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Fludarabine

  • Prescription medicine
  • Prescription only
  • Identity checked
  • Sources last checked 2026-09-04

This page shows what was measured, who it was measured in, and what that does not settle.

What Fludarabine does in the body

Fludarabine Phosphate Injection is a nucleotide metabolic inhibitor indicated for: The treatment of adult patients with B-cell chronic lymphocytic leukemia (CLL) who have not responded to or whose disease has progressed during treatment with at least one standard alkylating-agent containing regimen.

From the FDA-approved label: Fludarabine phosphate is rapidly dephosphorylated to 2-fluoro-ara-A and then phosphorylated intracellularly by deoxycytidine kinase to the active triphosphate, 2-fluoro-ara-ATP. This metabolite appears to act by inhibiting DNA polymerase alpha, ribonucleotide reductase and DNA primase, thus inhibiting DNA synthesis. The mechanism of action of this antimetabolite is not completely characterized and may be multi-faceted.

Why people take it. Fludarabine Phosphate Injection is a nucleotide metabolic inhibitor indicated for: The treatment of adult patients with B-cell chronic lymphocytic leukemia (CLL) who have not responded to or whose disease has progressed during treatment with at least one standard alkylating-agent containing regimen.

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 · P2K93U8740 · read 2026-08-29

Where each sentence above came from

The use the label states, quoted from it. No plain-language version of this sentence has been written.

The use the label states, quoted from it. It is written for a clinician, not for a reader without medical training.

No statement of the main limit is recorded.

The four opening statements run to 150 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 peopleRead 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.

Event-free survival

The study did not show it

Who was studied
NCT01117441
How many people
6136
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

The study did not show it

Who was studied
NCT03643276
How many people
5000
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

Timing of treatment Substudy or Tier Advancement Pathway (TAP) assignment

The study did not show it

Who was studied
NCT05564390
How many people
2000
Study design
Phase 2
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

Overall survival

The study did not show it

Who was studied
NCT00454480
How many people
2000
Study design
Phase 2/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

Remission rate

The study did not show it

Who was studied
NCT00198991
How many people
1883
Study design
Phase 4
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

Overall Survival (OS) Stratum 1a (randomisation TBI+ chemo-conditioning vs. chemo-conditioning only)

The study did not show it

Who was studied
NCT01949129
How many people
1800
Study design
Phase 2/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
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 unclearRead 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.

  • Fludarabine Phosphate Injection is a nucleotide metabolic inhibitor indicated for: The treatment of adult patients with B-cell chronic lymphocytic leukemia (CLL) who have not responded to or whose disease has progressed during treatment with at least one standard alkylating-agent containing regimen. Benefit in treatment-naïve or non-refractory CLL patients is not established.

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: “Fludarabine phosphate was evaluated in 62 pediatric patients (median age 10, range 1 to 21) with refractory acute leukemia (45 patients) or solid tumors (17 patients).”

    US prescribing information · 20e5acf0-90b7-45c8-be78-91eaf77c9ac0 · read 2026-08-30

  • On people who are pregnant, the label states: “Teratogenic Effects Pregnancy Category D [see Warnings and Precautions ( 5.6 )].”

    US prescribing information · 20e5acf0-90b7-45c8-be78-91eaf77c9ac0 · read 2026-08-30

  • On people who are breastfeeding, the label states: “It is not known whether fludarabine phosphate is excreted in human milk.”

    US prescribing information · 20e5acf0-90b7-45c8-be78-91eaf77c9ac0 · 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 takeRead 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 takeRead 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.

No source is stored against this line.

What is in the pack

Sold as injectable, tablet, injection, powder, lyophilized, for solution, injection, solution, given by the injection, oral, 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 takeNothing 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 unclearRead 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

  • 9 products list this as an active ingredient in the United States drug directory. 9 of them contain it and nothing else.

    FDA National Drug Code directory · 0527-1242 · 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 · 0527-1242 · read 2026-08-29

  • The regulator's established pharmacologic class for it is nucleic acid synthesis inhibitors [moa] and nucleoside metabolic inhibitor [epc].

