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Study Assessing RLT Using [177Lu]Lu-PentixaTher for Relapsed/Refractory CXCR4+ Acute Leukemia.
Sponsor: Nantes University Hospital
Summary
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.
Official title: Phase I/II Study Assessing Radioligand Therapy (RLT) Using [177Lu]Lu-PentixaTher for Relapsed/Refractory CXCR4+ Acute Leukemia.
Key Details
Gender
All
Age Range
18 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
21
Start Date
2024-10-22
Completion Date
2027-10-22
Last Updated
2025-05-16
Healthy Volunteers
No
Conditions
Interventions
Experimental drug [177Lu]Lu-PentixaTher
Injection of \[177Lu\]Lu-PentixaTher
Locations (4)
CHU de Bordeaux
Bordeaux, Gironde, France
CHU de Nantes
Nantes, Loire-Atlantique, France
CHU d'Angers
Angers, Maine et Loire, France
CHU de Clermont-Ferrand
Clermont-Ferrand, Puy de Dôme, France