This page shows what was measured, who it was measured in, and what that does not settle.
What .GAMMA.-HYDROXY Bendamustine does in the body
Chronic lymphocytic leukemia
From the FDA-approved label: Bendamustine is a bifunctional mechlorethamine derivative containing a purine-like benzimidazole ring. Mechlorethamine and its derivatives form electrophilic alkyl groups. These groups form covalent bonds with electron-rich nucleophilic moieties, resulting in interstrand DNA crosslinks. The bifunctional covalent linkage can lead to cell death via several pathways. Bendamustine is active against both quiescent and dividing cells. The exact mechanism of action of bendamustine remains unknown.
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
Its recorded molecular formula is C16H21Cl2N3O2∙HCl, weighing 412.74.
US prescribing information · 4df6548f-c4ad-4eb2-a54f-19766a3d90ca · 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 83 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.
Progression-Free Survival in the Follicular Lymphoma Population, Investigator-Assessed
✗ The study did not show it
Who was studied
NCT01332968
How many people
1401
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. Intravenous
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
Progression free survival
✗ The study did not show it
Who was studied
NCT00877214
How many people
1272
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. Intravenous
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
Arm A1 vs Arm B: Percentage of Participants who Achieve Complete Response rate at 30 months (CR30)
✗ The study did not show it
Who was studied
NCT06191744
How many people
1095
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. Intravenous
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
COMPLETE RESPONSE RATE
✗ The study did not show it
Who was studied
NCT01650701
How many people
1030
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. Intravenous
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
Complete Response Rate (CR/CRu) at 120 Weeks by Independent Central Review
✗ The study did not show it
Who was studied
NCT01476787
How many people
1030
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. Intravenous
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
SRI Primary: Incidence, nature and severity of AEs and SAEs. Incidence and nature of study drug discontinuations, dose reductions, and dose delays due to AEs
✗ The study did not show it
Who was studied
NCT06549595
How many people
1018
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. Intravenous
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.
Bendamustine Hydrochloride Injection is an alkylating drug indicated for treatment of adult patients with: • Chronic lymphocytic leukemia (CLL). Efficacy relative to first line therapies other than chlorambucil has not been established. ( 1.1 ) • Indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.
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 in pediatric patients have not been established.”
US prescribing information · 4df6548f-c4ad-4eb2-a54f-19766a3d90ca · read 2026-08-30
On older people, the label states: “No overall differences in safety were observed between patients ≥65 years of age and younger patients.”
US prescribing information · 4df6548f-c4ad-4eb2-a54f-19766a3d90ca · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary In animal reproduction studies, intraperitoneal administration of bendamustine to pregnant mice and rats during organogenesis at doses 0.6 to 1.8 times the maximum recommended human dose (MRHD) resulted in embryo-fetal and/or infant mortality, structural abnormalities, and alterations to growth (see Data).”
US prescribing information · 4df6548f-c4ad-4eb2-a54f-19766a3d90ca · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary There are no data on the presence of bendamustine hydrochloride or its metabolites in either human or animal milk, the effects on the breastfed child, or the effects on milk production.”
US prescribing information · 4df6548f-c4ad-4eb2-a54f-19766a3d90ca · read 2026-08-30
On people with reduced liver function, the label states: “Do not use VIVIMUSTA in patients with AST or ALT 2.5 to 10 times upper limit of normal (ULN) and total bilirubin 1.5 to 3 times ULN or total bilirubin greater than 3 times ULN [see Clinical Pharmacology ( 12.3 )]”
US prescribing information · 4df6548f-c4ad-4eb2-a54f-19766a3d90ca · read 2026-08-30
On people with reduced kidney function, the label states: “Do not use VIVIMUSTA in patients with creatinine clearance (CLcr) less than 30 mL/min [see Clinical Pharmacology ( 12.3 )].”
US prescribing information · 4df6548f-c4ad-4eb2-a54f-19766a3d90ca · 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
Given by a clinician
❝ 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
Intravenous
✎ 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.
No source is stored against this line.
What is in the pack
Sold as powder, solution, injectable, injection, solution, given by the intravenous, iv (infusion), injection 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
Intravenous
✎ 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
31 products list this as an active ingredient in the United States drug directory. 31 of them contain it and nothing else.
FDA National Drug Code directory · 17337-0306 · read 2026-08-29
They are sold as injection, injection, powder, lyophilized, for solution, injection, solution and powder, taken intravenous.