    FDA National Drug Code directory · 0527-1242 · read 2026-08-29

  • 5 published labels name it as an active ingredient. 5 of them describe this substance alone, which is where its own label text on this page comes from.

    US prescribing information · 20e5acf0-90b7-45c8-be78-91eaf77c9ac0 · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · 20e5acf0-90b7-45c8-be78-91eaf77c9ac0 · read 2026-08-29

  • Fludarabine Phosphate is intravenous at 3 DOSAGE FORMS AND STRENGTHS Fludarabine Phosphate Injection, USP is supplied as a 50 mg per 2 mL (25 mg per mL) sterile solution., recorded as fda label in effect 2021-07-22 in the United States.

    US prescribing information · 20e5acf0-90b7-45c8-be78-91eaf77c9ac0 · 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 takeRead 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 Fludarabine 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 unclearRead 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 Fludarabine 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 peopleRead 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

  • 5 documents were read for this substance.

    RNAWiki source record

  • 5 of them state the same halfLife, and they agree.

    RNAWiki source record

  • 5 of them state the same proteinBinding, and they agree.

    RNAWiki source record

Where else this substance is registered

FDA substance identifier (UNII)
P2K93U8740
CAS registry number
21679-14-1
PubChem compound
657237
ChEMBL
CHEMBL1096882
WHO international nonproprietary name list entry
5214
RxNorm concept
24698
EMA substance identifier
100000081235
European Chemicals Agency number
244-525-5
DrugBank
DB01073

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: Quoted from a stored source.

  • 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 unclearRead 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

  • 14 approved applications cover products containing this substance. The earliest was NDA020038, approved 19910418 to GENZYME CORP.

    Drugs@FDA application register · NDA020038 · read 2026-08-29

  • Marketing status on the register: discontinued and prescription.

    Drugs@FDA application register · NDA020038 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 20051211.

    FDA National Drug Code directory · 0527-1242 · read 2026-08-29

What is missing or unclearRead from sources, not yet reviewed

What to learn next

Ordered by what would most change how you read this page, starting with what is easiest to misunderstand.

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)

On the Fludarabine label: indicated for what?


"Fludarabine Phosphate Injection is a nucleotide metabolic inhibitor indicated for: The treatment of adult patients with B-cell chronic lymphocytic leukemia (CLL) who have not responded to or whose disease has progressed during treatment with at least one standard alkylating-agent containing regimen. Benefit in…": indications and usage on Fludarabine's label. DailyMed label · 8039c2e3-ffe5-3997-e053-2991aa0ad9d0 · 2023-02-14

1549 registered trials of Fludarabine — at which phases?


Registered studies posting no result
1073 of 1549

1549 registered studies of Fludarabine: 857 phase2, 747 phase1, 108 phase3, 56 na, 45 early phase1, 18 phase4, 14 na or unstated. CLINICALTRIALS_SNAPSHOT · 2026-09-01

1403 with a PubMed record

Show the evidence
  • phase2
    857
  • phase1
    747
  • phase3
    108
  • na
    56
  • early phase1
    45
  • phase4
    18
13 more recorded rows
  • na or unstated
    14
  • completed
    566
  • recruiting
    283
  • terminated
    258
  • active not recruiting
    141
  • unknown
    141
  • withdrawn
    76
  • not yet recruiting
    62
  • suspended
    14
  • no longer available
    4
  • enrolling by invitation
    2
  • approved for marketing
    1
  • available
    1

recorded 2026-09-01 · last checked 2026-09-04

308 of Fludarabine's trials stopped: safety, futility/efficacy, accrual/recruitment, funding/business, sponsor decision unspecified, other?


safety (17), futility/efficacy (11), accrual/recruitment (121), funding/business (30), sponsor decision unspecified (13) and other (116): Fludarabine's stop wording, clustered. CLINICALTRIALS_SNAPSHOT · 2026-09-01

