Radioactive therapy targets stubborn leukemia in early trial

NCT ID NCT06356922

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 30, 2026 · Updated 2 times

Summary

This study tests a new radioactive drug called [177Lu]Lu-PentixaTher in people with acute leukemia that has come back or not responded to standard treatments. The drug seeks out and delivers radiation directly to leukemia cells that have a specific marker (CXCR4). The main goals are to find the safest dose and see if it can shrink the cancer. About 21 adults will take part in this early-phase trial.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 21 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age ≥ 18 years * AML/ALL (OMS) with \>5% of blasts in bone marrow (with or without extramedullary localisation) * CXCR4+ (ratio \>2/isotypic control) at the time of pre-inclusion * All previously treated AML/ALL patients who have experienced relapse or treatment failure with no alternative treatment * At least 15 days since previous treatment * Eastern Cooperative Oncology Group (ECOG) performance status \< 2 * eGFR ≥ 50 ml/min by MDRD or CKDEPI * ASAT or ALAT \> 5 upper normal value (except in case of documented presence of leukemia in the liver) * Serum bilirubin ≤ 30 µmol/l * Negative pregnancy test documented prior to enrolment (for females of childbearing potential) * Agree to use an effective form of contraception with sexual partners throughout study participation (for female and male patients who are fertile) * No active cardiac dysfunction (LVEF \> 45%) * DLCO \>40% * Written informed consent * Be willing and able to comply with scheduled visits and study procedures * Affiliation with French social security system or beneficiary from such system Exclusion Criteria: * Meningeal involvement * HIV positive * Active Hepatitis B or C * Active infection within 7 days of starting treatment * Previous or concurrent second malignancy except for adequately treated basal cell carcinoma of the skin, curatively treated in situ carcinoma of the cervix, curatively treated solid cancer, with no evidence of disease for at least 1 year * Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule * Participation at the same time in another study in which investigational drugs are used * Patient with contra-indications to Rhu-EPO, Rhu-GCSF, allopurinol, rasburicase, anti-histamines and corticosteroids * Absence of written informed consent * Pregnant or child breast feeding woman * Patient under guardianship or trusteeship * Patient under judicial protection

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • CHU d'Angers

    Angers, Maine et Loire, 49100, France

  • CHU de Bordeaux

    Bordeaux, Gironde, 33604, France

  • CHU de Clermont-Ferrand

    Clermont-Ferrand, Puy de Dôme, 63000, France

  • CHU de Nantes

    Nantes, Loire-Atlantique, 44000, France

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