FDA National Drug Code directory · 17337-0306 · 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 · 17337-0306 · 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 · 4df6548f-c4ad-4eb2-a54f-19766a3d90ca · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · 4df6548f-c4ad-4eb2-a54f-19766a3d90ca · read 2026-08-29
VIVIMUSTA is intravenous at 3 DOSAGE FORMS & STRENGTHS Injection: 100 mg/4 mL (25 mg/mL) as a clear and colorless to yellow solution in multiple-dose vial., recorded as fda label in effect 2025-04-03 in the United States.
US prescribing information · 4df6548f-c4ad-4eb2-a54f-19766a3d90ca · 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 .GAMMA.-HYDROXY Bendamustine 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 .GAMMA.-HYDROXY Bendamustine 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.
◇Read from sources, not yet reviewed
No traced study record is stored for this substance.
Built from stored sources by fixed rules. No reviewer has signed it off.
How many documents were read
12 documents were read for this substance.
RNAWiki source record
12 of them state the same volumeOfDistribution, and they agree.
RNAWiki source record
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.
✓ 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
21 approved applications cover products containing this substance. The earliest was NDA022249, approved 20080320 to CEPHALON.
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 (9)
Q2
On the .GAMMA.-HYDROXY Bendamustine label: indicated for what?
"Bendamustine Hydrochloride Injection is an alkylating drug indicated for treatment of adult patients with: Chronic lymphocytic leukemia (CLL). Efficacy relative to first line therapies other than chlorambucil has not been established.": indications and usage on .GAMMA.-HYDROXY Bendamustine's label. DailyMed label · f359e7c6-d104-457d-a7fe-597c74440353 · 2026-05-14
Q3
310 registered trials of .GAMMA.-HYDROXY Bendamustine — at which phases?
Registered studies posting no result
193 of 310
310 registered studies of .GAMMA.-HYDROXY Bendamustine: 173 phase2, 118 phase1, 65 phase3, 6 na or unstated, 3 phase4, 1 early phase1. CLINICALTRIALS_SNAPSHOT · 2026-09-01
"Funding was withdrawn due to insufficient accrual"; 52 of 310 registered studies
Show the evidence
Trial
NCT00758693
withdrawn; "Funding was withdrawn due to insufficient accrual"
NCT00790855
terminated; "Lack of Response"
NCT00872976
withdrawn; "Business Objectives Changed"
NCT00879073
terminated; "Principal Investigator is leaving Moffitt"
NCT00899431
terminated; "Terminated per PI's request at the time of continuing review"
NCT00901927
terminated; "Study was closed early due to toxicity"
14 further recorded trials
NCT00939328
withdrawn; "question was no longer committee priority"
NCT00947388
terminated; "No more eligible patients"
NCT01010568
terminated; "Unable to accrue patients due to change in standard CLL therapy"
NCT01170052
withdrawn; "insufficient enrollment"
NCT01177683
terminated; "Lack of accrual"
NCT01238146
withdrawn; "No patients accrued."
NCT01315873
terminated; "PI left the institution before all data analysis was completed"
NCT01332617
withdrawn; "Investigators no longer interested in activating study"
NCT01352312
terminated; "Insufficient accrual over 12 mo period"
NCT01423539
withdrawn; "The NAVIGATE study has been terminated due to non-safety related reasons."
NCT01438177
terminated; "PI left institution."
NCT01484626
terminated; "Celgene would no longer supply lenalidomide for the study"
NCT02002598
terminated; "Slow accrual and loss of funding"
NCT02008006
terminated; "Insufficient recruitment and unavailability of the treatment"
recorded 2026-09-01 · last checked 2026-09-04
Q5
Human studies of .GAMMA.-HYDROXY Bendamustine used 15 mg/kg TRU-016 and bendamustine — over how long?
studies of .GAMMA.-HYDROXY Bendamustine used the recorded amount. ClinicalTrials.gov · 2026-09-01
4 recorded entries; human; also "15 mg/kg TRU-016 and bendamustine", "20 mg/kg TRU-016 and bendamustine", "Bendamustine at a dose of 100 mg/m2"
Show the evidence
human
NCT01188681
15 mg/kg TRU-016 and bendamustine
NCT01188681
20 mg/kg TRU-016 and bendamustine
NCT01500083
Bendamustine at a dose of 100 mg/m2
NCT01500083
Bendamustine at a dose of 120 mg/m2
recorded 2026-09-01 · last checked 2026-09-04
Q6
.GAMMA.-HYDROXY Bendamustine's half-life is 1 hour — which schedules were studied?
