This page shows what was measured, who it was measured in, and what that does not settle.
What Thiotepa does in the body
The risk of graft rejection when used
From the FDA-approved label: Thiotepa is an alkylating drug of the polyfunctional type, related chemically and pharmacologically to the nitrogen mustard. The radiomimetic action of thiotepa is believed to occur through the release of ethyleneimine radicals which, like irradiation, disrupt the bonds of DNA. One of the principle bond disruptions is initiated by alkylation of guanine at the N-7 position, which severs the linkage between the purine base and the sugar and liberates alkylated guanines.
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 · 905Z5W3GKH · read 2026-08-29
Its recorded molecular formula is C6H12N3PS, weighing 189.23.
US prescribing information · a8c8bb14-0423-e4a3-8bf0-8a66ce05b1bb · read 2026-08-30
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 95 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.
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)
✗ The study did not show it
Who was studied
NCT04221035
How many people
800
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
Event free survival (EFS) (Arm A, B, D, and E)
✗ The study did not show it
Who was studied
NCT03126916
How many people
750
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
Event-free Survival Rate
✗ The study did not show it
Who was studied
NCT00567567
How many people
665
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
S9623, Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Women With Breast Cancer
✗ The study did not show it
Who was studied
NCT00002772
How many people
602
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
Standard Chemotherapy Compared With High-Dose Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Women With Breast Cancer
✗ The study did not show it
Who was studied
NCT00002755
How many people
600
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.
TEPADINA (thiotepa) is an alkylating drug indicated: To reduce the risk of graft rejection when used in conjunction with high-dose busulfan and cyclophosphamide as a preparative regimen for allogeneic hematopoietic progenitor (stem) cell transplantation (HSCT) for pediatric patients with class 3 beta-thalassemia. (1.1, 14) For treatment of adenocarcinoma of the breast or ovary.
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 pediatric, the label states: “Safety and effectiveness of thiotepa in neonates have not been established.”
US prescribing information · a8c8bb14-0423-e4a3-8bf0-8a66ce05b1bb · read 2026-08-30
On older people, the label states: “In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreasing hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.”
US prescribing information · a8c8bb14-0423-e4a3-8bf0-8a66ce05b1bb · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary Thiotepa can cause fetal harm when administered to a pregnant woman based on findings from animals and the drug’s mechanism of action [see Clinical Pharmacology (12.1 )] .”
US prescribing information · a8c8bb14-0423-e4a3-8bf0-8a66ce05b1bb · read 2026-08-30
On people who are breastfeeding, the label states: “8.3 Females and Males of Reproductive Potential Pregnancy testing Thiotepa can cause fetal harm when administered to a pregnant female.”
US prescribing information · a8c8bb14-0423-e4a3-8bf0-8a66ce05b1bb · read 2026-08-30
On people with reduced liver function, the label states: “Thiotepa is extensively metabolized in the liver.”
US prescribing information · a8c8bb14-0423-e4a3-8bf0-8a66ce05b1bb · read 2026-08-30
On people with reduced kidney function, the label states: “In patients with moderate (creatinine clearance (CLcr) of 30 mL/min to 59 mL/min) renal impairment, decreased renal excretion may result in increased plasma levels of thiotepa and TEPA [see Clinical Pharmacology (12.2) ] .”
US prescribing information · a8c8bb14-0423-e4a3-8bf0-8a66ce05b1bb · 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, S3, S4, S6.
No source is stored against this line.
What is in the pack
Sold as injectable, powder, solution, injection, powder, lyophilized, for solution, given by the injection, intracavitary, intravenous, intravesical, 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
25 products list this as an active ingredient in the United States drug directory. 25 of them contain it and nothing else.
FDA National Drug Code directory · 50683-0465 · read 2026-08-29
They are sold as injection, injection, powder, for solution, injection, powder, lyophilized, for solution and powder, taken intracavitary, intravenous and intravesical.
FDA National Drug Code directory · 50683-0465 · read 2026-08-29
The regulator's established pharmacologic class for it is alkylating activity [moa] and alkylating drug [epc].
FDA National Drug Code directory · 50683-0465 · read 2026-08-29
12 published labels name it as an active ingredient. 12 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · 559e353c-2dc0-16ba-e054-00144ff8d46c · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · 559e353c-2dc0-16ba-e054-00144ff8d46c · read 2026-08-29
Thiotepa is intracavitary at 3 DOSAGE FORMS AND STRENGTHS For injection: 15 mg, lyophilized white powder in single-dose vial for reconstitution., recorded as fda label in effect 2022-11-01 in the United States.
