RecruitingPhase 1Phase 2NCT06356922

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

Phase I/II Study Assessing Radioligand Therapy (RLT) Using [177Lu]Lu-PentixaTher for Relapsed/Refractory CXCR4+ Acute Leukemia.

Sponsor

Nantes University Hospital

Enrollment

21 participants

Start Date

Oct 22, 2024

Study Type

INTERVENTIONAL

Conditions

Acute Leukemia

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.

Eligibility

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study tests a targeted radioactive treatment using a drug called [177Lu]Lu-PentixaTher — which specifically seeks out a protein called CXCR4 found on leukemia cells — for patients with relapsed or treatment-resistant acute leukemia (AML or ALL) who have no other treatment options. **You may be eligible if...** - You are 18 or older with acute myeloid or lymphoblastic leukemia (AML or ALL) - Your bone marrow shows more than 5% leukemia cells - Your cancer cells test positive for the CXCR4 protein - You have already tried all available treatments and your leukemia has relapsed or not responded - You are at least 15 days past your last treatment - Your kidney, liver, and heart function meet the required thresholds - You are affiliated with the French social security system **You may NOT be eligible if...** - Your leukemia has spread to the brain or spinal fluid - You have HIV, active hepatitis B or C, or an active infection - You have a current second cancer (with some exceptions) - You are pregnant or unwilling to use contraception Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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