1 hour, the half-life .GAMMA.-HYDROXY Bendamustine's label states: "Elimination After a single intravenous dose of 120 mg/m 2 of bendamustine over 1 hour, the intermediate half-life (t ½ ) of the parent compound is approximately 40 minutes." DailyMed label · f359e7c6-d104-457d-a7fe-597c74440353 · 2026-05-14
Show the evidence
half lifepharmacokinetics
1 hour; Elimination After a single intravenous dose of 120 mg/m 2 of bendamustine over 1 hour, the intermediate half-life (t ½ ) of the parent compound is approximately 40 minutes.
metabolismpharmacokinetics
Metabolism Bendamustine is extensively metabolized via hydrolytic, oxidative, and conjugative pathways.
recorded 2026-05-14 · last checked 2026-09-04
Q7
Which running trial of .GAMMA.-HYDROXY Bendamustine could settle lifespan?
NCT05506410 measures progression free survival（PFS）, reading out 2026-12-30.
26 open trials; n 100; "A Clinical Study of Hanlikang and BTK Inhibitors in the Treatment of Newly Diagnosed Mantle Cell Lymphoma"
Show the evidence
Trial
NCT05506410
"A Clinical Study of Hanlikang and BTK Inhibitors in the Treatment of Newly Diagnosed Mantle Cell Lymphoma"; n 100; "progression free survival（PFS）"; 2026-12-30
NCT02972840
"A Study of BR Alone Versus in Combination With Acalabrutinib in Subjects With Previously Untreated MCL"; n 635; "Progression-free survival per the Lugano Classification for NHL in Arm 1 compared to Arm 2"; 2027-02-15
NCT04666038
"Study of LOXO-305 (Pirtobrutinib) Versus Investigator's Choice (Idelalisib Plus Rituximab or Bendamustine Plus Rituximab) in Patients With Previously Treated Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)"; n 238; "Progression-free Survival (PFS) Assessed by Independent Review Committee (IRC)"; 2027-05
NCT06931613
"Autologous Hematopoietic Stem Cell Transplantation in Pediatric Relapsed or Refractory Hodgkin Lymphoma After Nivolumab Treatment"; n 20; "Event free survival"; 2027-06-01
NCT01886872
"Rituximab and Bendamustine Hydrochloride, Rituximab and Ibrutinib, or Ibrutinib Alone in Treating Older Patients With Previously Untreated Chronic Lymphocytic Leukemia"; n 547; "Progression Free Survival (PFS)"; 2027-06-24
NCT04913103
"Study of PV in Combination With Bendamustine and Rituximab for Patients With R/R MCL"; n 21; "Progression-free survival (PFS)"; 2027-08-31
14 further recorded trials
NCT05023980
"A Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab (BR) in Untreated Patients With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)"; n 309; "To evaluate progression-free survival (PFS) of pirtobrutinib (Arm A) compared to bendamustine and rituximab (Arm B)"; 2027-10
NCT02970318
"A Study of Acalabrutinib vs Investigator's Choice of Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in R/R CLL"; n 310; "Progression-free Survival (PFS) Per Independent Review Committee (IRC) Assessment"; 2027-10-01
NCT03336333
"A Study Comparing Zanubrutinib With Bendamustine Plus Rituximab in Participants With Previously Untreated CLL or SLL"; n 590; "Cohort 1: Progression-free Survival (PFS) as Determined by Independent Central Review (ICR)"; 2027-10-31
NCT06084936
"A Study to Evaluate Glofitamab as a Single Agent vs. Investigator's Choice in Participants With Relapsed/Refractory Mantle Cell Lymphoma"; n 182; "Progression-free survival (PFS)"; 2028-03-31
NCT06522737
"A Study of Duvelisib Versus Gemcitabine or Bendamustine in Participants With Relapsed/Refractory Nodal T Cell Lymphoma With T Follicular Helper (TFH) Phenotype"; n 124; "Progression-free Survival (PFS) as assessed by the Independent Review Committee (IRC)"; 2028-12
NCT06477549
"BeFluBu vs FluBuRux Conditioning in Haploidentical HCT"; n 220; "Event-free survival"; 2029-06
NCT06465446
"A Study of IMM01 Plus Tiselizumab Versus Physician's Choice Chemotherapy in PD(L)1-refractory Classical Hodgkin Lymphoma"; n 202; "Progression Free Survival (PFS) per Lugano 2014 as Assessed by Independent Review Committee (IRC)"; 2029-07
NCT06970743
"A Study of BGB-16673 Compared to Investigator's Choice in Participants With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Covalent Bruton Tyrosine Kinase (BTK) Inhibitors"; n 153; "Progression-Free Survival (PFS) by IRC"; 2029-11-30
NCT07139873