"low accrual"; 308 of 1549 registered studies

Show the evidence

Trial

  • NCT00003729
    terminated; "low accrual"
  • NCT00004114
    withdrawn; "Study never opened"
  • NCT00004878
    withdrawn; "study never opened"
  • NCT00006126
    withdrawn; "Unable to accrue subjects."
  • NCT00034528
    terminated; "Due to slow recruitment"
  • NCT00040417
    terminated; "unable to accrue patients"
14 further recorded trials
  • NCT00041288
    terminated; "Poor accrual and difficulty with multicenter logistics"
  • NCT00048399
    terminated; "accrual was slow"
  • NCT00048893
    terminated; "The study was closed to accrual due to very poor enrollment."
  • NCT00053014
    terminated; "Poor accrual"
  • NCT00058825
    terminated; "Slow accrual due to practice changes meant study would take too long to finish"
  • NCT00066417
    terminated; "Trial was withdrawn for drug availability issues."
  • NCT00069992
    terminated; "Closed due to competing protocols"
  • NCT00074269
    terminated; "Terminated early due to poor enrollment"
  • NCT00074490
    terminated; "Premature closure due to inability to accrue to ARM IVD, cohorts 1 and 2"
  • NCT00085449
    withdrawn; "Funding cut, no patients enrolled"
  • NCT00091611
    terminated; "This study was terminated due to low accrual."
  • NCT00119366
    terminated; "Funding ended before target accrual was reached; participants are no longer being examined or receiving intervention."
  • NCT00121186
    terminated; "poor accrual"
  • NCT00167180
    terminated; "Accrual Goal Met"

recorded 2026-09-01 · last checked 2026-09-04

Human studies of Fludarabine used Fludarabine on day 2-6, 25 mg/m^2 day x 5 days administered as an intravenous push or intravenous piggyback over 10-30 minutes, repeated every 28 days. — over how long?


studies of Fludarabine used the recorded amount. ClinicalTrials.gov · 2026-09-01

5 recorded entries; human; intravenous; also "Fludarabine on day 2-6, 25 mg/m^2 day x 5 days administered as an intravenous push or intravenous piggyback over 10-30…", "Fludarabine phosphate 40 mg", "Fludarabine phosphate 30 mg"

Show the evidence

human

  • NCT00001586
    intravenous; Fludarabine on day 2-6, 25 mg/m^2 day x 5 days administered as an intravenous push or intravenous piggyback over 10-30 minutes, repeated every 28 days.
  • NCT01652092
    Fludarabine phosphate 40 mg
  • NCT01652092
    Fludarabine phosphate 30 mg
  • NCT04545762
    Fludarabine 30mg/m2
  • NCT05108805
    Fludarabine 30 mg/m^2/day

recorded 2026-09-01 · last checked 2026-09-04

Fludarabine's half-life is 20 hours — which schedules were studied?


20 hours, the half-life Fludarabine's label states: "The terminal half-life of 2-fluoro-ara-A was estimated as approximately 20 hours." DailyMed label · 8039c2e3-ffe5-3997-e053-2991aa0ad9d0 · 2023-02-14

Show the evidence
  • half life pharmacokinetics
    20 hours; The terminal half-life of 2-fluoro-ara-A was estimated as approximately 20 hours.

recorded 2023-02-14 · last checked 2026-09-04

Which running trial of Fludarabine could settle lifespan?


NCT03121014 measures Relapse free survival of approximately 30% in high-risk patients conditioned with the Fludarabine/ Busulfan regimen, reading out 2026-04.

