Radioactive therapy targets stubborn leukemia in early trial
NCT ID NCT06356922
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 Hide 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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Acute leukemia are added.
By submitting, you agree to our Terms of use
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
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Department of hematology, the second affiliated hospital of kunming medical university.
- The prognostic significance of C-Reactive protein to albumin ratio, albumin to fibrinogen ratio, and serum ferritin level in newly diagnosed de novo Non-M3 acute myeloid leukemia patients
- A phase i study to evaluate the safety and immunogenicity of 3D189 in patients with hematologic malignancies
- Impact of aloe vera mouthwash on the prevention and severity of oral mucositis in adults in with hematologic malignancies
- Can a Chemo-Only prep beat radiation for childhood leukemia transplants?
- Can a targeted drug hit the mark in Hard-to-Treat blood cancers?