US prescribing information · a8c8bb14-0423-e4a3-8bf0-8a66ce05b1bb · 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 Thiotepa 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.
How much did people take in the studies?
The sources RNAWiki checked hold nothing for this field.
Why it matters. A result belongs to an amount. Without the amount the result floats free.
What would answer it
A stored source that records 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 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 Thiotepa 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
12 documents were read for this substance.
RNAWiki source record
Where else this substance is registered
FDA substance identifier (UNII)
905Z5W3GKH
RxNorm concept
1660004
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, S3, 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.
What the approval register records
16 approved applications cover products containing this substance. The earliest was NDA011683, approved 19590309 to IMMUNEX.
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 Thiotepa label: indicated for what?
"Thiotepa for injection is an alkylating drug indicated: • To reduce the risk of graft rejection when used in conjunction with high-dose busulfan and cyclophosphamide as a preparative regimen for allogeneic hematopoietic progenitor (stem) cell transplantation (HSCT) for pediatric patients with class 3 beta-thalassemia.…": indications and usage on Thiotepa's label. DailyMed label · 6cd6ae89-c553-4328-9262-4363610a1f19 · 2026-01-23
Q3
209 registered trials of Thiotepa — at which phases?
Registered studies posting no result
154 of 209
209 registered studies of Thiotepa: 144 phase2, 53 phase1, 24 phase3, 9 na, 3 early phase1, 1 na or unstated, 1 phase4. CLINICALTRIALS_SNAPSHOT · 2026-09-01
terminated; "no participants enrolled in a three year period"
NCT00003194
terminated; "Study enrollment did not meet expected goals"
NCT00003852
terminated; "lack of patient inclusion"
NCT00003926
terminated; "Withdrawn due to slow accrual"
NCT00006123
withdrawn; "Never started"
14 further recorded trials
NCT00066417
terminated; "Trial was withdrawn for drug availability issues."
NCT00593554
terminated; "Slow accrual"
NCT00621036
withdrawn; "MyVax did not meet its primary endpoints"
NCT00623077
terminated; "Replaced by another study"
NCT00801931
terminated; "Poor accrual"
NCT00914940
terminated; "Did not reach one of the primary endpoints of decreased total acute GVHD"
NCT00916045
terminated; "Recruitment issues"
NCT00972101
withdrawn; "Development of other studies led to termination without recruitment."
NCT01050764
terminated; "Safety"
NCT01350258
terminated; "Poor accrual"
NCT01598025
terminated; "Closed due to poor accrual"
NCT02199041
terminated; "The study was halted early due to slow accrual."
NCT02259348
terminated; "Investigator's decision."
NCT02653196
terminated; "The Principal Investigator left the institution."
recorded 2026-09-01 · last checked 2026-09-04
Q5
Thiotepa's half-life is 1.7 hours — which schedules were studied?
1.7 hours, the half-life Thiotepa's label states: "The mean terminal elimination half-life was 1.7 hours (64%) for thiotepa and 4 hours (29%) for its major active metabolite, N,N',N''-triethylenephosphoramide (TEPA) in pediatric population." DailyMed label · 6cd6ae89-c553-4328-9262-4363610a1f19 · 2026-01-23
Show the evidence
half lifepharmacokinetics
1.7 hours; The mean terminal elimination half-life was 1.7 hours (64%) for thiotepa and 4 hours (29%) for its major active metabolite, N,N',N''-triethylenephosphoramide (TEPA) in pediatric population.
metabolismpharmacokinetics
Metabolism Thiotepa undergoes hepatic metabolism.
recorded 2026-01-23 · last checked 2026-09-04
Q6
Which running trial of Thiotepa could settle lifespan?
NCT04217278 measures Overall survival (all randomisations), reading out 2026-05.