73 open trials; n 38; "Study of Intensity Modulated Total Marrow Irradiation (IM-TMI) in Addition to Fludarabine/Busulfan Conditioning for Allogeneic Transplantation in High Risk AML and Myelodysplastic Syndromes"

Show the evidence

Trial

  • NCT03121014
    "Study of Intensity Modulated Total Marrow Irradiation (IM-TMI) in Addition to Fludarabine/Busulfan Conditioning for Allogeneic Transplantation in High Risk AML and Myelodysplastic Syndromes"; n 38; "Relapse free survival of approximately 30% in high-risk patients conditioned with the Fludarabine/ Busulfan regimen"; 2026-04
  • 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
  • NCT02048813
    "Ibrutinib and Rituximab Compared With Fludarabine Phosphate, Cyclophosphamide, and Rituximab in Treating Patients With Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma"; n 529; "Progression-free Survival (PFS) Rate at 3 Years"; 2026-10-09
  • NCT04018937
    "Early Human Leukocyte Antigen (HLA) Matched Sibling Hematopoietic Stem Cell Transplantation"; n 43; "Immune Suppression-free, Rejection-free Survival"; 2026-11
  • NCT04187105
    "BMT-06: Study of Intensity Modulated Total Marrow Irradiation (IM-TMI)"; n 27; "Rate of 1 year Graft-Versus-Host Disease (GVHD) free, relapse free survival (GRFS) survival"; 2026-12
  • NCT04904588
    "HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation With Post-Transplantation Cyclophosphamide"; n 300; "Overall Survival"; 2026-12
14 further recorded trials
  • NCT05832515
    "AHSCT With Fludarabine and Cyclophosphamide Based Conditioning Regimes in Patients With Multiple Sclerosis"; n 200; "Multiple sclerosis progression free survival"; 2026-12-01
  • NCT04644016
    "Cord Blood Transplant in Children and Young Adults With Blood Cancers and Non-malignant Disorders"; n 31; "Treatment related mortality at 1 year after myeloablative cord transplant"; 2026-12-20
  • NCT06001385
    "HLA-Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation With Reduced Dose Post Transplantation Cyclophosphamide GvHD Prophylaxis"; n 313; "Infection Free Survival"; 2026-12-30
  • NCT05736419
    "A Study of Immune Suppression Treatment for People With Sickle Cell Disease or β-Thalassemia Who Are Going to Receive an Allogeneic Hematopoietic Cell Transplantation (HCT)"; n 24; "Number of participants with treatment related mortality/TRM or primary graft failure"; 2027-02-09
  • 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
  • NCT02727803
    "Personalized NK Cell Therapy in CBT"; n 100; "Progression free survival (PFS) time in C2C2 patients"; 2027-05-31
  • NCT07232953
    "Safety and Efficacy of FT14 Conditioning for Allogeneic HSCT in Acute Myeloid Leukemia"; n 82; "The 1-year leukemia -free survival (LFS) after allo-SCT"; 2027-06
  • NCT06342986
    "Intraperitoneal FT536 in Recurrent Ovarian, Fallopian Tube, and Primary Peritoneal Cancer"; n 3; "Progression free survival (PFS)"; 2027-06-30
  • NCT05303727
    "Allogeneic Hematopoietic Stem Cell Transplantation for 4/M Neuroblastoma"; n 64; "overall survival(OS) at 3 year"; 2027-08
  • NCT06028828
    "Risk-ADAPTed Conditioning Regimen for Allogeneic Hematopoietic Stem Cell Transplantation"; n 60; "Progression-free survival (PFS)"; 2027-09
  • NCT02250937
    "Venetoclax and Sequential Busulfan, Cladribine, and Fludarabine Phosphate Before Donor Stem Cell Transplant in Treating Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome"; n 116; "Progression free survival"; 2027-10-31
  • NCT06809699
    "Human Leukocyte Antigen (HLA) Mismatched Related Allogeneic Hematopoietic Stem Cell Transplantation"; n 29; "Overall survival"; 2027-10-31
  • NCT06809712
    "Human Leukocyte Antigen (HLA) Mismatched Unrelated Allogeneic Hematopoietic Stem Cell Transplantation"; n 29; "Overall survival"; 2027-10-31
  • NCT01962415
    "Reduced Intensity Conditioning for Non-Malignant Disorders Undergoing UCBT, BMT or PBSCT"; n 100; "Post-transplant treatment-related mortality (TRM)"; 2027-11

Which 204 trials of Fludarabine posted no result?


