Actively Recruiting
Study Assessing RLT Using [177Lu]Lu-PentixaTher for Relapsed/Refractory CXCR4+ Acute Leukemia.
Led by Nantes University Hospital · Updated on 2026-04-16
21
Participants Needed
4
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
CXCR4 inhibition may represent a new therapeutic strategy in acute leukemia (AL) patients, not only by increasing chemosensitivity but also by preventing relapse of the disease by disruption of the interaction of residual leukemic cells with the bone marrow niche. Radiolabeled CXCR4 ligands have been developed for PET imaging (68Ga-PentixaFor; INN: Gallium (68Ga) boclatixafortide) and radioligand therapy (RLT) (\[177Lu\]Lu-PentixaTher/\[90Y\]Y-PentixaTher). \[177Lu\]Lu and \[90Y\]Y-PentixaTher have been tested in three multiple myeloma patients in named-patient use with a remarkable efficacy in 2 patients (Herrmann, 2016). Moreover, feasibility of CXCR4 PET imaging in AML was reported, providing a framework for future theranostic approaches targeting the CXCR4/CXCL12-defined leukemia-initiating cell niche (Herhaus, 2016). Here a Phase I/II study to determine maximal tolerated dose (MTD) of a RLT using \[177Lu\]Lu-PentixaTher in relapsed/refractory AL was designed. This will be a standard phase I/II 3+3 dose escalation study. Five dose levels will be tested, so 6 to 21 patients have to be included in the study.
CONDITIONS
Official Title
Study Assessing RLT Using [177Lu]Lu-PentixaTher for Relapsed/Refractory CXCR4+ Acute Leukemia.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosis of AML or ALL with more than 5% blasts in bone marrow
- Positive CXCR4 expression (ratio >2 compared to control) at pre-inclusion
- Relapsed or treatment-failure AML/ALL patients with no alternative treatments
- At least 15 days since last treatment
- ECOG performance status less than 2
- Estimated glomerular filtration rate (eGFR) 50 ml/min or higher
- Liver enzymes ASAT or ALAT greater than 5 times upper normal value unless leukemia is present in liver
- Serum bilirubin 30 micromol/l or lower
- Negative pregnancy test before enrollment for females who can become pregnant
- Agreement to use effective contraception during study for fertile male and female patients
- No active heart dysfunction (left ventricular ejection fraction over 45%)
- Lung function (DLCO) greater than 40%
- Provide written informed consent
- Ability and willingness to follow study visits and procedures
- Affiliation with or beneficiary of French social security system
You will not qualify if you...
- Meningeal involvement
- HIV positive status
- Active Hepatitis B or C infection
- Active infection within 7 days before starting treatment
- Previous or current second cancer except certain treated cancers with no disease for at least 1 year
- Any psychological, family, social, or geographic condition that might interfere with study compliance
- Participation in another study using investigational drugs
- Contraindications to specific supportive treatments such as Rhu-EPO, Rhu-GCSF, allopurinol, rasburicase, anti-histamines, or corticosteroids
- Lack of written informed consent
- Pregnant or breastfeeding women
- Under guardianship, trusteeship, or judicial protection
AI-Screening
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Trial Site Locations
Total: 4 locations
1
CHU de Bordeaux
Bordeaux, Gironde, France, 33604
Actively Recruiting
2
CHU de Nantes
Nantes, Loire-Atlantique, France, 44000
Actively Recruiting
3
CHU d'Angers
Angers, Maine et Loire, France, 49100
Actively Recruiting
4
CHU de Clermont-Ferrand
Clermont-Ferrand, Puy de Dôme, France, 63000
Actively Recruiting
Research Team
P
Patrice CHEVALLIER
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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