk (HR) and Intermediate-risk (IR) Relapse Patients, reading out 2026-09-16.
10 open trials; n 669; "Blinatumomab in Treating Younger Patients With Relapsed B-cell Acute Lymphoblastic Leukemia"
Show the evidence
Trial
NCT02101853
"Blinatumomab in Treating Younger Patients With Relapsed B-cell Acute Lymphoblastic Leukemia"; n 669; "Disease Free Survival (DFS) of High-risk (HR) and Intermediate-risk (IR) Relapse Patients"; 2026-09-16
NCT03182244
"A Study of ASP2215 Versus Salvage Chemotherapy In Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase 3 (FLT3) Mutation"; n 276; "Overall Survival (OS)"; 2027-03-31
NCT02521493
"Response-Based Chemotherapy in Treating Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome in Younger Patients With Down Syndrome"; n 280; "Event-free Survival (EFS)"; 2027-06-30
NCT05717764
"Clinical Study of Mitoxantrone Hydrochloride Liposome Injection Combined With Capecitabine Versus Capecitabine Monotherapy in Patients With Recurrent Metastatic Nasopharyngeal Carcinoma Who Failed Platinum-containing Treatment"; n 500; "Progression-free survival (PFS) assessed by the independent review committee (IRC)"; 2027-09
NCT06621199
"Mitoxantrone Hydrochloride Liposome in Combination With Cytarabine and Venetoclax Regimen in Newly Diagnosed Elderly AML"; n 42; "2-year event-free survival (EFS) rate"; 2027-12-31
NCT07525466
"Combination of Mitoxantrone Liposome and Etoposide, Dexamethasone, Pegaspargase and Golidocitinib (MEPL-G) in the Treatment of NK/T-cell Lymphoma Associated Hemophagocytic Lymphohistiocytosis (NKTCL-HLH)"; n 25; "6-month overall survival (OS) rate"; 2028-09-30
4 further recorded trials
NCT07131059
"MRD-positive AML Clinical Study"; n 537; "relapse-free survival rate"; 2028-10-30
NCT02339740
"Tretinoin and Arsenic Trioxide in Treating Patients With Untreated Acute Promyelocytic Leukemia"; n 158; "Event-free Survival (EFS) in Standard Risk Acute Promyelocytic Leukemia (APL) Patients"; 2029-06-30
NCT04293562
"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"; n 1186; "Event-free survival (EFS)"; 2029-06-30
NCT02553460
"Total Therapy for Infants With Acute Lymphoblastic Leukemia (ALL) I"; n 50; "Percentage of Treatment-related Mortality (TRM)"; 2031-10
Q8
Which 83 trials of Mitoxantrone posted no result?
Posted no result
83 of 83 completed trials
Registrations
NCT00002674, NCT00003003, NCT00002576, NCT00003297, NCT00003080 and NCT00199069, and 77 more
Completion dates
oldest 2000-03; newest 2024-07-18
Show the evidence
Trial
NCT00002674
2000-03
NCT00003003
2000-08
NCT00002576
2001-01
NCT00003297
2001-01
NCT00003080
2001-05
NCT00199069
2001-05
14 further recorded trials
NCT00100477
2001-06
NCT00003957
2001-08
NCT00002544
2002-11
NCT00003068
2002-11
NCT00004197
2003-11-20
NCT00053131
2004-02
NCT00002835
2004-02-04
NCT00003215
2004-03
NCT00015951
2004-03
NCT00304291
2004-05
NCT00002598
2004-06
NCT00005802
2005-03
NCT00526305
2005-04
NCT00004237
2005-09
Q9
At the median, Mitoxantrone's trials enrolled 56 people — anything larger?
Median enrolment
56
Largest enrolment
2250
Registered trials counted
263
Q10
What do 1442 spontaneous reports say about Mitoxantrone — and not say?
These are reports people sent to a regulator. They do not show the medicine caused the reaction. Nobody counted how many people took the medicine and reported nothing. The same event can be reported more than once, and many reports are incomplete. News coverage, lawsuits and new warnings change how often people report. A count is not a rate and not a risk.
Mitoxantrone appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 1442 reaction mentions were counted: febrile neutropenia 440; neutropenia 213; pyrexia 145; thrombocytopenia 114. FAERS via Open Targets · CHEMBL1417019 · 2026-06-24
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febrile neutropenia
440
neutropenia
213
pyrexia
145
thrombocytopenia
114
sepsis
113
myelodysplastic syndrome
109
4 more recorded rows
acute myeloid leukaemia
82
ejection fraction decreased
81
pancytopenia
79
bone marrow failure
66
recorded 2026-06-24 · last checked 2026-09-04
Q11
Which 10 reactions does Mitoxantrone's label not list?
3 label terms; 10 reported and unlisted; accf9569-4b57-4e83-a7db-4e890a75d1ba
Show the evidence
acute myeloid leukaemia
count not stated
bone marrow failure
count not stated
ejection fraction decreased
count not stated
febrile neutropenia
count not stated
myelodysplastic syndrome
count not stated
neutropenia
count not stated
4 more recorded rows
pancytopenia
count not stated
pyrexia
count not stated
sepsis
count not stated
thrombocytopenia
count not stated
recorded 2026-06-24 · last checked 2026-09-04
Where it is registered
Where it’s registered
Withdrawn in United States, 2014, for "Failed Stability Specifications: Product is subpotent and has out of specification known and unknown impurities." (openFDA drug enforcement Class I recall)
ChEMBL 37 — CC BY-SA 3.0 Unported · ClinicalTrials.gov — US Government work · Open Targets 26.06 — CC0 · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work · openFDA enforcement — US Government work
✗ required summary fields resolved: 4 required field(s) not terminal: Why people use it, Best-supported result, Biggest unanswered question, Human evidence
✓ public claims reviewed: 0 reviewed claim(s); drafts are never rendered
✓ source coverage passed: 7 source rows
✓ no critical contamination: no quarantine open
✓ canonical metadata passed: slug and display name present
✓ no raw internal fields: enforced by the copy-contract test over the rendered page
This is a record of evidence. It is not medical advice, and it does not say this substance suits you. Nothing here says any substance on RNAWiki is appropriate for a child.