23 open trials; n 333; "A Trial of Treatments to Assess the Effects on Outcome of Adults With AML and MDS Undergoing Allogeneic SCT"
Show the evidence
Trial
NCT04217278
"A Trial of Treatments to Assess the Effects on Outcome of Adults With AML and MDS Undergoing Allogeneic SCT"; n 333; "Overall survival (all randomisations)"; 2026-05
NCT02605421
"Myeloablative Consolidation Therapy and Tandem Autologous Stem Cell Rescue in Patients With High-Risk Neuroblastoma"; n 12; "Progression Free Survival"; 2026-12
NCT01511562
"Combination Chemotherapy With or Without Autologous Stem Cell Transplant in Treating Patients With Central Nervous System B-Cell Lymphoma"; n 113; "Progression Free Survival"; 2027-05-02
NCT05303727
"Allogeneic Hematopoietic Stem Cell Transplantation for 4/M Neuroblastoma"; n 64; "overall survival(OS) at 3 year"; 2027-08
NCT01962415
"Reduced Intensity Conditioning for Non-Malignant Disorders Undergoing UCBT, BMT or PBSCT"; n 100; "Post-transplant treatment-related mortality (TRM)"; 2027-11
NCT04708054
"Venetoclax to Improve Outcomes of Fractionated Busulfan Regimen in Patients With High-Risk AML and MDS"; n 324; "1-year progression free survival (PFS)"; 2027-12-31
14 further recorded trials
NCT05088356
"Reduced Intensity Allogeneic HCT in Advanced Hematologic Malignancies w/T-Cell Depleted Graft"; n 66; "Determine the GVHD-free relapse-free survival (GRFS) post-HCT ( Arm-A)"; 2028-05
NCT02861417
"Busulfan, Fludarabine Phosphate, and Post-Transplant Cyclophosphamide in Treating Patients With Blood Cancer Undergoing Donor Stem Cell Transplant"; n 204; "Non-relapse mortality rate"; 2028-08-31
NCT06680661
"ABBA CORD: dCBT w/ Abatacept for aGVHD Prophylaxis"; n 20; "Severe aGVHD free survival"; 2028-10-31
NCT07441967
"The Safety and Efficacy of the Regimen of Thiotepa + Fludarabine +Granulocyte Colony-Stimulating Factor+ Cytarabine + Busulfan in Single Unrelated Umbilical Cord Blood Transplantation"; n 44; "180-day non-recurrence mortality rate"; 2028-12-30
NCT06900192
"A Study of Allogeneic Hematopoietic Cell Transplantation for Primary Progressive Multiple Sclerosis"; n 10; "Severe acute Graft-versus-Host-Disease-free survival"; 2029-08
NCT07276737
"Preconditioning With a Combination of Thiotepa, Cyclophosphamide, and Busulfan for Allogeneic Hematopoietic Stem Cell Transplantation in the Treatment of NK/T-Cell Lymphoma"; n 37; "progression free survival"; 2029-12-30
NCT03970096
"Graft Versus Host Disease-Reduction Strategies for Donor Blood Stem Cell Transplant Patients With Acute Leukemia or Myelodysplastic Syndrome (MDS)"; n 120; "Graft versus host disease (GVHD)-free relapse-free survival (RFS)"; 2029-12-31
NCT06172296
"Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma"; n 478; "Event free survival (EFS)"; 2029-12-31
NCT01949129
"Allogeneic Stem Cell Transplantation for Children and Adolescents With Acute Lymphoblastic Leukaemia"; n 1800; "Overall Survival (OS) Stratum 1a (randomisation TBI+ chemo-conditioning vs. chemo-conditioning only)"; 2030-04
NCT07566377
"Cord Blood Transplantation in Children and Young Adults With Blood Cancer"; n 71; "Disease-free Survival (DFS)"; 2030-04-28
NCT07563920
"TBF Conditioning Regimen for Haploidentical Stem Cell Transplantation in Elderly AML Patients in First Complete Remission"; n 93; "1-year Relapse-Free Survival (RFS)"; 2030-06
NCT03126916
"Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL)"; n 750; "Event free survival (EFS) (Arm A, B, D, and E)"; 2030-09-30
NCT07565220
"Thiotepa-based Conditioning Regimen With De-escalated Post-graft Cyclophosphamide for Allogeneic Stem Cell Transplantation in Hematologic Malignancies"; n 48; "GVHD-free, relapse-free survival (GRFS)"; 2030-11-01
NCT07052370
"TCRαβ-depleted Progenitor Cell Graft With Early Memory T-cell DLI, Plus Selected Use of Blinatumomab, in naïve T-cell Depleted Haploidentical Donor Hematopoietic Cell Transplantation for Hematologic Malignancies"; n 30; "Number of participants experiencing grade 3-4 GVHD and/or transplant related mortality (TRM)."; 2030-12
Q7
Which 56 trials of Thiotepa posted no result?