Posted no result
204 of 204 completed trials
Registrations
NCT00001422, NCT00001677, NCT00002833, NCT00002838, NCT00008151 and NCT00004246, and 198 more
Completion dates
oldest 2000-04; newest 2024-08-19
Show the evidence

Trial

  • NCT00001422
    2000-04
  • NCT00001677
    2000-04
  • NCT00002833
    2002-04
  • NCT00002838
    2002-07
  • NCT00008151
    2002-07
  • NCT00004246
    2002-12-02
14 further recorded trials
  • NCT00005593
    2003-03
  • NCT00004255
    2003-05
  • NCT00027924
    2003-05
  • NCT00006233
    2003-12
  • NCT00140569
    2004-01
  • NCT00003619
    2004-04
  • NCT00073879
    2004-04
  • NCT00027547
    2004-07
  • NCT00305708
    2004-07
  • NCT00688883
    2004-08
  • NCT00276809
    2004-09
  • NCT00027820
    2004-09-05
  • NCT00048412
    2004-11-12
  • NCT00005863
    2004-12

At the median, Fludarabine's trials enrolled 30 people — anything larger?


Median enrolment
30
Largest enrolment
6136
Registered trials counted
1516

What do 5809 spontaneous reports say about Fludarabine — 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.

Fludarabine appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 5809 reaction mentions were counted: febrile neutropenia 1124; pyrexia 925; neutropenia 683; cytomegalovirus infection 608. FAERS via Open Targets · CHEMBL1096882 · 2026-06-24

Show the evidence
  • febrile neutropenia
    1124
  • pyrexia
    925
  • neutropenia
    683
  • cytomegalovirus infection
    608
  • thrombocytopenia
    521
  • cytokine release syndrome
    494
4 more recorded rows
  • acute graft versus host disease
    435
  • mucosal inflammation
    369
  • pancytopenia
    330
  • myelodysplastic syndrome
    320

recorded 2026-06-24 · last checked 2026-09-04

Which 10 reactions does Fludarabine's label not list?


acute graft versus host disease, cytokine release syndrome and cytomegalovirus infection and 7 more reported for Fludarabine, absent from its label. FAERS via Open Targets · CHEMBL1096882 · 2026-06-24

2 label terms; 10 reported and unlisted; 8039c2e3-ffe5-3997-e053-2991aa0ad9d0

Show the evidence
  • acute graft versus host disease
    count not stated
  • cytokine release syndrome
    count not stated
  • cytomegalovirus infection
    count not stated
  • febrile neutropenia
    count not stated
  • mucosal inflammation
    count not stated
  • myelodysplastic syndrome
    count not stated
4 more recorded rows
  • neutropenia
    count not stated
  • pancytopenia
    count not stated
  • pyrexia
    count not stated
  • thrombocytopenia
    count not stated

recorded 2026-06-24 · last checked 2026-09-04

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL1096882
PubChem CID
657237
CAS number
21679-14-1
RxCUI
24698
InChIKey
GIUYCYHIANZCFB-FJFJXFQQSA-N
Salt form
Fludarabine Phosphate
Trade name
Oforta, Fludara, Oforta / Fludara
Also called
2-F-ARAA, 2-FLUORO ARA-A, 2-FLUORO-9-.BETA.-D-ARABINOFURANOSYLADENINE, 2-FLUOROVIDARABINE, 9-.BETA.-D-ARABINOFURANOSYL-2-FLUORO-9H-PURIN-6-AMINE, 9-.BETA.-D-ARABINOFURANOSYL-2-FLUOROADENINE, FLUDARABINE PHOSPHATE IMPURITY E [EP IMPURITY], FLUDARABINE PHOSPHATE IMPURITY, 2-FLUORO-ARA-ADENINE- [USP IMPURITY], FLUDARABINE [HSDB], FLUDARABINE [MI], FLUDARABINE [VANDF]
Sources (6)

Sources

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

How these records are assembled · Which registers were checked

Index-quality checks
  • identity passed: no open identity hold
  • 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: 6 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

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