protocolSection identificationModule nctId: NCT06356922, orgStudyIdInfo id: RC20_0123, briefTitle: Study Assessing RLT Using [177Lu]Lu-PentixaTher for Relapsed/Refractory CXCR4+ Acute Leukemia., acronym: PENTILULA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-15, primaryCompletionDateStruct date: 2027-05-15, completionDateStruct date: 2027-05-15, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Nantes University Hospital, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Acute Leukemia, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 21, type: ESTIMATED, armsInterventionsModule interventions name: Experimental drug [177Lu]Lu-PentixaTher, outcomesModule primaryOutcomes measure: Safety of RLT using one injection of [177Lu]Lu-PentixaTher, primaryOutcomes measure: Tolerance, secondaryOutcomes measure: Overall response rate, secondaryOutcomes measure: Complete response rate, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Leukemia-free survival, secondaryOutcomes measure: Minimal residual disease, secondaryOutcomes measure: Whole-body biodistribution, secondaryOutcomes measure: Serum uptake, secondaryOutcomes measure: Radiation dosimetry, secondaryOutcomes measure: Renal safety, secondaryOutcomes measure: Renal safety, secondaryOutcomes measure: Renal safety, secondaryOutcomes measure: Renal safety, secondaryOutcomes measure: Correlation between different cytokines and toxicity, secondaryOutcomes measure: Factors associated response, secondaryOutcomes measure: Exploratory outcome measure = Identification of biological biomarkers, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHU de Bordeaux, city: Bordeaux, state: Gironde, zip: 33604, country: France, contacts name: DUMAS Pierre-Yves, role: CONTACT, contacts name: pierre-yves.dumas@chu-bordeaux.fr, role: CONTACT, geoPoint lat: 44.84044, lon: -0.5805, locations facility: CHU de Nantes, city: Nantes, state: Loire-Atlantique, zip: 44000, country: France, contacts name: Patrice CHEVALLIER, role: CONTACT, phone: 00332 40 08 39 94, email: patrice.chevallier@chu-nantes.fr, geoPoint lat: 47.21725, lon: -1.55336, locations facility: CHU d'Angers, city: Angers, state: Maine Et Loire, zip: 49100, country: France, contacts name: HUNAULT Mathilde, role: CONTACT, email: mahunault@chu-angers.fr, geoPoint lat: 47.46667, lon: -0.55, locations facility: CHU de Clermont-Ferrand, city: Clermont-Ferrand, state: Puy De Dôme, zip: 63000, country: France, contacts name: MOLUCON Cécile, role: CONTACT, email: cecile.chabrot@chu-clermontferrand.fr, geoPoint lat: 45.77966, lon: 3.08628, hasResults: False