Posted no result
56 of 56 completed trials
Registrations
NCT00002755, NCT00003398, NCT00002680, NCT00003877, NCT00003297 and NCT00003080, and 50 more
Completion dates
oldest 1999-06; newest 2024-06-30
Show the evidence
Trial
NCT00002755
1999-06
NCT00003398
2000-05
NCT00002680
2000-12
NCT00003877
2000-12
NCT00003297
2001-01
NCT00003080
2001-05
14 further recorded trials
NCT00003146
2001-06
NCT00004906
2001-06
NCT00003899
2001-11
NCT00002870
2002-01
NCT00003081
2002-01
NCT00003101
2002-01
NCT00005092
2002-08-28
NCT00003068
2002-11
NCT00002471
2003-01
NCT00003972
2003-03
NCT00002534
2003-04
NCT00003173
2003-05
NCT00004172
2003-10
NCT00004900
2004-08
Q8
At the median, Thiotepa's trials enrolled 40 people — anything larger?
Median enrolment
40
Largest enrolment
1800
Registered trials counted
193
Q9
What do 1788 spontaneous reports say about Thiotepa — 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.
Thiotepa appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 1788 reaction mentions were counted: febrile neutropenia 339; mucosal inflammation 277; cytomegalovirus infection 222; pyrexia 182. FAERS via Open Targets · CHEMBL671 · 2026-06-24
Show the evidence
febrile neutropenia
339
mucosal inflammation
277
cytomegalovirus infection
222
pyrexia
182
acute graft versus host disease
139
human herpesvirus 6 infection
134
4 more recorded rows
thrombocytopenia
134
neutropenia
130
acute graft versus host disease in skin
123
sepsis
108
recorded 2026-06-24 · last checked 2026-09-04
Q10
Which 10 reactions does Thiotepa's label not list?
acute graft versus host disease, acute graft versus host disease in skin and cytomegalovirus infection and 7 more reported for Thiotepa, absent from its label. FAERS via Open Targets · CHEMBL671 · 2026-06-24
2 label terms; 10 reported and unlisted; 6cd6ae89-c553-4328-9262-4363610a1f19
Show the evidence
acute graft versus host disease
count not stated
acute graft versus host disease in skin
count not stated
cytomegalovirus infection
count not stated
febrile neutropenia
count not stated
human herpesvirus 6 infection
count not stated
mucosal inflammation
count not stated
4 more recorded rows
neutropenia
count not stated
pyrexia
count not stated
sepsis
count not stated
thrombocytopenia
count not stated
recorded 2026-06-24 · last checked 2026-09-04
Q11
Thiotepa and CYP3A4, CYP2B6 and CYP3A: shared by which compounds?
7.1 Effect of Cytochrome CYP3A Inhibitors and Inducers In vitro studies suggest that thiotepa is metabolized by CYP3A4 and CYP2B6 to its active metabolite TEPA.
drug_interactions
Avoid coadministration of strong CYP3A4 inhibitors (e.g., itraconazole, clarithromycin, ritonavir) and strong CYP3A4 inducers (e.g., rifampin, phenytoin) with thiotepa due to the potential effects on efficacy and toxicity [see Clinical Pharmacology (12.2) ] .
drug_interactions
Consider alternative medications with no or minimal potential to inhibit or induce CYP3A4.
drug_interactions
If concomitant use of strong CYP3A4 modulators cannot be avoided, closely monitor for adverse drug reactions.
drug_interactions
7.2 Effect of Thiotepa on Cytochrome CYP2B6 Substrates In vitro studies suggest that thiotepa inhibits CYP2B6.
drug_interactions
Thiotepa may increase the exposure of drugs that are substrates of CYP2B6 in patients; however, the clinical relevance of this in vitro interaction is unknown [see Clinical Pharmacology (12.2) ] .
2 more recorded rows
Interaction statementpharmacokinetics
In vitro data suggests that CYP3A4 and CYP2B6 may be responsible for the metabolism of thiotepa to TEPA, a major active metabolite.
Interaction statementpharmacokinetics
Drug Interactions The clinical relevance of in vitro inhibition of the cytochrome P450 enzymes described below is unknown, but it cannot be excluded that the systemic exposure of thiotepa or medicinal products that are substrates for these enzymes may be affected with concomitant administration with thiotepa.
ChEMBL 37 — CC BY-SA 3.0 Unported · ChEMBL ATC CC BY-SA · 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
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✓ source coverage passed: 5 source rows
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