"A Study of DZD8586 Versus Investigator's Choice in r/r CLL/SLL (TAI-SHAN6)"; n 250; "Progression free survival (PFS) assessed by Independent Review Committee (IRC)"; 2029-12
NCT06846671
"A Study of Tacabrutideg (BGB-16673) Compared to Investigator's Choice in Participants With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Both Bruton Tyrosine Kinase (BTK) and B-cell Leukemia/Lymphoma 2 Protein (BCL2) Inhibitors"; n 250; "Progression-Free Survival (PFS) by Independent Review Committee (IRC)"; 2030-02-14
NCT06911502
"A Study to Compare the Efficacy and Safety of Golcadomide in Combination With Rituximab (Golca + R) vs Investigator's Choice in Participants With Relapsed/Refractory Follicular Lymphoma Who Have Received at Least 1 Prior Line of Systemic Therapy (GOLSEEK-4)"; n 400; "Progression free survival (PFS) assessed by Independent Review Adjudication committee (IRAC)"; 2030-07-31
NCT05371093
"Study of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Participants With Relapsed/Refractory Follicular Lymphoma"; n 231; "Progression-free Survival (PFS) as Assessed by Blinded Central Assessment per Lugano Classification"; 2030-10
NCT06961500
"Obinutuzumab With CHOP Versus Obinutuzumab With Bendamustine in the Treatment of Newly Diagnosed Follicular Lymphoma Grade 3A"; n 133; "Progression-Free Survival (PFS)"; 2030-11-01
NCT07753369
"A Clinical Trial to Evaluate the Efficacy and Safety of TQB3909 Tablets Versus Investigator's Choice in the Treatment of Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)"; n 128; "Progression free survival (PFS) evaluated by an independent review committee (IRC)"; 2030-12
Q8
Which 64 trials of .GAMMA.-HYDROXY Bendamustine posted no result?
Posted no result
64 of 64 completed trials
Registrations
NCT00389051, NCT01423032, NCT00991211, NCT00612183, NCT00139841 and NCT00274963, and 58 more
Completion dates
oldest 2007-10-26; newest 2024-05-30
Show the evidence
Trial
NCT00389051
2007-10-26
NCT01423032
2009-05
NCT00991211
2009-08
NCT00612183
2009-09
NCT00139841
2009-10
NCT00274963
2009-10
14 further recorded trials
NCT00863850
2010-03
NCT00794638
2010-05
NCT00274989
2011-03
NCT00661739
2011-05
NCT00951457
2012-08-06
NCT00959686
2013-02
NCT01109264
2013-08
NCT00831597
2013-09
NCT01152203
2014-05
NCT00864942
2014-10
NCT00837928
2015-01-08
NCT01042704
2015-03
NCT01929265
2015-05
NCT00740415
2015-08
Q9
At the median, .GAMMA.-HYDROXY Bendamustine's trials enrolled 49 people — anything larger?
Median enrolment
49
Largest enrolment
1401
Registered trials counted
309
Q10
.GAMMA.-HYDROXY Bendamustine and CYP1A2, CYP2A6 and CYP2B6: shared by which compounds?
Consider alternative therapies that are not CYP1A2 inducers or inhibitors during treatment with Bendamustine Hydrochloride Injection.
drug_interactions
( 7.1 ) 7.1 Effect of Other Drugs on Bendamustine Hydrochloride Injection CYP1A2 Inhibitors The coadministration of Bendamustine Hydrochloride Injection with CYP1A2 inhibitors may increase bendamustine plasma concentrations and may result in increased incidence of adverse reactions with Bendamustine Hydrochloride Injection [see Clinical Pharmacology (12.3) ] .
drug_interactions
Consider alternative therapies that are not CYP1A2 inhibitors during treatment with Bendamustine Hydrochloride Injection.
drug_interactions
CYP1A2 Inducers The coadministration of Bendamustine Hydrochloride Injection with CYP1A2 inducers may decrease bendamustine plasma concentrations and may result in decreased efficacy of Bendamustine Hydrochloride Injection [see Clinical Pharmacology (12.3) ] .
drug_interactions
Consider alternative therapies that are not CYP1A2 inducers during treatment with Bendamustine Hydrochloride Injection.
pharmacokinetics
Two active minor metabolites, M3 and M4, are primarily formed via CYP1A2 in vitro .
2 more recorded rows
Interaction statementpharmacokinetics
Drug Interaction Studies In Vitro Studies Effect of Bendamustine on CYP Substrates Bendamustine did not inhibit CYP1A2, 2C9/10, 2D6, 2E1, or 3A4/5.
Interaction statementpharmacokinetics
Bendamustine did not induce metabolism of CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2E1, or CYP3A4/5.
ClinicalTrials.gov — US Government work · 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
✓ no critical contamination: no quarantine open
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