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RECRUITING
NCT06356922
PHASE1/PHASE2

Study Assessing RLT Using [177Lu]Lu-PentixaTher for Relapsed/Refractory CXCR4+ Acute Leukemia.

Sponsor: Nantes University Hospital

View on ClinicalTrials.gov

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

DRUG

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